Therapeutic Goods (Medical Device Standard—Therapeutic Vaping Devices) Order 2023

I, Anthony Lawler, as delegate of the Minister for Health and Aged Care, make the following order.

Dated 15 December 2023

Professor Anthony Lawler

Deputy Secretary
Health Products Regulation Group
Department of Health and Aged Care

Contents

1  Name

2  Commencement

3  Authority

4  Definitions

5  Standard

6  Application

7  Medical device standard

1  Name

  This instrument is the Therapeutic Goods (Medical Device Standard—Therapeutic Vaping Devices) Order 2023.

2  Commencement

Note: This table relates only to the provisions of this instrument as originally made.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.

3  Authority

  This instrument is made under subsection 41CB(1) of the Therapeutic Goods Act 1989.

4  Definitions

Note 1: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:

(a) essential principles;

(b) medical device standard;

(c) therapeutic goods.

  In this instrument:

Act means the Therapeutic Goods Act 1989.

EU Directive 2014/40/EU means EU Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive 2001/37/EC, as in force or existing from time to time.

IAF accredited organisation means an organisation that is accredited to undertake certification for compliance with ISO 9001 or ISO 13485 (or both) by an accreditation body member that is a signatory to the Multilateral Recognition Arrangement of the International Accreditation Forum, Inc., otherwise known as the IAF MLA.

ISO 13485 means International Standard ISO 13485, Medical devices—Quality management systems—Requirements for regulatory purposes, issued by the International Organization for Standardization, as in force or existing from time to time.

Note: ISO 13485 is published at www.iso.org.

ISO 9001 means International Standard ISO 9001, Quality Management Systems, issued by the International Organization for Standardization, as in force or existing from time to time.

Note: ISO 9001 is published at www.iso.org.

notified body means a body that:

 (a) has been designated by a member state of the European Union, and notified to the European Commission; or

 (b) has been approved or designated by the United Kingdom Medicines & Healthcare products Regulatory Agency;

to assess the conformity of medical devices.

Regulations means the Therapeutic Goods (Medical Devices) Regulations 2002.

therapeutic vaping device has the same meaning as in the Regulations.

therapeutic vaping device accessory has the same meaning as in the Regulations.

5  Standard

  This instrument constitutes a medical device standard for therapeutic vaping devices and therapeutic vaping device accessories.

6  Application

  This instrument applies to a therapeutic vaping device or a therapeutic vaping device accessory that:

 (a) was excluded under item 16 of the table in Schedule 1 to the Therapeutic Goods (Excluded Goods) Determination 2018, as in force immediately before the commencement of the Therapeutic Goods (Excluded Goods) Amendment (Vaping) Order 2023; and

 (b) is intended by the person under whose name the device is or is to be supplied, only to administer or contain a therapeutic vaping substance whose only indications are use for smoking cessation or the management of nicotine dependence; and

 (c) is imported or manufactured on or after 1 March 2024.

Note: The Therapeutic Goods (Excluded Goods) Determination 2018 is a legislative instrument published on the Federal Register of Legislation at www.legislation.gov.au.

7  Medical device standard

 (1) The matters specified in Schedule 1 constitute a medical device standard for therapeutic vaping devices and therapeutic vaping device accessories.

 (2) Therapeutic vaping devices and therapeutic vaping device accessories that comply with the standard in subsection 7(1) are to be treated as complying with all parts of the essential principles in Schedule 1 to the Regulations.

Schedule 1—Medical device standard for therapeutic vaping devices

Note: See section 7.