Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:2:p19
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 2 (pt 19/40)
Character Range: 84502–87555

the Secretary, give the Secretary information, or produce to the Secretary documents, that concern certification‑related activities carried on by the body.
 (2) The information will be given, or the documents produced, within the period, of not less than 20 working days after the day the notice is given, specified in the notice.
 (3) The Australian conformity assessment body will have procedures, including a written agreement, in place with each of:
 (a) its clients; and
 (b) the contractors of the body that carry on certification‑related activities for the body;
that require the client or contractor to make available information or documents that the client or contractor has that is requested under subregulation (1).

4A.15  Conditions—reviews
  The Australian conformity assessment body will cooperate in any review by the Secretary of:
 (a) certification‑related activities carried on by the body; or
 (b) compliance with the conditions of the conformity assessment body determination.

4A.16  Conditions—record keeping
  The Australian conformity assessment body will keep:
 (a) the records required by Schedule 3AA; and
 (b) any other records necessary to demonstrate the body's compliance, at all times while the determination is in effect, with the requirements of that Schedule.

4A.17  Conditions—Australian conformity assessment body certificates

Conformity assessment procedures
 (1) The Australian conformity assessment body will not issue an Australian conformity assessment body certificate unless the body is satisfied that an appropriate conformity assessment procedure has been applied to medical devices of the kind covered by the certificate.

Varying, suspending and revoking certificates
 (2) If the Australian conformity assessment body:
 (a) issues an Australian conformity assessment body certificate to a manufacturer; and
 (b) ceases to be satisfied that an appropriate conformity assessment procedure has been applied to medical devices of the kind covered by the certificate;
the body will:
 (c) vary, suspend or revoke the certificate; or
 (d) give to the manufacturer a written notice stating that the body will vary, suspend or revoke the certificate if the manufacturer does not, within a specified period, take the action necessary to satisfy the body that an appropriate conformity assessment procedure has been applied to the devices.
 (3) A period specified in a notice under paragraph (2)(d) must be appropriate.
 (4) The Australian conformity assessment body will vary, suspend or revoke an Australian conformity assessment body certificate if:
 (a) the body gave a notice to a manufacturer under paragraph (2)(d) in relation to the certificate; and
 (b) at the end of the period specified in the notice, the body is not satisfied that an appropriate conformity assessment procedure has been applied to medical devices of the kind covered by the certificate.

Notifying Secretary of changes to certificates and other matters
 (5) The Australian conformity assessment body will notify the Secretary within