Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018

I, General the Honourable Sir Peter Cosgrove AK MC (Ret’d), Governor‑General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following regulations.

Dated 15 March 2018

Peter Cosgrove

Governor‑General

By His Excellency’s Command

Greg Hunt

Minister for Health

Contents

1 Name

2 Commencement

3 Authority

4 Schedules

Schedule 1—Provisional registration of medicine

Therapeutic Goods Regulations 1990

Schedule 2—Complementary medicines

Therapeutic Goods Regulations 1990

Schedule 3—Australian conformity assessment body certificates and determinations

Part 1—Main amendments

Therapeutic Goods (Medical Devices) Regulations 2002

Part 2—Amendments consequential on the Therapeutic Goods Amendment (2017 Measures No. 1) Act 2018

Therapeutic Goods (Medical Devices) Regulations 2002

Schedule 4—Advertising

Part 1—Enforcement

Therapeutic Goods Regulations 1990

Part 2—Removal of requirement for advertisements to be approved

Therapeutic Goods Regulations 1990

Part 3—Other amendments

Therapeutic Goods Regulations 1990

Schedule 5—Infringement notices

Therapeutic Goods Regulations 1990

Schedule 6—Preliminary assessment of applications

Therapeutic Goods (Medical Devices) Regulations 2002

Therapeutic Goods Regulations 1990

Schedule 7—Miscellaneous amendments

Therapeutic Goods (Medical Devices) Regulations 2002

1  Name

  This instrument is the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018.

2  Commencement

 (1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

 (2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3  Authority

  This instrument is made under the Therapeutic Goods Act 1989.

4  Schedules

  Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

Schedule 1—Provisional registration of medicine

Therapeutic Goods Regulations 1990

1  Paragraph 9B(1)(d)

After “registered goods”, insert “or in the part of the Register for goods known as provisionally registered goods”.

2  Paragraph 10(a)

Before “therapeutic goods” (first occurring), insert “subject to paragraph (aa),”.

3  Paragraph 10(a)

Omit “part of the Register for registered goods”, substitute “part of the Register for goods known as registered goods”.

4  After paragraph 10(a)

Insert:

 (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and

5  Paragraph 10(b)

Omit “part of the Register for listed goods”, substitute “part of the Register for goods known as listed goods”.

6  After Part 2C

Insert:

Part 2D—Provisional determinations for medicine

10K  Applications for provisional determinations

  For the purposes of subsection 22C(1) of the Act, the kinds of medicine are the following:

 (a) new prescription medicine;

 (b) new indications medicine.

10L  Provisional determinations

  For the purposes of subsection 22D(2) of the Act, the criteria are all of the following:

 (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;

 (b) either:

 (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or

 (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;

 (c) there is preliminary clinical data demonstrating that the medicine is likely to provide a major therapeutic advance;

 (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.

7  Subparagraphs 16J(3)(f)(i) and (ii)

After “Register”, insert “(except in the part of the Register for goods known as provisionally registered goods)”.

8  Subparagraphs 16J(4)(e)(i) and (ii)

After “Register”, insert “(except in the part of the Register for goods known as provisionally registered goods)”.

9  Subparagraphs 16R(2)(c)(i) and (ii)

After “Register”, insert “(except in the part of the Register for goods known as provisionally registered goods)”.

10  After regulation 43AD

Insert:

43AE  Fee for application for provisional determination relating to medicine—refund in certain circumstances

 (1) This regulation applies if:

 (a) a person applies to the Secretary under regulation 16H to designate a medicine as an orphan drug; and

 (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and

 (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and

 (d) after the person pays the fee, the Secretary designates the medicine as an orphan drug under regulation 16J.

 (2) The Secretary must refund the fee to the person (whether or not the Secretary makes the determination).

11  Before paragraph 45(12)(c)

Insert:

 (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;

 (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;

12  In the appropriate position in Part 9

Insert:

Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018

60  Application provisions

 (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.

 (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.

 (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.

 (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.

13  Schedule 3 (heading)

Repeal the heading, substitute:

Schedule 3—Therapeutic goods required to be included in the part of the Register for goods known as registered goods or as provisionally registered goods

14  Clause 3 of Schedule 9 (after table item 1)

Insert:

15  Clause 3 of Schedule 9 (table item 4, column 2, paragraph (a))

Omit “applies”, substitute “of this item, paragraph (a) of item 1AD or item 1AF applies”.

16  Clause 3 of Schedule 9 (table item 4, column 2, paragraph (b))

Omit “applies”, substitute “of this item, paragraph (b) of item 1AD or item 1AF applies”.

Schedule 2—Complementary medicines

Therapeutic Goods Regulations 1990

1  Regulation 2

Insert:

changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.

IN1 application means an application made under subsection 26BE(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.

IN2 application means an application made under subsection 26BE(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:

 (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and

 (b) an independent evaluation of the quality of the ingredient.

IN3 application means an application made under subsection 26BE(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:

 (a) an evaluation of the quality of an ingredient based on:

 (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or

 (ii) a monograph contained in a default standard; and

 (b) an independent evaluation of the safety of the ingredient.

IN4 application means an application made under subsection 26BE(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.

independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.

L(A)1 application means an application made under section 23 of the Act to list a complementary medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).

L(A)2 application means an application made under section 23 of the Act to list a complementary medicine under section 26AE of the Act, if:

 (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:

 (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and

 (ii) has the same pharmaceutical form; and

 (iii) is bioequivalent; and

 (iv) has the same safety and efficacy properties; or

 (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.

L(A)3 application means an application made under section 23 of the Act to list a complementary medicine under section 26AE of the Act, if:

 (a) either:

 (i) the application requires an independent evaluation of the efficacy of the medicine; or

 (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and

 (b) the application is not an L(A)1 application or an L(A)2 application.

RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).

RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.

RCM3 application means an application made under section 23 of the Act to register a complementary medicine, if:

 (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or

 (b) the application requires an independent evaluation of one of the following:

 (i) the safety of the medicine;

 (ii) the quality of the medicine;

 (iii) the efficacy of the medicine.

RCM4 application means an application made under section 23 of the Act to register a complementary medicine, if:

 (a) the application requires an independent evaluation of 2 of the following:

 (i) the safety of the medicine;

 (ii) the quality of the medicine;

 (iii) the efficacy of the medicine; or

 (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or

 (c) the application is for a medicine that is registered and is for one or more of the following:

 (i) an extension of indications of the medicine;

 (ii) new directions for use of the medicine;

 (iii) an increase in the target population for the medicine.

RCM5 application means an application made under section 23 of the Act to register a complementary medicine, if:

 (a) either:

 (i) the application requires an independent evaluation of the safety, quality and efficacy of the medicine; or

 (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and

 (b) the application is not an RCM1 application, an RCM2 application, an RCM3 application or an RCM4 application.

RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.

RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:

 (a) the application is for a change to the entry of a registered complementary medicine (the existing medicine), the effect of which (if approved) would result in the medicine becoming separate and distinct for the purposes of Part 3‑2 of the Act; and

 (b) the change is of a kind specified in the changes table as an RCMC1 (section 23) level change; and

 (c) the new medicine, if registered would form part of the same gazetted therapeutic goods group as the existing medicine.

RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.

RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:

 (a) the application is for a change to the entry of a registered complementary medicine (the existing medicine), the effect of which (if approved) would result in the medicine becoming separate and distinct for the purposes of Part 3‑2 of the Act; and

 (b) the change is of a kind specified in the changes table as an RCMC2 (section 23) level change; and

 (c) the new medicine, if registered would form part of the same gazetted therapeutic goods group as the existing medicine.

RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.

RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:

 (a) the application is for a change to the entry of a registered complementary medicine (the existing medicine), the effect of which (if approved) would result in the medicine becoming separate and distinct for the purposes of Part 3‑2 of the Act; and

 (b) the change is of a kind specified in the changes table as an RCMC3 (section 23) level change; and

 (c) the new medicine, if registered would form part of the same gazetted therapeutic goods group as the existing medicine.

RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.

RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:

 (a) the application is for a change to the entry of a registered complementary medicine (the existing medicine), the effect of which (if approved) would result in the medicine becoming separate and distinct for the purposes of Part 3‑2 of the Act; and

 (b) the change is of a kind specified in the changes table as an RCMC4 (section 23) level change; and

 (c) the new medicine, if registered would form part of the same gazetted therapeutic goods group as the existing medicine.

2  At the end of regulation 3AA

Add:

 ; or (d) a medicine that satisfies the following requirements:

 (i) the medicine only contains indications that are covered by a determination under paragraph 26BF(1)(a) of the Act;

 (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.

3  At the end of subregulation 10AA(1)

Add:

 ; (e) the definition of RCMC1 (section 9D) request;

 (f) the definition of RCMC2 (section 9D) request;

 (g) the definition of RCMC3 (section 9D) request;

 (h) the definition of RCMC4 (section 9D) request.

4  Subparagraph 11(2)(b)(v)

Repeal the subparagraph.

5  Subparagraph 15(1)(c)(ii)

Repeal the subparagraph, substitute:

 (ii) unless subparagraph (iii) applies—“AUST L” in the case of listed goods; and

 (iii) “AUST L(A)” in the case of goods listed under section 26AE of the Act;

6  Subregulation 15(2)

Omit “or (ii)”, substitute “, (ii) or (iii)”.

