Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 15A

The general rule

             (1)  This Part does not apply to a medical device unless this section provides otherwise.

Previously registered or listed devices

             (2)  If a medical device is registered goods or listed goods before the commencement of this section, this Part continues to apply to the device unless the registration or listing is cancelled.

Note:          A registration or listing can be cancelled under section 30, or can be taken to be cancelled under section 9B.

Pending applications

             (3)  This Part continues to apply to a medical device if:

                     (a)  before the commencement of this section, an application was made under Part 3 for registration or listing of therapeutic goods that include that medical device; and

                     (b)  immediately before that commencement, the application was not yet finally determined; and

                     (c)  the application has not been, and is not, withdrawn either before or after that commencement.

However, this Part ceases to apply to the device if, having been registered goods or listed goods, the registration or listing is cancelled.

             (4)  For the purposes of paragraph (3)(b), an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.

Applications made within 2 years relating to certain medical devices

             (5)  This Part applies to a medical device if:

                     (a)  regulations made for the purposes of this section specified either:

                              (i)  the medical device classification applying to the kind of medical device that includes that device; or

                             (ii)  medical devices of that kind; and

                     (b)  during the period of 2 years after the commencement of this section, an application was made under Part 3‑2 for registration or listing of therapeutic goods that include that medical device.

However, this Part ceases to apply to the device if, having been registered goods or listed goods, the registration or listing is cancelled.

Note:          Medical devices that are registered or listed because of this subsection are taken to be cancelled 2 years after Chapter 4 commences, or before then if medical devices of that kind are included in the Register under Chapter 4: see subsection 9B(1).

Medical devices that are exempt goods

             (6)  This Part applies to a medical device, during the period of 2 years after the commencement of this section, if the device is exempt goods.

Existing approvals under section 19

             (7)  This Part continues to apply to a medical device if:

                     (a)  an approval or authorisation in force under section 19 applies to the device; and

                     (b)  that approval or authorisation was in force immediately before the commencement of this section.

New approvals under section 19

             (8)  This Part applies to a medical device if:

                     (a)  subsection (7) does not apply to the device; and

                     (b)  during the period of 2 years after the commencement of this section, an approval is granted or an authorisation is given under section 19 that applies to the device.

However, this subsection does not apply after the end of that period.