Therapeutic Goods Act 1989

The Secretary may grant a written approval to a person for:

the importation into Australia; or

the exportation from Australia; or

the supply in Australia;

for use in the treatment of another person; or

for use solely for experimental purposes in humans.

For variation of an approval for use of the kind referred to in paragraph (1)(e), see subsection (8).

An approval for use of the kind referred to in paragraph (1)(d) must not be granted to a person unless the person is a health practitioner.

The approval may be given subject to conditions specified in the approval, including a condition relating to charging for medical devices of the kinds in question.

Breach of the conditions may be an offence: see subsections 41MN(9), (9A) and (9B).

In addition, the regulations may prescribe conditions that apply to a person’s approval to use specified kinds of medical devices solely for experimental purposes in humans. The conditions may relate to one or more of the following:

the preconditions on another person’s use of devices of those kinds for those purposes;

the principles to be followed in another person’s use of devices of those kinds for those purposes;

the monitoring of another person’s use, and the results of that use, of devices of those kinds for those purposes;

the circumstances in which that other person must cease using devices of those kinds for those purposes.

An application to use specified medical devices in the treatment of another person must be in a form (if any) approved, in writing, by the Secretary and be accompanied by any information about the devices that is required by the Secretary.

An application to use specified kinds of medical devices solely for experimental purposes in humans must:

be in a form (if any) approved, in writing, by the Secretary; and

be accompanied by any information about the kinds of devices that is required by the Secretary; and

be accompanied by the prescribed fee.

The Secretary must:

consider any application under this section; and

assess any information submitted with the application; and

notify the applicant, within 20 working days of making the decision:

of the decision; and

in the case of a decision not to grant the approval—of the reasons for the decision.

The use by a person for experimental purposes in humans of specified kinds of medical devices that are the subject of an approval granted to someone else under paragraph (1)(e) is subject to the conditions (if any) specified in the regulations relating to one or more of the following:

the preconditions on the use of devices of those kinds for those purposes;

the principles to be followed in the use of devices of those kinds for those purposes;

the monitoring of the use, and the results of the use, of devices of those kinds for those purposes;

the circumstances in which the person must cease the use of devices of those kinds for those purposes.

Breach of the conditions may be an offence: see subsections 41MN(9), (9A) and (9B).

If:

the Secretary grants an approval to a person under subsection (1) for use of the kind referred to in paragraph (1)(e); and

the person requests the Secretary to do either or both of the following:

vary the medical device or kind of medical device specified in the approval;

vary the conditions imposed under subsection (2) on the approval; and

the request is in a form (if any) approved, in writing, by the Secretary; and

the request is accompanied by such information relating to the medical device or kind of medical device as is required by the Secretary; and

the request is accompanied by the fee prescribed by the regulations;

The Secretary must notify the person making the request under subsection (8) of:

the Secretary’s decision on the request; and

for a decision to vary the approval in a way that is different than the variation requested or a decision to refuse to vary the approval—the reasons for the decision.

A variation under subsection (8) takes effect at the time the Secretary notifies the person under subsection (9) of the variation.