7  At the end of Part 3A

Add:

Division 4—Complementary medicines

16GG  Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made

 (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.

 (2) If the Secretary receives a request of a kind mentioned in column 1 of an item in the following table:

 (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and

 (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.

 (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.

16GH  Registration and listing of certain complementary medicines—notification of preliminary assessment of applications and period within which evaluations must be completed

 (1) If the Secretary receives an application of a kind mentioned in column 1 of an item in the following table:

 (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and

 (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.

 (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.

16GI  Variation of section 26BB determinations—notification of acceptance or rejection of applications and period within which recommendation decisions must be made

 (1) If the Secretary receives an application of a kind mentioned in column 1 of an item in the following table:

 (a) the Secretary must notify the applicant in writing as to whether the application has been accepted or rejected within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and

 (b) if the application is accepted—a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.

 (2) A failure to decide an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.

16GJ  Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications

  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following complementary medicine applications:

 (a) an IN1 application;

 (b) an IN2 application;

 (c) an IN3 application;

 (d) an L(A)2 application;

 (e) an RCM2 application;

 (f) an RCM3 application;

 (g) an RCM4 application.

8  Subparagraph 23(2)(a)(ii)

Omit “subsection 28(5A) or 41FN(2)”, substitute “paragraph 28(5)(h) or subsection 41FN(2)”.

9  Paragraphs 25(3)(b) and (c)

Omit “subsection 28(5A) or 41FN(2)”, substitute “paragraph 28(5)(h) or subsection 41FN(2)”.

10  Subregulation 26A(1)

Omit “subsection 28(5A) or 41FN(2)”, substitute “paragraph 28(5)(h) or subsection 41FN(2)”.

11  Subregulations 31(1A) and (2)

Omit “subsection 28(5A) or 41FN(2)”, substitute “paragraph 28(5)(h) or subsection 41FN(2)”.

12  After paragraph 43(1)(a)

Insert:

 (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and

13  At the end of regulation 43A

Add:

 (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:

 (a) the application is for the listing of medicine (the relisted medicine) under section 26A of the Act; and

 (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and

 (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and

 (d) the application is made within the period of 18 months beginning on the day Schedule 2 to the Therapeutic Goods Amendment (2017 Measures No. 1) Act 2018 commences.

14  After regulation 43AC

Insert:

43ACA  Refund of fees where no evaluation undertaken—registered complementary medicines

 (1) This regulation applies if:

 (a) a person makes an application of a kind mentioned in item 2, 3 or 4 of the table in Part 4 of Schedule 9; and

 (b) the person has paid the application fee required under the item in respect of the application; and

 (c) an evaluation of documentation in respect of the application is not undertaken.

 (2) The Secretary must refund to the person the following amount:

 (a) for an RCMC2 (section 9D) request—$3,960;

 (b) for an RCMC3 (section 9D) request—$6,190;

 (c) for an RCMC4 (section 9D) request—$9,160.

15  Before regulation 44

Insert:

43AF  Fee for request for variation of registered complementary medicines—refund in certain circumstances

  If:

 (a) a person (the applicant) makes a request under section 9D of the Act; and

 (b) the request is:

 (i) an RCMC2 (section 9D) request; or

 (ii) an RCMC3 (section 9D) request; or

 (iii) an RCMC4 (section 9D) request; and

 (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;

then 25% of the application fee must be refunded to the applicant.

16  After subregulation 45(3)

Insert:

 (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:

 (a) the application is of a kind mentioned in subregulation (3B); and

 (b) the applicant makes one or more additional applications of the same kind; and

 (c) each application relates to goods that contain the same therapeutically active ingredient; and

 (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.

 (3B) The applications are as follows:

 (a) an L(A)1 application;

 (b) an L(A)2 application;

 (c) an L(A)3 application;

 (d) an RCM1 application;

 (e) an RCM2 application;

 (f) an RCM3 application;

 (g) an RCM4 application;

 (h) an RCM5 application.

17  After paragraph 45(4)(a)

Insert:

 (aa) to list goods under section 26AE of the Act; or

18  In the appropriate position in Division 7 of Part 9

Insert:

61  Operation of Schedule 2—complementary medicines

 (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.

 (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.

19  Schedule 4 (table item 3, column headed “Therapeutic goods”, paragraph (d))

Repeal the paragraph, substitute:

(d) the medicine only contains indications that are covered by a determination under paragraph 26BF(1)(a) of the Act; and

(e) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to the indications—none of the requirements have been contravened

20  Schedule 4 (table item 4A, column headed “Therapeutic goods”, paragraph (e))

Repeal the paragraph, substitute:

(e) none of the ingredients in the preparation are included in a Schedule to the Poisons Standard or Appendix C of the Poisons Standard (other than any ingredient that is more than a 1,000‑fold dilution of mother tincture); and

(f) the preparation only contains indications that are covered by a determination under paragraph 26BF(1)(a) of the Act; and

(g) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to the indications—none of the requirements have been contravened

21  Schedule 4 (table item 5, column headed “Therapeutic goods”, paragraph (e))

Repeal the paragraph, substitute:

(e) the preparation only contains indications that are covered by a determination under paragraph 26BF(1)((a) of the Act; and

(f) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to the indications—none of the requirements have been contravened

22  Schedule 4 (after table item 7)

Insert:

23  Schedule 5A (table item 1A, column 2)

After “26A,”, insert “26AE,”.

24  Part 2 of Schedule 9 (heading)

Repeal the heading, substitute:

Part 2—Table of fees other than for applications etc. covered by Part 3 or 4

25  Clause 3 of Schedule 9

Omit “Part 3.”, substitute “Part 3 or 4.”.

26  Clause 3 of Schedule 9 (table item 2, column 2, paragraphs (a) and (f))

Repeal the paragraphs.

27  Clause 3 of Schedule 9 (table item 2, column 3)

Omit “1,530”.

28  Clause 3 of Schedule 9 (table item 2, column 3)

Omit “680”.

29  Clause 3 of Schedule 9 (table item 2A, column 2, paragraph (b))

Repeal the paragraph.

30  Clause 3 of Schedule 9 (table item 2A, column 3)

Omit “1,530”.

31  Clause 3 of Schedule 9 (table item 5)

Repeal the item.

32  Clause 3 of Schedule 9 (table items 7C and 7D)

Repeal the items, substitute:

33  At the end of Schedule 9

Add:

Part 4—Table of fees for applications etc. in relation to certain complementary medicines

5  Table of fees

  The following table sets out particular fees for applications, evaluations and requests in relation to certain complementary medicines.

Schedule 3—Australian conformity assessment body certificates and determinations

Part 1—Main amendments

Therapeutic Goods (Medical Devices) Regulations 2002

1  Before Division 4.2

Insert:

Division 4.1B—Content of conformity assessment certificates

4.3F  Content of conformity assessment certificates

  For the purposes of subsection 41EE(3) of the Act, the information is all of the following:

 (a) a unique identification number for the certificate;

 (b) the day on which the certificate is issued;

 (c) the name and address of the manufacturer of the medical devices;

 (d) the conformity assessment procedures applied to the medical devices by the manufacturer;

 (e) if the certificate covers a medical device to which paragraph 1.6(a), (b) or (c) applies—the unique product identifier given to the device by the manufacturer;

 (f) the conditions to which the certificate is subject under section 41EJ or 41EK of the Act;

 (g) if one or more conformity assessment certificates have previously been issued in respect of the medical devices—the day on which each of those certificates was issued;

 (h) the signature and name of the person issuing the certificate.

2  After Part 4

Insert:

Part 4A—Australian conformity assessment bodies

Division 4A.1—Preliminary

4A.1  Purposes of this Part

 (1) This Part (other than Division 4A.7) is made for the purposes of section 41EWA of the Act (about Australian conformity assessment bodies).

 (2) Division 4A.7 is made for the purposes of section 41EWB of the Act (about the content of Australian conformity assessment body certificates).

Division 4A.2—Making conformity assessment body determinations

4A.2  Applications

 (1) An Australian corporation may apply to the Secretary for a conformity assessment body determination in respect of the corporation.

 (2) The application must:

 (a) be made:

 (i) in writing; and

 (ii) in a form (if any) approved under subregulation (4); and

 (iii) in a manner (if any) approved under subregulation (4); and

 (b) be delivered to an office of the Department specified under subregulation (6).

 (3) The application is not effective if:

 (a) the application does not meet the requirements of subregulation (2) and regulation 4A.4; or

 (b) the application contains information that is false or misleading in a material particular; or

 (c) the application fee for the application has not been paid.

Note 1: For the application fee, see regulation 9.1 and Part 1 of Schedule 5.

Note 2: A conformity assessment body determination assessment fee is payable under Division 9.2 for assessment of the application.

Forms and manners

 (4) For the purposes of subparagraph (2)(a)(ii) or (iii), the Secretary may, in writing, approve a form or manner for making an application for a conformity assessment body determination.

 (5) The Secretary may approve different forms and manners for different classes of conformity assessment body determinations.

Offices

 (6) For the purposes of paragraph (2)(b), the Secretary may, in writing, specify an office of the Department to which applications for conformity assessment bodies must be delivered.

