THERAPEUTIC GOODS ACT 1989 - SECT 41ET Revocation of conformity assessment certificates after notice of proposed revocation

THERAPEUTIC GOODS ACT 1989 - SECT 41ET

  (1)   The Secretary may, by written notice given to the person in relation to whom a conformity assessment certificate is issued, revoke the certificate if:

  (a)   the conformity assessment procedures have not been applied to medical devices of a kind to which the certificate applies; or

  (b)   the manufacturer in relation to whom the certificate is issued refuses or fails to comply with a condition to which the certificate is subject; or

  (c)   the Secretary gives to the person a notice under section   41JA that requires the person to give to the Secretary information or documents and the person fails to comply with that notice within a further 10 working days from the day specified in that notice; or

  (d)   the manufacturer in respect of whom the certificate is issued no longer manufactures any of the kinds of medical devices to which the certificate applies; or

  (e)   at least one of the following persons:

  (i)   the person (the holder ) in relation to whom the certificate is issued;

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

  (iii)   if the holder is a body corporate--a major interest holder of the body corporate;

    has:

  (iv)   been convicted of an offence against this 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 this 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 document; or

  (ix)   had a conformity assessment document 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, if the conduct resulting in that subparagraph applying occurred when the person was a manager or major interest holder of the body corporate; or

  (f)   any other circumstances prescribed by the regulations for the purposes of this paragraph exist.

  (1A)   A reference in paragraph   (1)(e) 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.

  (1B)   Paragraph   (1)(e) does not limit paragraph   (1)(f).

  (2)   However, before revoking the certificate, the Secretary must:

  (a)   inform the person in writing that the Secretary proposes the revocation and set out the reasons for it; and

  (b)   give the person a reasonable opportunity to make submissions to the Secretary in relation to the proposed revocation.

  (3)   The Secretary is not to make a decision relating to the proposed revocation until the Secretary has had regard to any submissions the person makes under paragraph   (2)(b).

  (4)   Nothing in this section 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).