Therapeutic Goods (Medical Devices - Application Form for Priority Applicant Determinations) Approval 2020

I, Meryl Clarke, as delegate of the Secretary of the Department of Health, make the following approval.

Dated 9 December 2020

Meryl Clarke
Assistant Secretary
Medical Devices Authorisation Branch
Health Products Regulation Group
Department of Health

1. Name

This instrument is the Therapeutic Goods (Medical Devices—Application Form for Priority Applicant Determinations) Approval 2020.

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Note: This table relates only to the provisions of this instrument as originally made.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 4.3B(2) and 5.4A(2) of the Therapeutic Goods (Medical Devices) Regulations 2002.

4. Definitions

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

1. medical device

Note 2: A number of expressions used in this instrument are defined in the Dictionary at the end of the Regulations, including the following:

1. Conformity Assessment (priority applicant) determination; and
2. medical devices (priority applicant) determination.

In this instrument:

Act means Therapeutic Goods Act 1989.

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

5. Approved form

1. The approved form for an application under subregulation 4.3B(1) of the Regulations for a Conformity Assessment (priority applicant) determination in relation to a medical device is the form titled Application for priority applicant determination - medical devices published on the Therapeutic Goods Administration's website.
2. The approved form for an application under subregulation 5.4A(1) of the Regulations for a medical devices (priority applicant) determination in relation to a medical device is the form titled Application for priority applicant determination - medical devices published on the Therapeutic Goods Administration's website.