 (7) The Secretary may specify different offices for different classes of conformity assessment body determinations.

4A.3  Further information

 (1) For the purposes of assessing an application for a conformity assessment body determination, the Secretary may, by written notice given to the applicant, require the applicant to deliver specified information or documents:

 (a) to the office of the Department to which the application was delivered; and

 (b) within the period, of not less than 10 working days after the day the notice is given, specified in the notice; and

 (c) in a manner (if any) specified in the notice; and

 (d) in accordance with regulation 4A.4.

 (2) For the purposes of assessing an application for a conformity assessment body determination, the Secretary may:

 (a) by written notice given to the applicant, require the applicant to allow an authorised person, at any reasonable time specified in the notice, to inspect specified premises (including premises outside Australia) that are or will be used by the applicant to carry on certification‑related activities; or

 (b) by written notice given to a contractor of the applicant, require the contractor to allow an authorised person, at any reasonable time specified in the notice, to inspect specified premises (including premises outside Australia) that are or will be used by the contractor to carry on certification‑related activities for the applicant.

Note: For authorised person, see subsection 3(1) of the Act.

 (3) If the Secretary gives a notice to a contractor under paragraph (2)(b), the Secretary must give a copy of the notice to the applicant.

4A.4  Documents to be provided in English

  All documents (including correspondence) provided by an applicant in relation to an application for a conformity assessment body determination:

 (a) must be provided in English; and

 (b) may also be provided in any other language.

4A.5  Lapsing of applications

  An application for a conformity assessment body determination lapses if:

 (a) the applicant, or a contractor of the applicant, fails to comply with a notice under subregulation 4A.3(1) or (2) in relation to the application; or

 (b) information given to the Secretary by, or on behalf of, the applicant in connection with the application, including information given for the purposes of a notice under subregulation 4A.3(1), is false or misleading in a material particular; or

 (c) for the whole or a part of the conformity assessment body determination assessment fee for the application that is due and payable as mentioned in Division 9.2—the applicant fails to pay that whole or part in accordance with that Division.

4A.6  Assessing applications

 (1) If an application is made in accordance with regulation 4A.2 for a conformity assessment body determination in respect of an Australian corporation, the Secretary must decide whether to make the conformity assessment body determination.

Conditions and criteria for making determinations

 (2) The Secretary must not decide to make the determination unless he or she is satisfied that it is likely that the Australian corporation will be able to comply with the requirements of Schedule 3AA throughout the period specified in the determination as mentioned in paragraph 4A.8(2)(b).

 (3) In deciding whether to make the conformity assessment body determination, the Secretary must also consider:

 (a) whether at least one of the following persons:

 (i) the Australian corporation;

 (ii) a person (a manager) who makes, or participates in making, decisions that affect the whole, or a substantial part, of the Australian corporation’s affairs;

 (iii) a major interest holder of the Australian corporation;

  has, within the 10 years immediately before the application:

 (iv) been convicted of an offence against the Act or a corresponding State law; or

 (v) been convicted of an offence against a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or

 (vi) been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of the Act or a corresponding State law; or

 (vii) been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or

 (viii) breached a condition of a conformity assessment body determination; or

 (ix) had a conformity assessment body determination in respect of the person suspended or revoked; or

 (x) been a manager, or a major interest holder, of a body corporate in respect of which subparagraph (iv), (v), (vi), (vii), (viii) or (ix) applies in that 10 years, if the conduct resulting in that subparagraph applying occurred when the person was a manager or major interest holder of the body corporate; and

 (b) any other relevant matter.

 (4) A reference in paragraph (3)(a) to a person convicted of an offence includes a reference to a person in respect of whom an order has been made relating to the offence under:

 (a) section 19B of the Crimes Act 1914; or

 (b) a corresponding provision of a law of a State or Territory.

Note: Section 19B of the Crimes Act 1914 empowers a court that has found a person to have committed an offence to take action without proceeding to record a conviction.

 (5) Nothing in this regulation affects the operation of Part VIIC of the Crimes Act 1914 (which includes provisions that, in certain circumstances, relieve persons from the requirement to disclose spent convictions and require persons aware of such convictions to disregard them).

 (6) Subregulation (2) and paragraph (3)(a) do not limit paragraph (3)(b).

4A.7  Procedure following decisions to make determinations

 (1) This regulation applies if the Secretary decides under subregulation 4A.6(1) to make a conformity assessment body determination in respect of an Australian corporation.

 (2) The Secretary must notify the Australian corporation within 20 working days.

 (3) When all conformity assessment body determination assessment fees that are due and payable for the application have been paid, the Secretary must:

 (a) make the determination, including specifying:

 (i) the scope of the determination in accordance with subregulation (4); and

 (ii) the commencement and duration of the determination in accordance with regulation 4A.8; and

 (b) give it to the corporation.

 (4) The conformity assessment body determination must specify whether it:

 (a) is of general application; or

 (b) is limited to either or both of the following:

 (i) one or more specified medical devices;

 (ii) one or more specified conformity assessment procedures.

 (5) The conformity assessment body determination may specify conditions to which it is subject.

Note: See regulation 4A.19.

4A.8  Duration of determinations

 (1) A conformity assessment body determination commences on the day specified for the purpose in the determination under subparagraph 4A.7(3)(a)(ii).

 (2) A conformity assessment body determination has effect at all times:

 (a) unless the determination is suspended under Division 4A.4; or

 (b) until the end of the period specified in the determination under subparagraph 4A.7(3)(a)(ii); or

 (c) until the determination is revoked under Division 4A.5.

 (3) The period specified in the determination as mentioned in paragraph (2)(b) must be 5 years or less, starting on the day the determination commences.

4A.9  Procedure following decisions not to make determinations

 (1) This regulation applies if the Secretary decides under subregulation 4A.6(1) not to make a conformity assessment body determination in respect of an Australian corporation.

 (2) The Secretary must notify the Australian corporation within 20 working days.

 (3) The notice must state the reasons for the decision.

Division 4A.3—Conditions on conformity assessment body determinations

Subdivision A—Automatic conditions on determinations

4A.10  Automatic conditions on determinations

  A conformity assessment body determination is subject to the conditions set out in this Subdivision.

Note: See sections 41MN and 41MNA of the Act for offences and civil penalty provisions that apply to breaching a condition of a conformity assessment body determination.

4A.11  Conditions—requirements of Schedule 3AA

  The Australian conformity assessment body will comply with the requirements of Schedule 3AA.

4A.12  Conditions—notifying Secretary and clients

 (1) The Australian conformity assessment body will notify the Secretary within 10 working days if there are any substantial changes relating to the body’s compliance with the requirements of Schedule 3AA.

 (2) The Australian conformity assessment body will notify the Secretary and relevant clients of the body as soon as practicable if the body plans to cease carrying on one or more kinds of certification‑related activities relating to conformity assessment procedures covered by the determination.

 (3) The notice under subregulation (2) must specify the day on which the body plans to cease carrying on the activity.

4A.13  Conditions—entry and inspection

 (1) The Australian conformity assessment body will allow an authorised person:

 (a) to enter, at any reasonable time, premises used by the body to carry on certification‑related activities; and

 (b) while on those premises, to inspect those premises and anything on those premises that concerns certification‑related activities carried on by the body; and

 (c) while on those premises, to make any still or moving image or any recording of those premises or anything on those premises that concerns certification‑related activities carried on by the body; and

 (d) while on those premises, to inspect, and make copies of, any documents that concern certification‑related activities carried on by the body.

 (2) The Australian conformity assessment body will have procedures, including a written agreement, in place with each contractor of the body that carries on certification‑related activities for the body that require the contractor to allow an authorised person:

 (a) to enter, at any reasonable time, premises used by the contractor to carry on those certification‑related activities; and

 (b) while on those premises, to inspect those premises and anything on those premises that concerns those certification‑related activities; and

 (c) while on those premises, to make any still or moving image or any recording of those premises or anything on those premises that concerns those certification‑related activities; and

 (d) while on those premises, to inspect, and make copies of, any documents that concern those certification‑related activities.

4A.14  Conditions—producing information and documents

 (1) The Australian conformity assessment body will, if requested to do so by the Secretary, give the Secretary information, or produce to the Secretary documents, that concern certification‑related activities carried on by the body.

 (2) The information will be given, or the documents produced, within the period, of not less than 20 working days after the day the notice is given, specified in the notice.

 (3) The Australian conformity assessment body will have procedures, including a written agreement, in place with each of:

 (a) its clients; and

 (b) the contractors of the body that carry on certification‑related activities for the body;

that require the client or contractor to make available information or documents that the client or contractor has that is requested under subregulation (1).

4A.15  Conditions—reviews

  The Australian conformity assessment body will cooperate in any review by the Secretary of:

 (a) certification‑related activities carried on by the body; or

 (b) compliance with the conditions of the conformity assessment body determination.

4A.16  Conditions—record keeping

  The Australian conformity assessment body will keep:

 (a) the records required by Schedule 3AA; and

 (b) any other records necessary to demonstrate the body’s compliance, at all times while the determination is in effect, with the requirements of that Schedule.

