Therapeutic Goods Act 1989

If the application is made in accordance with section 41EB, the Secretary must decide whether to issue the conformity assessment certificate.

In deciding whether to issue the certificate, the Secretary must consider some or all aspects of whether the conformity assessment procedures relating to one or more of the following have been applied to the medical device:

the application of quality management systems for the manufacture of medical devices;

the certification of compliance with the essential principles;

any other requirement of the conformity assessment procedures specified in regulations made for the purposes of this subsection.

In deciding whether to issue the certificate, the Secretary must also consider:

whether at least one of the following persons:

the applicant;

a person (a manager) who makes, or participates in making, decisions that affect the whole, or a substantial part, of the applicant’s affairs;

if the applicant is a body corporate—a major interest holder of the body corporate;

been convicted of an offence against this Act or a corresponding State law; or

been convicted of an offence against a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or

been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of this Act or a corresponding State law; or

been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or

breached a condition of a conformity assessment document; or

had a conformity assessment document suspended or revoked; or

been a manager, or a major interest holder, of a body corporate in respect of which subparagraph (iv), (v), (vi), (vii), (viii) or (ix) applies in that 10 year period, if the conduct resulting in that subparagraph applying occurred when the person was a manager or major interest holder of the body corporate; or

whether any other circumstances prescribed by the regulations for the purposes of this paragraph exist.

A reference in paragraph (3)(a) to a person convicted of an offence includes a reference to a person in respect of whom an order has been made relating to the offence under:

section 19B of the Crimes Act 1914; or

a corresponding provision of a law of a State or Territory.

Section 19B of the Crimes Act 1914 empowers a court that has found a person to have committed an offence to take action without proceeding to record a conviction.

Paragraph (3)(a) does not limit paragraph (3)(b).

The Secretary may, by written notice given to the applicant, require the applicant:

to deliver to the office to which the application was made a reasonable number of samples of the kind of medical device to which the application relates within the period, of not less than 14 days after the day the notice is given, specified in the notice; and

to do so in a manner specified in the notice.