Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:3:p5
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 3 (pt 5/43)
Character Range: 353304–356008

the equipment) used, or to be used, to carry out the tests or trials;
 (f) the system for reviewing experience gained in the post‑production phase in relation to the kind of medical device to which the quality management system has been applied, and the means by which any necessary corrective action will be applied in relation to the design or production of such devices;
 (g) whether a conformity assessment standard has been applied to the system and, if no conformity assessment standard, or part only of a conformity assessment standard, has been applied to the system—the solutions adopted to ensure that the system complies with subclause (2).

1.5  Changes to quality management system or kinds of medical device to which system is to be applied
 (1) This clause applies to the manufacturer of a kind of medical device if:
 (a) the manufacturer has implemented, and had assessed under clause 1.3 of this Schedule, a quality management system that is to be applied to the kind of device; and
 (b) after assessment, the manufacturer plans to make:
 (i) a substantial change to the system; or
 (ii) a change to the kinds of medical devices to which the system is to be applied.
 (2) The manufacturer must:
 (a) notify the Secretary or an Australian conformity assessment body, in writing, of the proposed change; and
 (b) arrange for assessment of the change by the Secretary or the Australian conformity assessment body to verify whether the system, as changed, meets the requirements of clause 1.4 of this Schedule.
 (3) For the purpose of enabling the assessment to be carried out, the manufacturer must have available, in writing, details of any consequential changes to the information and documentation required under subclause 1.3(2) of this Schedule in relation to the system or kinds of devices.
 (4) After any change to the quality management system, the manufacturer must ensure that the changed system continues to meet the requirements of clause 1.4 of this Schedule.

1.6  Examination of design of Class 4 IVD medical device, Class 4 in‑house IVD medical device or Class III medical device
 (1) This clause applies to the manufacturer of a Class 4 IVD medical device, a Class 4 in‑house IVD medical device or a Class III medical device, to which the quality management system that is to be assessed under clause 1.3 is to be applied.
 (2) For the purpose of assessing whether the kind of medical device complies with the applicable provisions of the essential principles, the manufacturer of the device must arrange for examination by the Secretary or an Australian conformity assessment body of the design of the kind of device.
 (3) For the purpose of enabling the examination to be