4A.17  Conditions—Australian conformity assessment body certificates

Conformity assessment procedures

 (1) The Australian conformity assessment body will not issue an Australian conformity assessment body certificate unless the body is satisfied that an appropriate conformity assessment procedure has been applied to medical devices of the kind covered by the certificate.

Varying, suspending and revoking certificates

 (2) If the Australian conformity assessment body:

 (a) issues an Australian conformity assessment body certificate to a manufacturer; and

 (b) ceases to be satisfied that an appropriate conformity assessment procedure has been applied to medical devices of the kind covered by the certificate;

the body will:

 (c) vary, suspend or revoke the certificate; or

 (d) give to the manufacturer a written notice stating that the body will vary, suspend or revoke the certificate if the manufacturer does not, within a specified period, take the action necessary to satisfy the body that an appropriate conformity assessment procedure has been applied to the devices.

 (3) A period specified in a notice under paragraph (2)(d) must be appropriate.

 (4) The Australian conformity assessment body will vary, suspend or revoke an Australian conformity assessment body certificate if:

 (a) the body gave a notice to a manufacturer under paragraph (2)(d) in relation to the certificate; and

 (b) at the end of the period specified in the notice, the body is not satisfied that an appropriate conformity assessment procedure has been applied to medical devices of the kind covered by the certificate.

Notifying Secretary of changes to certificates and other matters

 (5) The Australian conformity assessment body will notify the Secretary within 10 working days if the body:

 (a) decides not to issue an Australian conformity assessment body certificate because the body is not satisfied as mentioned in subregulation (1); or

 (b) suspends or revokes an Australian conformity assessment body certificate; or

 (c) varies an Australian conformity assessment body certificate in the circumstances mentioned in subregulation (2) or (4); or

 (d) becomes aware of a matter of significant concern relating to the safety of a medical device to which an Australian conformity assessment body certificate issued by the body applies.

4A.18  Conditions—clients

Notifying clients if determination varied or suspended

 (1) The Australian conformity assessment body will notify its clients within 10 working days if the conformity assessment body determination is varied or suspended.

Agreements with successor Australian conformity assessment bodies

 (2) If a client of the Australian conformity assessment body (the old body) informs the old body that the client plans:

 (a) to cease to be a client of the old body; and

 (b) to become a client of another Australian conformity assessment body (the new body);

the old body will enter into an agreement with the new body that deals appropriately with the transfer from the old body to the new body of responsibility for carrying on certification‑related activities for the client.

Enquiries before accepting applications for certification

 (3) Before the Australian conformity assessment body accepts an application from a manufacturer to issue an Australian conformity assessment body certificate in relation to a kind of medical device, the body will make reasonable enquiries as to whether the manufacturer has applied to another Australian conformity assessment body to issue an Australian conformity assessment body certificate in relation to that kind of device.

Subdivision B—Conditions specified in conformity assessment body determinations

4A.19  Conditions specified in determinations

 (1) A conformity assessment body determination is subject to any conditions specified in the determination under subregulation 4A.7(5) or 4A.28(1).

Note: See sections 41MN and 41MNA of the Act for offences and civil penalty provisions that apply to breaching a condition of a conformity assessment body determination.

 (2) A condition imposed under subregulation 4A.7(5) or 4A.28(1) is in addition to the conditions imposed under Subdivision A of this Division.

Division 4A.4—Suspension of conformity assessment body determinations

4A.20  Suspension of determinations

 (1) The Secretary may, by written notice given to an Australian conformity assessment body, suspend the body’s conformity assessment body determination if the Secretary is satisfied that:

 (a) it is likely that there are grounds for revoking the determination under regulation 4A.27; and

 (b) it is likely that the body will, within the period of the suspension, be able to take action such that it will no longer be likely that there are grounds for revoking the determination.

 (2) The notice must specify the period of the suspension. The period:

 (a) must not exceed 12 months; and

 (b) must not begin before the notice is given to the body.

Note: The period of the suspension may be extended once under regulation 4A.22.

4A.21  Notice of proposed suspension

 (1) However, before suspending a conformity assessment body determination, the Secretary must:

 (a) notify the Australian conformity assessment body in writing that the Secretary proposes the suspension and set out the reasons for it; and

 (b) give the body a reasonable opportunity to make submissions to the Secretary in relation to the proposed suspension.

 (2) The Secretary must not make a decision relating to the proposed suspension until the Secretary has had regard to any submissions the body makes under paragraph (1)(b).

4A.22  Duration of suspension

 (1) The suspension takes effect on the day specified for the purpose in the notice, which must be at least 20 working days after the notice is given to the Australian conformity assessment body.

 (2) The suspension has effect until:

 (a) the Secretary revokes it under regulation 4A.23; or

 (b) the end of:

 (i) the period specified in the notice under subregulation 4A.20(2); or

 (ii) if the period is extended under subregulation (3) of this regulation—the period as so extended.

Note 1: The conditions to which the determination is subject continue during the suspension: see subsection 41EWA(7A) of the Act.

Note 2: Unless a suspension of a conformity assessment body determination has been revoked, the determination is automatically revoked at the end of the period of the suspension: see regulation 4A.25.

 (3) The Secretary may, by written notice given to the body, extend the period specified in the notice under subregulation 4A.20(2) by a further specified period not exceeding 12 months if the Australian conformity assessment body shows that it has taken steps to address the grounds for revoking the determination under regulation 4A.27.

 (4) Only one extension of the period of the suspension may be made.

4A.23  Revocation of suspension

 (1) The Secretary must revoke the suspension if the Secretary is satisfied that:

 (a) the grounds on which the conformity assessment body determination was suspended no longer apply; and

 (b) there are no other grounds for suspending the determination.

 (2) The Secretary’s power to revoke the suspension may be exercised:

 (a) if the Australian conformity assessment body applies in writing to the Secretary; or

 (b) on the Secretary’s own initiative.

 (3) After revoking the suspension, the Secretary must, within 20 working days after the revocation, give written notice of the revocation to the Australian conformity assessment body.

 (4) If the Secretary decides, after an application is made under paragraph (2)(a), not to revoke the suspension, the Secretary must:

 (a) notify the applicant in writing of his or her decision within 20 working days after the decision is made; and

 (b) state in the notice the reasons for the decision.

4A.24  Powers of revocation of determinations unaffected

 (1) This Division does not affect the Secretary’s powers to revoke a conformity assessment body determination under Division 4A.5.

 (2) To the extent that a suspension under this Division relates to a conformity assessment body determination to which such a revocation relates, the suspension ceases to have effect.

Division 4A.5—Revocation of conformity assessment body determinations

4A.25  Automatic revocation of determinations

 (1) The Secretary must, by written notice given to an Australian conformity assessment body, revoke the body’s conformity assessment body determination if:

 (a) the determination has been suspended under Division 4A.4; and

 (b) the period of the suspension under paragraph 4A.22(2)(b) ends before the suspension is revoked under regulation 4A.23.

 (2) The revocation takes effect at the end of the period mentioned in paragraph (1)(b) of this regulation.

4A.26  Immediate revocation of determinations

 (1) The Secretary may, by written notice given to an Australian conformity assessment body, revoke the body’s conformity assessment body determination if:

 (a) the body applies in writing to the Secretary; or

 (b) the body notifies the Secretary, as mentioned in subregulation 4A.12(2), that the body plans to cease carrying on certification‑related activities completely.

 (2) The revocation takes effect on the day specified for the purpose in the notice given by the Secretary.

 (3) If paragraph (1)(b) applies, the day specified in the notice given by the Secretary must be the day the Australian conformity assessment body notified the Secretary was the day the body planned to cease carrying on certification‑related activities.

4A.27  Revocation of determinations after notice of proposed revocation

 (1) The Secretary may, by written notice given to an Australian conformity assessment body, revoke the body’s conformity assessment body determination if:

 (a) the body refuses or fails to comply with a condition to which the determination is subject; or

 (b) at least one of the following persons:

 (i) the body;

 (ii) a person (a manager) who makes, or participates in making, decisions that affect the whole, or a substantial part, of the body’s affairs;

 (iii) a major interest holder of the body;

  has:

 (iv) been convicted of an offence against the Act or a corresponding State law; or

 (v) been convicted of an offence against a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or

 (vi) been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of the Act or a corresponding State law; or

 (vii) been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or

 (viii) breached a condition of a conformity assessment body determination; or

 (ix) had a conformity assessment body determination in respect of the person suspended or revoked; or

 (x) been a manager, or a major interest holder, of a body corporate in respect of which subparagraph (iv), (v), (vi), (vii), (viii) or (ix) applies, if the conduct resulting in that subparagraph applying occurred when the person was a manager or major interest holder of the body corporate.

 (2) A reference in paragraph (1)(b) to a person convicted of an offence includes a reference to a person in respect of whom an order has been made relating to the offence under:

 (a) section 19B of the Crimes Act 1914; or

 (b) a corresponding provision of a law of a State or Territory.

Note: Section 19B of the Crimes Act 1914 empowers a court that has found a person to have committed an offence to take action without proceeding to record a conviction.

 (3) Nothing in this regulation affects the operation of Part VIIC of the Crimes Act 1914 (which includes provisions that, in certain circumstances, relieve persons from the requirement to disclose spent convictions and require persons aware of such convictions to disregard them).

