Therapeutic Goods Act 1989

The regulations may make provision for and in relation to empowering the Secretary to make conformity assessment body determinations.

A conformity assessment body determination is a determination that a specified Australian corporation is an Australian conformity assessment body for the purposes of this Act.

The regulations may make provision for and in relation to the following matters:

applications for conformity assessment body determinations;

the approval by the Secretary of a form for such an application;

information that must accompany such an application;

the application fee for such an application;

the lapsing of such an application;

the assessment by the Secretary of whether a conformity assessment body determination should be made in response to such an application;

the assessment fee for such an assessment;

the duration of conformity assessment body determinations.

A conformity assessment body determination:

may be of general application; or

may be limited to either or both of the following:

one or more specified medical devices;

one or more specified conformity assessment procedures.

If under the regulations the Secretary makes a conformity assessment body determination, the Secretary must assign a unique identification number to the body.

The Secretary must publish a list of the Australian conformity assessment bodies on the Department’s website.

The Secretary may also publish on the Department’s website any information relating to Australian conformity assessment bodies and either to conformity assessment body determinations or to certification‑related activities of Australian conformity assessment bodies.

The regulations may provide that a conformity assessment body determination is subject to:

the conditions prescribed by the regulations; and

such other conditions (if any) as are specified in the determination.

See subsections 41MN(10) to (12) and 41MNA(3) for offences and a civil penalty for a breach of the conditions.

The following are examples of conditions that may be prescribed:

a condition that the body will allow an authorised person:

to enter, at any reasonable time, premises used by the body to carry on certification‑related activities; and

while on those premises, to inspect those premises and anything on those premises that concerns certification‑related activities carried on by the body; and

while on those premises, to make any still or moving image or any recording of those premises or anything on those premises that concerns certification‑related activities carried on by the body; and

while on those premises, to inspect, and make copies of, any documents that concern certification‑related activities carried on by the body;

a condition that the body will, if requested to do so by the Secretary, give the Secretary information, or produce to the Secretary documents, that concern certification‑related activities carried on by the body.

The regulations may make provision for and in relation to the effect on an Australian conformity assessment body certificate of the Australian conformity assessment body ceasing to carry on certification‑related activities.

Without limiting subsection (6A), regulations made for the purposes of that subsection may make provision in relation to a matter by conferring on the Secretary a power to make a decision of an administrative character.

The regulations may make provision for and in relation to empowering the Secretary to revoke, suspend or vary a conformity assessment body determination.

If under the regulations the Secretary suspends a conformity assessment body determination, the conditions referred to in subsection (5) continue during the suspension.

Subsections (3) to (7) do not limit subsection (1).

The express references in this section to the Secretary do not, by implication, prevent the regulations from empowering the Secretary to delegate any or all of the Secretary’s functions or powers under regulations made for the purposes of this section.

If a conformity assessment body determination is in force under the regulations, the determination must be published on the Department’s website.

A conformity assessment body determination made under the regulations is not a legislative instrument.

Subsection 33(3AB) of the Acts Interpretation Act 1901 does not apply to the specification of an Australian corporation in a conformity assessment body determination.

Subsection 33(3AB) of the Acts Interpretation Act 1901 deals with specification by class.