Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:3:p16
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 3 (pt 16/43)
Character Range: 381378–384148

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;
 (h) 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;
 (i) an undertaking by the manufacturer:
 (i) if the manufacturer arranged for assessment of the system by the Secretary—to notify the Secretary, or the person in relation to whom the kind of device is included in the Register, of any information of the kind mentioned in paragraph 4.4(3A)(a) or (b) that the manufacturer becomes aware of in relation to the kind of medical device; or
 (ii) if the manufacturer arranged for assessment of the system by an Australian conformity assessment body—to notify the body, or the person in relation to whom the kind of device is included in the Register, of any information of the kind mentioned in paragraph 4.4(3A)(a) or (b) that the manufacturer becomes aware of in relation to the kind of medical device.

4.4  Requirements of production quality management system
 (1) A quality management system that is to be assessed under clause 4.3 must meet the requirements of this clause.
 (2) The system must be of a kind such that its application will ensure that:
 (a) each medical device to which the system is applied that is of a kind in relation to which the type examination procedures have been applied conforms to the approved type; and
 (b) each medical device to which the system is applied that is of a kind to which the declaration of conformity (not requiring assessment by Secretary) procedures are applied is in accordance with the technical documentation prepared under clause 6.4 of those procedures for the device.
 (3) The system must include post‑marketing requirements under which the manufacturer of a medical device to which the system is applied 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 assessment of the system under clause 4.3 by the Secretary—notify the Secretary, or the person in relation to whom the kind of device is included in the Register, as soon as practicable after becoming aware of information referred to in subclause (3A); or
 (ii) if the manufacturer arranged for assessment of the system under clause 4.3 by an Australian conformity assessment body—notify the