Notice of proposed revocation

 (4) Before revoking a conformity assessment body determination under this regulation, the Secretary must:

 (a) notify the Australian conformity assessment body in writing that the Secretary proposes the revocation and set out the reasons for it; and

 (b) give the body a reasonable opportunity to make submissions to the Secretary in relation to the proposed revocation.

 (5) The Secretary must not make a decision relating to the proposed revocation until the Secretary has had regard to any submissions the body makes under paragraph (4)(b).

When revocation takes effect

 (6) A revocation under this regulation takes effect on the day specified for the purpose in the notice given to the Australian conformity assessment body under subregulation (1).

 (7) The day specified must not be earlier than the day the notice is given to the body.

Division 4A.6—Variation of conformity assessment body determinations

4A.28  Imposing, varying or removing conditions

 (1) The Secretary may, by written notice given to an Australian conformity assessment body, vary the body’s conformity assessment body determination to:

 (a) impose new conditions on the determination; or

 (b) vary or remove existing conditions imposed on the determination under subregulation 4A.7(5) or this regulation.

 (2) The Secretary’s power under subregulation (1) may be exercised:

 (a) if the Australian conformity assessment body applies in writing to the Secretary; or

 (b) on the Secretary’s own initiative.

When imposition, variation or removal takes effect

 (3) An imposition or variation of a condition under this regulation takes effect on the day specified for the purpose in the notice.

 (4) The day specified in the notice under subregulation (3) must be at least 20 working days after the notice is given to the body, unless the body:

 (a) applied for the imposition or variation; and

 (b) has agreed to an earlier day.

 (5) A removal of a condition under this regulation takes effect on the day specified in the notice.

 (6) The day specified in the notice under subregulation (5) must be at least 20 working days after the notice is given to the body, unless the body has agreed to an earlier day.

 (7) For the purposes of subregulations (4) and (6), the earlier day must not be earlier than the day the notice is given to the body.

4A.29  Limiting determinations

 (1) The Secretary may, by written notice given to an Australian conformity assessment body, vary the body’s conformity assessment body determination to limit, or further limit, the determination as mentioned in paragraph 4A.7(4)(b).

 (2) The Secretary’s power under subregulation (1) of this regulation may be exercised:

 (a) if the Australian conformity assessment body applies in writing to the Secretary; or

 (b) on the Secretary’s own initiative.

 (3) A variation under this regulation takes effect on the day specified for the purpose in the notice.

 (4) The day specified in the notice under subregulation (3) must be at least 20 working days after the notice is given to the body, unless the body:

 (a) applied for the variation; and

 (b) has agreed to an earlier day.

 (5) For the purposes of subregulation (4), the earlier day must not be earlier than the day the notice is given to the body.

4A.30  Notice of proposed variation

 (1) Before varying a conformity assessment body determination under this Division, the Secretary must:

 (a) notify the Australian conformity assessment body in writing that the Secretary proposes the variation and set out the reasons for it; and

 (b) give the body a reasonable opportunity to make submissions to the Secretary in relation to the proposed variation.

 (2) The Secretary must not make a decision relating to the proposed variation until the Secretary has had regard to any submissions the body makes under paragraph (1)(b).

 (3) This regulation does not apply if the body applied for the variation.

Division 4A.7—Australian conformity assessment body certificates

4A.31  Content of Australian conformity assessment body certificates

  For the purposes of subsection 41EWB(2) of the Act, the information is all of the following:

 (a) the name and address of the body issuing the certificate;

 (b) the body’s ACN (within the meaning of the Corporations Act 2001);

 (c) the unique identification number assigned to the body under subsection 41EWA(4A) of the Act;

 (d) a unique identification number for the certificate;

 (e) the day on which the certificate is issued;

 (f) the name and address of the manufacturer of the medical devices;

 (g) the conformity assessment procedures applied to the medical devices by the manufacturer;

 (h) if the certificate covers a medical device to which paragraph 1.6(a), (b) or (c) applies—the unique product identifier given to the device by the manufacturer;

 (i) if the certificate is varied—the day and details of the variation;

 (j) if one or more Australian conformity assessment body certificates have previously been issued in respect of the medical devices by the body—the information covered by paragraphs (a) to (i) in relation to each of those certificates.

3  Subregulation 5.3(2)

After “certificate”, insert “, or an Australian conformity assessment body certificate,”.

4  Subregulation 7.2(1B)

Repeal the subregulation.

5  Before regulation 9.1

Insert:

Division 9.1—Fees

6  After regulation 9.1

Insert:

Division 9.2—Conformity assessment body determination assessment fees

9.1A  Purposes of this Division

  This Division is made for the purposes of paragraph 41EWA(3)(g) of the Act.

9.1B  Conformity assessment body determination assessment fees

 (1) A fee is payable in relation to the assessment of an application for a conformity assessment body determination mentioned in column 2 of item 1.4D, 1.4E or 1.4F in Part 1 of Schedule 5.

 (2) Subject to regulation 9.1C, the amount of the fee is the amount mentioned in column 4 of that item.

 (3) The fee is payable by the applicant.

 (4) Subject to regulation 9.1D, the fee is due and payable in full on the day specified under subregulation (5) of this regulation.

 (5) For the purposes of subregulation (4), the Secretary may give the applicant a written notice specifying when the fee is due and payable in full.

9.1C  Conformity assessment body determination assessment fees—abridged assessment

  If the Secretary considers that he or she has sufficient information to allow assessment of an application for a conformity assessment body determination to be abridged:

 (a) the Secretary may decide to conduct an abridged assessment of the application; and

 (b) if the Secretary so decides—the Secretary may reduce the amount of the conformity assessment body determination assessment fee for assessment of the application.

9.1D  Payment of conformity assessment body determination assessment fees by instalments

 (1) The Secretary may approve, in relation to an application (the relevant application) for a conformity assessment body determination, the payment of a conformity assessment body determination assessment fee by instalments if:

 (a) the applicant for the determination has applied in writing to pay the amount by instalments; and

 (b) the amount payable exceeds $10,000; and

 (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if the amount is paid before the commencement of the assessment of the relevant application; and

 (d) any information or material required under subregulation (3) has been given to the Secretary.

 (2) An application under subregulation (1) must:

 (a) state the reasons why paying the full amount of the fee before the assessment of the relevant application commences would cause financial hardship to the applicant; and

 (b) have with it documents or other material in support of the application.

 (3) The Secretary may reasonably require information or material in addition to the documents or material mentioned in paragraph (2)(b).

 (4) If the Secretary approves an application for payment by instalments:

 (a) half of the fee is due for payment before the commencement of the assessment of the relevant application; and

 (b) one‑quarter of the fee is due for payment at the end of one month after the last day when the amount referred to in paragraph (a) may be paid; and

 (c) the remaining one‑quarter of the fee is due for payment:

 (i) if the relevant application is withdrawn—when the relevant application is withdrawn; and

 (ii) in any other case—when the applicant is notified of the Secretary’s decision in respect of the relevant application under regulation 4A.7 or 4A.9.

 (5) If the Secretary receives an application for payment by instalments, the Secretary must:

 (a) within 30 days of receiving the application and any information or material required under subregulation (3), give notice, in writing, to the applicant stating whether the application has been approved; and

 (b) if the application is approved—include with the notice information about the amount of each instalment and when it is due for payment.

 (6) If:

 (a) the Secretary approves an application for payment by instalments; and

 (b) any amount of the instalment payable by the applicant is not paid when it becomes due for payment;

the balance of the fee becomes due for payment.

9.1E  Recovery of conformity assessment body determination assessment fees

  A conformity assessment body determination assessment fee may be recovered by the Commonwealth as a debt due to the Commonwealth.

9.1F  Refund of conformity assessment body determination assessment fees if applications withdrawn

 (1) The applicant for a conformity assessment body determination may apply to the Secretary, in writing, for a refund of the conformity assessment body determination assessment fee for the application if the applicant withdraws the application:

 (a) after all or part of the fee becomes due and payable; and

 (b) before the Secretary makes a decision on the application under subregulation 4A.6(1).

 (2) Within 20 working days after receiving the application, the Secretary must:

 (a) decide whether to refund any of the fee; and

 (b) if so—the amount of the fee to be refunded.

 (3) To avoid doubt, the applicant is not entitled to a refund of the application fee for the application.

Division 9.3—Assessment fees

7  After regulation 10.6A

Insert:

10.6B  Forms or manners—software requirements

  If a provision of these Regulations provides for the approval or specification of a form or manner of giving an application, notice or other document, the approval or specification may require or permit the application, notice or other document to be given in accordance with specified software requirements:

 (a) on a specified kind of data processing device; or

 (b) by way of a specified kind of electronic transmission.

