Document ID: chunk:federal_register_of_legislation:C2007C00652:clause:1_41et
Version: federal_register_of_legislation:C2007C00652
Segment Type: clause
Provision Reference: sch 1 cl 41ET
Character Range: 57674–59229

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 relating to:
 (i) a kind of medical device; or
 (ii) a quality management system to which the certificate applies;
  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.

 (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).