Therapeutic Goods Act 1989

The Minister may, by writing, exempt specified kinds of medical devices from the operation of the following:

Division 1 of Part 4‑2 (essential principles);

Division 1 of Part 4‑3 (conformity assessment procedures);

Part 4‑4 (conformity assessment certificates);

Part 4‑5 (including medical devices in the Register).

The Minister may exempt devices under subsection (1) only if the Minister is satisfied of the matter in subsection (2) or (2A).

The matter in this subsection is that in the national interest, the exemption should be made so that:

the devices may be stockpiled as quickly as possible in order to create a preparedness to deal with a potential threat to public health that may be caused by a possible future emergency; or

the devices can be made available urgently in Australia in order to deal with an actual threat to public health caused by an emergency that has occurred.

The matter in this subsection is that:

a national emergency declaration is in force; and

either of the following apply:

the exemption should be made so that the devices may be stockpiled to deal with a potential threat to public health that may be caused by the emergency to which the national emergency declaration relates;

the exemption should be made so that the devices can be made available urgently in Australia in order to deal with an actual threat to public health caused by the emergency to which the national emergency declaration relates; and

the Minister is satisfied that the exemption is in the national interest.

An exemption under subsection (1) comes into force:

on the day the exemption is made; or

on a later day specified in the exemption.

An exemption under subsection (1) remains in force for the period specified in the exemption, unless revoked earlier.

Section 41GU deals with variation and revocation of the exemption.

An exemption under subsection (1) ceases to have effect in relation to a particular kind of medical device when that kind of medical device becomes included in the Register under Part 4‑5.

An exemption under subsection (1) is not a legislative instrument.

For the purposes of this Act, disregard section 41BE in working out the kinds of medical devices covered by an exemption under subsection (1) of this section.