8  Subregulation 10.7(1) (after paragraph (ab) of the definition of initial decision)

Insert:

 (aba) the following provisions (about conformity assessment body determinations):

 (i) subregulation 4A.6(1);

 (ii) subparagraph 4A.7(3)(a)(i) or (ii);

 (iii) subregulation 4A.7(5);

 (iv) regulation 4A.20;

 (v) subregulation 4A.22(3);

 (vi) subregulation 4A.23(1);

 (vii) subregulation 4A.26(1);

 (viii) subregulation 4A.27(1);

 (ix) subregulation 4A.28(1);

 (x) subregulation 4A.29(1);

9  Subregulation 10.7(1) (after paragraph (ad) of the definition of initial decision)

Insert:

 (ae) the following provisions (about conformity assessment body determination assessment fees):

 (i) regulation 9.1C;

 (ii) subregulation 9.1D(1);

 (iii) subregulation 9.1F(2);

10  After Schedule 3

Insert:

Schedule 3AA—Requirements for Australian conformity assessment bodies

Note: See Part 4A.

1  Purpose of this Schedule

  This Schedule sets out requirements for the purposes of making, suspending, revoking or varying a conformity assessment body determination under Part 4A of these Regulations.

2  EU Regulations

 (1) The requirements are:

 (a) to the extent the determination covers medical devices that are not IVD medical devices—the requirements of the EU medical devices regulation, as modified by clauses 3, 4 and 5 of this Schedule; and

 (b) to the extent the determination covers IVD medical devices—the requirements of the EU IVD regulation, as modified by clauses 3, 4 and 6 of this Schedule.

 (2) The EU medical devices regulation is Annex VII to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, as in force from time to time.

 (3) The EU IVD regulation is Annex VII to Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices, as in force from time to time.

3  Modifications of EU Regulations—general

 (1) For the purposes of subclause 2(1), the EU medical devices regulation and the EU IVD regulation (the EU regulations) are taken to be modified as set out in this clause.

General modifications

 (2) A reference in the EU regulations to a term mentioned in column 1 of an item of the following table is taken to be a reference to the term mentioned in column 2 of that item.

 (3) Subclause (2) has effect subject to subclause (6) and clauses 5 and 6.

 (4) For the purposes of the EU regulations:

 (a) an activity is taken to be designated, in relation to an Australian conformity assessment body, if the activity relates to conformity assessment procedures covered by the body’s conformity assessment body determination; and

 (b) a device is taken to be designated, in relation to an Australian conformity assessment body, if the device is covered by the body’s conformity assessment body determination.

 (5) A reference in the EU regulations to CS is disregarded.

Note: CS is short for common specifications.

Modifications of specific provisions

 (6) Each EU regulation is taken to be modified in the following ways:

 (a) the following provisions are disregarded:

 (i) Sections 1.1.1, 1.2.6, 1.2.8, 1.6.1, 3.2.1 and 4.5.6;

 (ii) the words “unless liability is assumed by the Member State in question in accordance with national law or that Member State is directly responsible for their conformity assessment” in Section 1.4.1;

 (iii) the words “and the results of the coordination activities referred to in Section 1.6” in Section 3.5.2;

 (iv) the sentence “Refusals or withdrawals of applications shall be notified to the electronic system referred to in Article 57 and shall be accessible to other notified bodies.” in Section 4.3;

 (v) the words “and to perform unannounced on site audits” in Section 4.5.1;

 (vi) the words “as referred to in Annexes II and III” in point (a) of Section 4.5.2;

 (vii) all the words after “resultant decision” in Section 4.8;

 (viii) the words “EU technical documentation assessment certificates or EU” in Section 4.11;

 (b) in Section 3.1.1, the words “performance and safety of devices” are replaced with the words “compliance with the essential principles”;

 (c) in Section 4.3, a reference to an authorised representative is taken to be a reference to an applicant authorised by the manufacturer;

 (d) in Section 4.5.1, a reference to relevant Annexes is taken to be a reference to Schedule 3 to these Regulations;

 (e)  in Section 4.5.3, the words “For assessment of the technical documentation conducted in accordance with Chapter II of Annex IX” are replaced with the words “For the assessment of compliance of manufacturers with clause 1.6 of Schedule 3 to these Regulations”;

 (f) in Section 4.10:

 (i) the words “unannounced on‑site audits of manufacturers and, where applicable, subcontractors” are replaced with the words “the audit of subcontractors”; and

 (ii) the words “laid down in the relevant Annexes” are replaced with the words “for a quality management system set out in Schedule 3 for the conformity assessment procedure applied by the manufacturer”; and

 (iii) the words “summary of safety and performance” are replaced with the words “evidence of compliance with the essential principles”;

 (g) in Section 4.11, the word “reviews” (wherever occurring) is replaced with the word “assessments”.

4  Additional requirements

 (1) For the purposes of subclause 2(1), the EU medical devices regulation and the EU IVD regulation (the EU regulations) are taken to include the requirements mentioned in this clause.

Independence and impartiality

 (2) Section 1.2 of each EU regulation includes a requirement that an Australian conformity assessment body will take action:

 (a) to respond to any threats to its impartiality; and

 (b) to ensure that all internal or external personnel or committees who could influence the body’s certification‑related activities will:

 (i) act impartially; and

 (ii) not allow commercial, financial or other pressures to compromise impartiality.

Liability

 (3) Section 1.4 of each EU regulation includes a requirement that an Australian conformity assessment body will:

 (a) document a justification for the cover and overall financial value of the liability insurance mentioned in that Section, including:

 (i) the types of medical devices and conformity assessment procedures in relation to which the body carries on certification‑related activities; and

 (ii) the locations at which those activities are carried on; and

 (iii) the patient risk profile of the devices; and

 (iv) the compliance risk profiles of the manufacturing activities in relation to which the body carries on certification‑related activities; and

 (b) give this justification to the body’s liability insurer, and document having done so.

Process requirements

 (4) Section 4 of each EU regulation includes a requirement that an Australian conformity assessment body will have documented procedures in place that cover the following in relation to the body’s certification‑related activities:

 (a) assigning internal or external personnel to activities on the basis of their documented competences;

 (b) following up corrections and corrective actions by manufacturers in relation to nonconformities identified during audits or assessments.

5  Additional modifications of EU medical devices regulations

 (1) For the purposes of subclause 2(1), the EU medical devices regulation is taken to be modified as set out in this clause.

 (2) A reference in the EU medical devices regulation to PMCF is disregarded.

Note: PMCF is short for post‑market clinical follow‑up.

 (3) The following provisions of the EU medical devices regulation are disregarded:

 (a) the last dash point of Section 1.1.6;

 (b) the eighth dash point of Section 4.5.1;

 (c) the words “referred to in Annexes II and III” in point (b) of Section 4.5.3;

 (d) the words “as specified in Section 15 of Annex XI” in point (d) of Section 4.5.3;

 (e) the words “any substance incorporated in or utilised for the manufacturing of a device and being subject to the specific procedures in accordance with Section 4.5.6” in Section 4.9.

 (4) A reference in the EU medical devices regulation to Section 4.5.6 is taken to be a reference to Section 4.5.5.

6  Modifications of EU IVD regulations

 (1) For the purposes of subclause 2(1), the EU IVD regulation is taken to be modified as set out in this clause.

 (2) A reference in the EU IVD regulation to companion diagnostics or PMPF is disregarded.

Note: PMPF is short for post‑market performance follow‑up.

 (3) The EU IVD regulation is modified in the following ways:

 (a) the following provisions are disregarded:

 (i) point (g) of Section 1.1.6;

 (ii) the seventh dash point of Section 4.5.1;

 (iii) the words “, and taking account of Sections 4.5.4. and 4.5.5” in section 4.5.3;

 (iv) the words “, taking account of Sections 4.5.4. and 4.5.5,” in section 4.5.3;

 (v) the subsection headed Verification by examination and testing of every product batch in Section 4.5.3;

 (vi) Sections 4.5.4 and 4.5.5;

 (vii) the words “any substance incorporated in or utilised for the manufacturing of a device and being subject to the specific procedures in accordance with Section 4.5.5” in Section 4.9;

 (b) the words “self and near patient testing” in Section 3.2.2 are replaced with the words “self‑testing and point of care testing”.

7  Expressions used in modifications

  To avoid doubt, an expression used in a modification of the EU medical devices regulation or EU IVD regulation made by this Schedule has the same meaning in that modification as it does elsewhere in these Regulations.

11  Part 1 of Schedule 5 (after table item 1.4)

Insert:

12  Dictionary

Insert:

client of an Australian conformity assessment body means a manufacturer with whom the body has an agreement under which the body will carry on certification‑related activities, including issuing Australian conformity assessment body certificates to the manufacturer.

conformity assessment body determination assessment fee means a fee payable under regulation 9.1B for assessing an application for a conformity assessment body determination.

EU IVD regulation has the meaning given by subclause 2(3) of Schedule 3AA.

EU medical devices regulation has the meaning given by subclause 2(2) of Schedule 3AA.

full designation conformity assessment body determination means a conformity assessment body determination that is of general application.

partial designation conformity assessment body determination (full QMS) means a conformity assessment body determination that is not:

 (a) a full designation conformity assessment body determination; or

 (b) a partial designation conformity assessment body determination (partial QMS or partial devices).

partial designation conformity assessment body determination (partial QMS or partial devices) means a conformity assessment body determination that:

 (a) is not a full designation conformity assessment body determination; and

 (b) covers:

 (i) the conformity assessment procedures set out in clause 1.6 or Part 2 of Schedule 3 (whether or not the determination also covers other procedures); or

 (ii) a Class III or Class AIMD medical device (whether or not the determination also covers other medical devices).

