Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:3:p33
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 3 (pt 33/43)
Character Range: 424776–427617

to the design or production of such devices.
 (3) If any inspections or tests are carried out by an authorised person in relation to the manufacturer's premises, or medical devices produced by the manufacturer, the manufacturer may ask the authorised person to give to the manufacturer a report stating the findings of the inspections or tests.

6A.4  Post‑marketing system
 (1) The manufacturer of a Class 1, 2 or 3 in‑house IVD medical device must establish, and keep up‑to‑date, a post‑marketing system for use for the device.
 (2) The post‑marketing system must require the manufacturer of the device to:
 (a) systematically review experience gained in the post‑production phase for the device; and
 (b) implement appropriate means to apply any necessary corrective action for the design or production of the device; and
 (c) notify the Secretary as soon as practicable after becoming aware of information relating to any of the following that might lead, or might have led, to the death of a patient or a user of the device, or to a serious deterioration in his or her state of health:
 (i) any malfunction or deterioration in the characteristics or performance of the device;
 (ii) any inadequacy in the design, production, labelling, instructions for use or advertising materials of the device;
 (iii) any use in accordance with, or contrary to, the use intended by the manufacturer of the device.

Part 6B—Procedures applying to Class 4 in‑house IVD medical devices

6B.1  Overview
  The conformity assessment procedures set out in this Part provide for the manufacturer of a Class 4 in‑house IVD medical device to do the following:
 (a) implement a quality management system for the design, production, packaging, labelling and final inspection of that kind of device;
 (b) prepare technical documentation in relation to that kind of device;
 (c) establish and keep up‑to‑date a post‑market monitoring, reporting and corrective action system;
 (d) make a declaration of conformity in relation to that kind of device;
 (e) prepare and keep records in relation to these procedures;
 (f) notify the Secretary of the manufacture of certain Class 4 in‑house IVD medical devices.

6B.2  References to kinds of medical devices
  A reference in this Part to a kind of medical device includes a reference to an individual medical device.

6B.3  Procedures
 (1) The manufacturer of a Class 4 in‑house IVD medical device must implement a quality management system for the design, production, packaging, labelling and final inspection of that kind of device.
 (2) If the kind of device is used in relation to the manufacture of blood, blood components and plasma derivatives, human cell and tissue based therapeutic goods, either:
 (a) the manufacturer must:
 (i) satisfy the requirements in the Australian Code of Good Manufacturing Practice