Therapeutic Goods (Application Form for Conformity Assessment Body Determination) Approval 2021

I, Tracey Duffy, as delegate of the Secretary of the Department of Health, make the following approval.

Dated 1 July 2021

Tracey Duffy
Assistant Secretary
Medical Devices and Product Quality Division
Health Products Regulation Group
Department of Health

1. Name

This instrument is the Therapeutic Goods (Application Form for Conformity Assessment Body Determination) Approval 2021.

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Note: This table relates only to the provisions of this instrument as originally made.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 subregulations 4A.2(4) of the Therapeutic Goods (Medical Devices) Regulations 2002.

4. Definitions

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

1. conformity assessment body determination;
2. Secretary.

In this instrument:

Act means Therapeutic Goods Act 1989.

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

Therapeutic Goods Administration has the same meaning as in the Therapeutic Goods Regulations 1990.

5. Approved forms

For the purposes of subparagraphs 4A.2(2)(a)(ii) and (iii) of the MD Regulations, the approved form for making an application to the Secretary for a conformity assessment body determination is the online application form accessed via the Application for Determination of Australian Conformity Assessment Bodies link on the Australian Conformity Assessment Bodies page under the Medical Devices and IVDs heading in the Industry tab on the Therapeutic Goods Administration website.