Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:2:p20
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 2 (pt 20/40)
Character Range: 87272–90359

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 10 working days if the body:
 (a) decides not to issue an Australian conformity assessment body certificate because the body is not satisfied as mentioned in subregulation (1); or
 (b) suspends or revokes an Australian conformity assessment body certificate; or
 (c) varies an Australian conformity assessment body certificate in the circumstances mentioned in subregulation (2) or (4); or
 (d) becomes aware of a matter of significant concern relating to the safety of a medical device to which an Australian conformity assessment body certificate issued by the body applies.

4A.18  Conditions—clients

Notifying clients if determination varied or suspended
 (1) The Australian conformity assessment body will notify its clients within 10 working days if the conformity assessment body determination is varied or suspended.

Agreements with successor Australian conformity assessment bodies
 (2) If a client of the Australian conformity assessment body (the old body) informs the old body that the client plans:
 (a) to cease to be a client of the old body; and
 (b) to become a client of another Australian conformity assessment body (the new body);
the old body will enter into an agreement with the new body that deals appropriately with the transfer from the old body to the new body of responsibility for carrying on certification‑related activities for the client.

Enquiries before accepting applications for certification
 (3) Before the Australian conformity assessment body accepts an application from a manufacturer to issue an Australian conformity assessment body certificate in relation to a kind of medical device, the body will make reasonable enquiries as to whether the manufacturer has applied to another Australian conformity assessment body to issue an Australian conformity assessment body certificate in relation to that kind of device.

Subdivision B—Conditions specified in conformity assessment body determinations

4A.19  Conditions specified in determinations
 (1) A conformity assessment body determination is subject to any conditions specified in the determination under subregulation 4A.7(5) or 4A.28(1).
Note: See sections 41MN and 41MNA of the Act for offences and civil penalty provisions that apply to breaching a condition of a conformity assessment body determination.
 (2) A condition imposed under subregulation 4A.7(5) or 4A.28(1) is in addition to the conditions imposed under Subdivision A of this Division.

Division 4A.4—Suspension of conformity assessment body determinations

4A.20  Suspension of determinations
 (1) The Secretary may, by written notice given to an Australian conformity assessment body, suspend the body's conformity assessment body determination if the Secretary is satisfied that:
 (a) it is likely that there are grounds for revoking