Commonwealth Consolidated Regulations

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THERAPEUTIC GOODS (MEDICAL DEVICES) REGULATIONS 2002 - REG 4A.6

Assessing applications

  (1)   If an application is made in accordance with regulation   4A.2 for a conformity assessment body determination in respect of an Australian corporation, the Secretary must decide whether to make the conformity assessment body determination.

Conditions and criteria for making determinations

  (2)   The Secretary must not decide to make the determination unless he or she is satisfied that it is likely that the Australian corporation will be able to comply with the requirements of Schedule   3AA.

  (3)   In deciding whether to make the conformity assessment body determination, the Secretary must also consider:

  (a)   whether at least one of the following persons:

  (i)   the Australian corporation;

  (ii)   a person (a manager ) who makes, or participates in making, decisions that affect the whole, or a substantial part, of the Australian corporation's affairs;

  (iii)   a major interest holder of the Australian corporation;

    has, within the 10 years immediately before the application:

  (iv)   been convicted of an offence against the Act or a corresponding State law; or

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

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

  (vii)   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

  (viii)   breached a condition of a conformity assessment body determination; or

  (ix)   had a conformity assessment body determination in respect of the person suspended or revoked; or

  (x)   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 years, if the conduct resulting in that subparagraph applying occurred when the person was a manager or major interest holder of the body corporate; and

  (b)   any other relevant matter.

  (4)   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:

  (a)   section   19B of the Crimes Act 1914 ; or

  (b)   a corresponding provision of a law of a State or Territory.

Note:   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.

  (5)   Nothing in this regulation affects the operation of Part   VIIC of the Crimes Act 1914 (which includes provisions that, in certain circumstances, relieve persons from the requirement to disclose spent convictions and require persons aware of such convictions to disregard them).

  (6)   Subregulation (2) and paragraph   (3)(a) do not limit paragraph   (3)(b).



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