Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:3:p20
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 3 (pt 20/43)
Character Range: 391611–394388

to lot numbers, batches or serial numbers, or by specifying the kinds of medical devices or the times of manufacture); and
 (e) for a kind of device in relation to which the type examination procedures have been applied—state that:
 (i) the type examination procedures have been applied to the kind of device; and
 (ii) the kind of device conforms to the approved type; and
 (f) state the identification number of the conformity assessment certificate, or of the Australian conformity assessment body certificate, issued in relation to the system or the kind of medical devices to which the system has been applied; and
 (g) state that each kind of medical device to which the system has been applied complies with the applicable provisions of the essential principles, the classification rules and the production quality assurance procedures before being supplied; and
 (h) give details of any conformity assessment standard that has been applied to the system; and
 (i) be signed by a person authorised by the manufacturer; and
 (j) set out the name and position of the person signing the declaration; and
 (k) state the date when the declaration is signed.

4.8  Records
 (1) The manufacturer of a kind of medical device to which a quality management system that has been assessed under clause 4.3 of this Schedule has been applied must keep the following records in relation to the system and the kind of device:
 (a) the documentation mentioned in subclause 4.4(5) of this Schedule;
 (b) details of any changes made to the system and to the information and documentation required under subclause 4.5(3) of this Schedule;
 (c) for a Class 4 IVD medical device, Class 3 IVD medical device, Class III medical device or Class IIb medical device—the declaration of conformity under clause 4.7 of this Schedule;
 (d) any notice, report, certificate or other document in relation to the system issued to the manufacturer by the Secretary or an Australian conformity assessment body.
 (2) The manufacturer must keep the records for at least 5 years after the manufacture of the last medical device to which the quality management system was applied.
 (3) On request from the Secretary, the manufacturer must make the records available to the Secretary.

Part 5—Product quality assurance procedures

5.1  Overview
  The conformity assessment procedures set out in this Part provide for the manufacturer of a kind of medical device:
 (a) to:
 (i) implement a product quality management system for the final inspection and testing of the kind of device; and
 (ii) arrange for assessment of the system by the Secretary or an Australian conformity assessment body; and
 (b) to allow the Secretary or an Australian conformity assessment body to monitor the operation of, and carry out