Part 2—Amendments consequential on the Therapeutic Goods Amendment (2017 Measures No. 1) Act 2018

Therapeutic Goods (Medical Devices) Regulations 2002

13  Clause 1.1 of Schedule 3

After “Secretary” (wherever occurring), insert “or an Australian conformity assessment body”.

14  At the end of paragraph 1.3(1)(b) of Schedule 3

Add “or an Australian conformity assessment body”.

15  Paragraph 1.3(2)(g) of Schedule 3

Repeal the paragraph, substitute:

 (g) an undertaking by the manufacturer:

 (i) if the manufacturer arranged for assessment of the system by the Secretary—to notify the Secretary, or the person in relation to whom the kind of device is included in the Register, of any information of the kind mentioned in paragraph 1.4(3A)(a) or (b) that the manufacturer becomes aware of in relation to the kind of medical device; or

 (ii) if the manufacturer arranged for assessment of the system by an Australian conformity assessment body—to notify the body, or the person in relation to whom the kind of device is included in the Register, of any information of the kind mentioned in paragraph 1.4(3A)(a) or (b) that the manufacturer becomes aware of in relation to the kind of medical device.

16  Paragraph 1.4(3)(c) of Schedule 3

Repeal the paragraph, substitute:

 (c) to:

 (i) if the manufacturer arranged for assessment of the system under clause 1.3 by the Secretary—notify the Secretary, or the person in relation to whom the kind of device is included in the Register, as soon as practicable after becoming aware of information referred to in subclause (3A); or

 (ii) if the manufacturer arranged for assessment of the system under clause 1.3 by an Australian conformity assessment body—notify the body, or the person in relation to whom the kind of device is included in the Register, as soon as practicable after becoming aware of information referred to in subclause (3A).

17  After subclause 1.4(3) of Schedule 3

Insert:

 (3A) For the purposes of subparagraphs (3)(c)(i) and (ii), the information is the following:

 (a) information relating to:

 (i) any malfunction or deterioration in the characteristics or performance of the kind of device; or

 (ii) any inadequacy in the design, production, labelling or instructions for use of the kind of device, or in the advertising material for the kind of device; or

 (iii) any use in accordance with, or contrary to, the use intended by the manufacturer of the kind of device;

  that might lead, or might have led, to the death of a patient or a user of the device, or to a serious deterioration in his or her state of health;

 (b) information relating to any technical or medical reason for a malfunction or deterioration of a kind mentioned in subparagraph (a)(i) that has led the manufacturer to take steps to recall devices of that kind that have been distributed.

18  Paragraph 1.5(2)(a) of Schedule 3

After “Secretary”, insert “or an Australian conformity assessment body”.

19  Paragraph 1.5(2)(b) of Schedule 3

After “Secretary”, insert “or the Australian conformity assessment body”.

20  Subclause 1.6(2) of Schedule 3

After “Secretary”, insert “or an Australian conformity assessment body”.

21  Subclause 1.6(4) of Schedule 3

After “examination by the Secretary”, insert “or an Australian conformity assessment body”.

22  Paragraph 1.6(4)(a) of Schedule 3

After “Secretary”, insert “or an Australian conformity assessment body”.

23  Paragraph 1.6(4)(b) of Schedule 3

After “Secretary”, insert “or the Australian conformity assessment body”.

24  Paragraph 1.8(2)(f) of Schedule 3

Repeal the paragraph, substitute:

 (f) state the identification number of the conformity assessment certificate, or of the Australian conformity assessment body certificate, issued in relation to the system or the kind of medical devices to which the system has been applied; and

25  At the end of paragraph 1.9(1)(g) of Schedule 3

Add “or an Australian conformity assessment body”.

26  Clause 2.1 of Schedule 3

After “Secretary”, insert “or an Australian conformity assessment body”.

27  At the end of subclause 2.3(1) of Schedule 3

Add “or an Australian conformity assessment body”.

28  Subclauses 2.3(4) and (5) of Schedule 3

After “Secretary” (wherever occurring), insert “or the Australian conformity assessment body”.

29  Subclause 2.4(1) of Schedule 3

After “Secretary”, insert “or an Australian conformity assessment body”.

30  Paragraph 2.4(2)(a) of Schedule 3

After “Secretary”, insert “or an Australian conformity assessment body”.

31  Paragraph 2.4(2)(b) of Schedule 3

After “Secretary”, insert “or the Australian conformity assessment body”.

32  At the end of paragraph 2.5(1)(c) of Schedule 3

Add “or an Australian conformity assessment body”.

33  Paragraph 3.1(a) of Schedule 3

After “Secretary”, insert “or an Australian conformity assessment body”.

34  Subclause 3.3(1) of Schedule 3

After “by the Secretary”, insert “or an Australian conformity assessment body”.

35  Paragraph 3.3(2)(e) of Schedule 3

Repeal the paragraph, substitute:

 (e) an undertaking by the manufacturer:

 (i) if the manufacturer arranged for examination and testing by the Secretary—to notify the Secretary, or the person in relation to whom the kind of device is included in the Register, of any information of the kind mentioned in paragraph 3.4(2A)(a) or (b) that the manufacturer becomes aware of in relation to the kind of medical device; or

 (ii) if the manufacturer arranged for examination and testing by an Australian conformity assessment body—to notify the body, or the person in relation to whom the kind of device is included in the Register, of any information of the kind mentioned in paragraph 3.4(2A)(a) or (b) that the manufacturer becomes aware of in relation to the kind of medical device;

36  Subclause 3.3(3) of Schedule 3

After “to the Secretary”, insert “or the Australian conformity assessment body”.

37  Subparagraphs 3.3(3)(a)(ii) and (b)(ii) of Schedule 3

After “Secretary”, insert “or the Australian conformity assessment body”.

38  Paragraph 3.4(2)(c) of Schedule 3

Repeal the paragraph, substitute:

 (c) to:

 (i) if the manufacturer arranged for examination and testing under clause 3.3 by the Secretary—notify the Secretary, or the person in relation to whom the kind of device is included in the Register, as soon as practicable after becoming aware of information referred to in subclause (2A); or

 (ii) if the manufacturer arranged for examination and testing under clause 3.3 by an Australian conformity assessment body—notify the body, or the person in relation to whom the kind of device is included in the Register, as soon as practicable after becoming aware of information referred to in subclause (2A).

39  After subclause 3.4(2) of Schedule 3

Insert:

 (2A) For the purposes of subparagraphs (2)(c)(i) and (ii), the information is the following:

 (a) information relating to:

 (i) any malfunction or deterioration in the characteristics or performance of the kind of device; or

 (ii) any inadequacy in the design, production, labelling, instructions for use or advertising materials of the kind of device; or

 (iii) any use in accordance with, or contrary to, the use intended by the manufacturer of the kind of device;

  that might lead, or might have led, to the death of a patient or a user of the device, or to a serious deterioration in his or her state of health;

 (b) information relating to any technical or medical reason for a malfunction or deterioration of a kind mentioned in subparagraph (a)(i) that has led the manufacturer to take steps to recall devices of that kind that have been distributed.

40  Subparagraph 3.5(2)(e)(i) of Schedule 3

Repeal the subparagraph, substitute:

 (i) state the identification number of the conformity assessment certificate, or of the Australian conformity assessment body certificate, issued in relation to the approved type; and

41  At the end of paragraph 3.6(1)(c) of Schedule 3

Add “or an Australian conformity assessment body”.

42  Clause 4.1 of Schedule 3

After “Secretary” (wherever occurring), insert “or an Australian conformity assessment body”.

43  At the end of paragraph 4.3(1)(b) of Schedule 3

Add “or an Australian conformity assessment body”.

44  Paragraph 4.3(2)(i) of Schedule 3

Repeal the paragraph, substitute:

 (i) an undertaking by the manufacturer:

 (i) if the manufacturer arranged for assessment of the system by the Secretary—to notify the Secretary, or the person in relation to whom the kind of device is included in the Register, of any information of the kind mentioned in paragraph 4.4(3A)(a) or (b) that the manufacturer becomes aware of in relation to the kind of medical device; or

 (ii) if the manufacturer arranged for assessment of the system by an Australian conformity assessment body—to notify the body, or the person in relation to whom the kind of device is included in the Register, of any information of the kind mentioned in paragraph 4.4(3A)(a) or (b) that the manufacturer becomes aware of in relation to the kind of medical device.

45  Paragraph 4.4(3)(c) of Schedule 3

Repeal the paragraph, substitute:

 (c) to:

 (i) if the manufacturer arranged for assessment of the system under clause 4.3 by the Secretary—notify the Secretary, or the person in relation to whom the kind of device is included in the Register, as soon as practicable after becoming aware of information referred to in subclause (3A); or

 (ii) if the manufacturer arranged for assessment of the system under clause 4.3 by an Australian conformity assessment body—notify the body, or the person in relation to whom the kind of device is included in the Register, as soon as practicable after becoming aware of information referred to in subclause (3A).

