Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:3:p22
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 3 (pt 22/43)
Character Range: 396692–399450

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 5.4(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 5.4(3A)(a) or (b) that the manufacturer becomes aware of in relation to the kind of medical device.

5.4  Requirements of product quality management system
 (1) A quality management system that is to be assessed under clause 5.3 must meet the requirements of this clause.
 (2) The system must be of a kind such that its application will ensure that each medical device, or representative sample of each batch of medical devices, is examined and tested to ensure that the device, or representative sample:
 (a) for a kind of device in relation to which the type examination procedures have been applied—conforms to the approved type; or
 (b) for a kind of device to which the declaration of conformity (not requiring assessment by Secretary) procedures have been 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 5.3 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 5.3 by an Australian conformity assessment body—notify the body, 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).
Note: See also paragraph 41FN(3)(d) and sections 41MP and 41MPA of the Act in relation to the requirement to give certain information about a medical device to the Secretary.
 (3A) For the