Document ID: chunk:federal_register_of_legislation:C2024C00632:section:41et:p1
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 41ET (pt 1/2)
Character Range: 688606–691270

41ET  Revocation of conformity assessment certificates after notice of proposed revocation
 (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