46  After subclause 4.4(3) of Schedule 3

Insert:

 (3A) For the purposes of subparagraphs (3)(c)(i) and (ii), the information is the following:

 (a) information relating to:

 (i) any malfunction or deterioration in the characteristics or performance of the kind of device; or

 (ii) any inadequacy in the design, production, labelling, instructions for use or advertising materials of the kind of device; or

 (iii) any use in accordance with, or contrary to, the use intended by the manufacturer of the kind of device;

  that might lead, or might have led, to the death of a patient or a user of the device, or to a serious deterioration in his or her state of health;

 (b) information relating to any technical or medical reason for a malfunction or deterioration of a kind mentioned in subparagraph (a)(i) that has led the manufacturer to take steps to recall devices of that kind that have been distributed.

47  Paragraph 4.5(2)(a) of Schedule 3

After “Secretary”, insert “or an Australian conformity assessment body”.

48  Paragraph 4.5(2)(b) of Schedule 3

After “Secretary”, insert “or the Australian conformity assessment body”.

49  Paragraph 4.7(2)(f) of Schedule 3

Repeal the paragraph, substitute:

 (f) state the identification number of the conformity assessment certificate, or of the Australian conformity assessment body certificate, issued in relation to the system or the kind of medical devices to which the system has been applied; and

50  At the end of paragraph 4.8(1)(d) of Schedule 3

Add “or an Australian conformity assessment body”.

51  Clause 5.1 of Schedule 3

After “Secretary” (wherever occurring), insert “or an Australian conformity assessment body”.

52  At the end of paragraph 5.3(1)(b) of Schedule 3

Add “or an Australian conformity assessment body”.

53  Paragraph 5.3(2)(i) of Schedule 3

Repeal the paragraph, substitute:

 (i) an undertaking by the manufacturer:

 (i) if the manufacturer arranged for assessment of the system by the Secretary—to notify the Secretary, or the person in relation to whom the kind of device is included in the Register, of any information of the kind mentioned in paragraph 5.4(3A)(a) or (b) that the manufacturer becomes aware of in relation to the kind of medical device; or

 (ii) if the manufacturer arranged for assessment of the system by an Australian conformity assessment body—to notify the body, or the person in relation to whom the kind of device is included in the Register, of any information of the kind mentioned in paragraph 5.4(3A)(a) or (b) that the manufacturer becomes aware of in relation to the kind of medical device.

54  Paragraph 5.4(3)(c) of Schedule 3

Repeal the paragraph, substitute:

 (c) to:

 (i) if the manufacturer arranged for assessment of the system under clause 5.3 by the Secretary—notify the Secretary, or the person in relation to whom the kind of device is included in the Register, as soon as practicable after becoming aware of information referred to in subclause (3A); or

 (ii) if the manufacturer arranged for assessment of the system under clause 5.3 by an Australian conformity assessment body—notify the body, or the person in relation to whom the kind of device is included in the Register, as soon as practicable after becoming aware of information referred to in subclause (3A).

55  After subclause 5.4(3) of Schedule 3

Insert:

 (3A) For the purposes of subparagraphs (3)(c)(i) and (ii), the information is the following:

 (a) information relating to:

 (i) any malfunction or deterioration in the characteristics or performance of the kind of device; or

 (ii) any inadequacy in the design, production, labelling, instructions for use or advertising materials of the kind of device; or

 (iii) any use in accordance with, or contrary to, the use intended by the manufacturer of the kind of device;

  that might lead, or might have led, to the death of a patient or a user of the device, or to a serious deterioration in his or her state of health;

 (b) information relating to any technical or medical reason for a malfunction or deterioration of a kind mentioned in subparagraph (a)(i) that has led the manufacturer to take steps to recall devices of that kind that have been distributed.

56  Paragraph 5.5(2)(a) of Schedule 3

After “Secretary”, insert “or an Australian conformity assessment body”.

57  Paragraph 5.5(2)(b) of Schedule 3

After “Secretary”, insert “or the Australian conformity assessment body”.

58  Paragraph 5.7(2)(g) of Schedule 3

Repeal the paragraph, substitute:

 (g) state the identification number of the conformity assessment certificate, or of the Australian conformity assessment body certificate, issued in relation to the system or the kind of medical devices to which the system has been applied; and

59  At the end of paragraph 5.8(1)(e) of Schedule 3

Add “or an Australian conformity assessment body”.

60  Paragraph 6.6(2)(h) of Schedule 3

Repeal the paragraph, substitute:

 (h) if the technical documentation applies to any of the following kinds of medical devices:

 (i) a Class IIa medical device;

 (ii) a Class 2 IVD medical device;

 (iii) a Class I medical device that the manufacturer intends to be supplied in a sterile state;

 (iv) a Class I medical device that has a measuring function;

  state the identification number of the conformity assessment certificate, or of the Australian conformity assessment body certificate, issued in relation to the kind of medical device, or the quality management system that has been applied to the kind of device, as a result of the application to the device of the conformity assessment procedures set out in Part 3, 4 or 5 of this Schedule; and

61  Paragraph 6(1)(c) of Schedule 3A

After “devices”, insert “and requirements, comparable to the conformity assessment procedures, were not applied to the devices”.

Schedule 4—Advertising

Part 1—Enforcement

Therapeutic Goods Regulations 1990

1  Paragraphs 5L(1)(d) and (e)

Repeal the paragraphs, substitute:

 (d) the advertisement does not comply with the Therapeutic Goods Advertising Code.

2  Regulation 6

Repeal the regulation.

3  At the end of regulation 6AA

Add:

 ; (c) Advisory Committee on Medical Devices;

 (d) Advisory Committee on Vaccines.

4  Regulation 6A

Repeal the regulation.

5  Regulation 7

Repeal the regulation, substitute:

7  Prescribed goods for advertising offence and civil penalty

  For the purposes of subsections 42DL(12) and 42DLB(9) of the Act, the therapeutic goods are the following:

 (a) therapeutic goods that are the subject of an approval or authority under section 19 of the Act;

 (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;

 (c) medicines covered by an exemption under subregulation 12A(1);

 (d) therapeutic goods specified in item 1 of Schedule 5;

 (e) therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A;

 (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;

 (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;

 (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;

 (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act.

7A  Publisher exception for civil penalty provisions

  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.

6  Regulation 8

Omit “the principles stated in subsections 4(1), (2), (3), (4), (5) and (6) of the Therapeutic Goods Advertising Code are specified”, substitute “subsections 4(1), (2), (3), (4), (5) and (6) of the Therapeutic Goods Advertising Code are prescribed”.

7  Regulation 8A

Repeal the regulation.

8  Division 5 of Part 2

Repeal the Division.

9  Subregulation 47(3)

Omit “or subregulation 9(3)”.

10  Subregulation 48(1) (paragraph (a) of the definition of initial decision)

Repeal the paragraph.

11  In the appropriate position in Division 7 of Part 9

Insert:

62  Saving provision

  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.

Part 2—Removal of requirement for advertisements to be approved

Therapeutic Goods Regulations 1990

12  Regulation 2

Repeal the following definitions:

 (a) definition of ASMI;

 (b) definition of CHCA;

 (c) definition of designated therapeutic goods.

13  Division 2 of Part 2

Repeal the Division.

14  Subregulation 47(3)

Repeal the subregulation.

15  Subclause 1(1) of Schedule 9

Repeal the following definitions:

 (a) definition of broadcast media;

 (b) definition of regional area;

 (c) definition of regional station;

 (d) definition of specified media.

16  Clause 3 of Schedule 9 (table items 17 and 17A)

Repeal the items.

Part 3—Other amendments

Therapeutic Goods Regulations 1990

17  Regulation 2 (definition of Complaints Resolution Panel)

Repeal the definition.

18  Subregulation 5L(2)

Repeal the subregulation.

19  Subregulation 5L(3)

Omit “or (2)”.

20  Subregulations 5M(3) and (5)

Repeal the subregulations.

21  Subregulation 5N(2)

Repeal the subregulation.

22  Subregulation 5Q(5A)

Repeal the subregulation.

23  Divisions 2 and 3 of Part 6

Repeal the Divisions.

Schedule 5—Infringement notices

Therapeutic Goods Regulations 1990

1  Part 7A

Repeal the Part.

2  Subregulation 47(1A)

Repeal the subregulation.

3  Schedule 15

Repeal the Schedule.

Schedule 6—Preliminary assessment of applications

Therapeutic Goods (Medical Devices) Regulations 2002

1  Subregulation 5.4C(2)

Omit “effective”.

2  Subregulation 5.4C(2)

After “Register”, insert “that passes preliminary assessment”.

3  Subregulation 5.4C(2) (note)

Repeal the note, substitute:

Note: See subsection 41FDB(3) of the Act for when an application passes preliminary assessment.

4  Subparagraph 5.4D(1)(a)(ii)

Omit “is not effective”, substitute “does not pass preliminary assessment”.

5  Subregulation 5.4D(1) (note)

Repeal the note, substitute:

Note: See subsection 41FDB(3) of the Act for when an application passes preliminary assessment.

6  Subregulation 11.1(1) (note at the end of the definition of listed or registered transitional device)

Repeal the note.

7  Subregulations 11.8(2), 11.17(2) and 11.18(2) (note)

Repeal the note.

8  Part 1 of Schedule 5 (cell at table item 1.5, column headed “Provision of Act or these Regulations”)

Repeal the cell, substitute: