Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:3:p12
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 3 (pt 12/43)
Character Range: 371169–373977

to the kind of medical device;
 (f) for a kind of device in relation to which the type examination procedures have been applied—evidence that the device conforms to the approved type and a copy of the technical documentation required under subclause 2.3(3) of the type examination procedures for the approved type;
 (g) for a kind of device to which the declaration of conformity (not requiring assessment by Secretary) procedures have been applied—a copy of the technical documentation prepared under clause 6.4 of those procedures for that kind of device.
 (3) The manufacturer must make available to the Secretary or the Australian conformity assessment body for examination and testing:
 (a) for a kind of device in relation to which the type examination procedures have been applied:
 (i) each medical device that is to be verified in relation to the approved type; or
 (ii) each medical device selected by the Secretary or the Australian conformity assessment body on a statistical basis from a uniform batch of devices that are to be verified in relation to the approved type; and
 (b) for a kind of device to which the declaration of conformity (not requiring assessment by Secretary) procedures have been applied:
 (i) each medical device of that kind to which those procedures have been applied; or
 (ii) each medical device selected by the Secretary or the Australian conformity assessment body on a statistical basis from a uniform batch of devices of that kind to which those procedures have been applied.

3.4  Requirements of manufacturing system
 (1) The manufacturer of a medical device must ensure that:
 (a) for a kind of device in relation to which the type examination procedures have been applied—the process used to manufacture the device results in the device conforming to the approved type; and
 (b) for a kind of device to which the declaration of conformity (not requiring assessment by Secretary) procedures have been applied—the process used to manufacture the device results in the device being in accordance with the technical documentation prepared under clause 6.4 of those procedures for that kind of device.
 (2) The manufacturer of a medical device of a kind mentioned in subclause (1) must ensure that the process used to manufacture the device includes post‑marketing requirements under which the manufacturer is required:
 (a) to systematically review experience gained in the post‑production phase in relation to medical devices of that kind; and
 (b) to implement appropriate means to apply any necessary corrective action in relation to the design or production of such devices; and
 (c) to:
 (i) if the manufacturer arranged for examination and testing under clause 3.3 by the Secretary—notify the Secretary, or the person in relation to whom the kind of device is