Therapeutic Goods (Medical Devices) Amendment (Auditing Applications) Regulation 2014

Select Legislative Instrument No. 38, 2014

I, Quentin Bryce AC CVO, Governor‑General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following regulation under the Therapeutic Goods Act 1989.

Dated 25 March 2014

Quentin Bryce

Governor‑General

By Her Excellency’s Command

Fiona Nash

Assistant Minister for Health

Contents

1 Name of regulation

2 Commencement

3 Authority

4 Schedule(s)

Schedule 1—Amendments

Therapeutic Goods (Medical Devices) Regulations 2002

1  Name of regulation

  This regulation is the Therapeutic Goods (Medical Devices) Amendment (Auditing Applications) Regulation 2014.

2  Commencement

  This regulation commences on the day after it is registered.

3  Authority

  This regulation is made under the Therapeutic Goods Act 1989.

4  Schedule(s)

  Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.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

Therapeutic Goods (Medical Devices) Regulations 2002

1  Regulation 5.3 (heading)

Repeal the heading, substitute:

5.3  Selecting applications for auditing (Act s 41FH)

2  At the end of regulation 5.3

Add:

 (3) For paragraph 41FH(3)(b) of the Act, a period of 60 working days is prescribed in relation to an application mentioned in subregulation 11.1(3) that is made before 1 July 2014.

3  Subregulation 11.1(4)

Omit “Regulation 5.3”, substitute “Subregulation 5.3(1)”.