Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:3:p26
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 3 (pt 26/43)
Character Range: 406862–409709

the following records in relation to the system and the kind of device:
 (a) the documentation mentioned in subclause 5.4(5) of this Schedule;
 (b) details of any changes made to the system and to the information and documentation required under subclause 5.5(3) of this Schedule;
 (c) details of any changes made to the kinds of medical devices to which the system was applied;
 (d) for a Class IIb medical device—the declaration of conformity under clause 5.7 of this Schedule;
 (e) 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 6—Declaration of conformity (not requiring assessment by Secretary) procedures

6.1  Overview
  The conformity assessment procedures set out in this Part provide for the manufacturer of a kind of medical device:
 (a) to prepare technical documentation in relation to the kind of device to enable assessment of the device; and
 (b) to make a declaration of conformity in relation to the kind of device; and
 (c) to establish and keep up‑to‑date a post‑market monitoring, reporting and corrective action system.
Note: See Division 3.2 in relation to the kinds of medical devices to which these conformity assessment procedures may be applied.

6.2  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.

6.3  Implementation
 (1) The manufacturer of a medical device must prepare technical documentation in relation to the kind of device in a form that, if the Secretary decides to do so, would allow the Secretary to assess whether the device complies with the applicable provisions of the essential principles, the classification rules and these conformity assessment procedures.
 (2) For the purpose of enabling an assessment to be carried out, the manufacturer must have available, in writing, the following information and undertakings:
 (a) the name and business address of the manufacturer;
 (b) details of each manufacturing site where these conformity assessment procedures are to be applied;
 (c) all relevant information required to identify the kinds of medical devices to which these conformity assessment procedures are to be applied;
 (d) an undertaking by the manufacturer 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 subparagraph 6.5(2)(c)(i) or (ii) that the manufacturer becomes aware of in relation to a