Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:3:p10
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 3 (pt 10/43)
Character Range: 365996–368809

assessment body, additional samples of the type.
 (5) If the type is intended by the manufacturer to be connected to another medical device, the manufacturer must, on request from the Secretary or the Australian conformity assessment body, make available to the Secretary or the Australian conformity assessment body, or arrange for the Secretary or the Australian conformity assessment body to have access to, a sample of the device.

2.4  Changes to design of medical device after examination
 (1) This clause applies if, after examination by the Secretary or an Australian conformity assessment body of a type, the manufacturer of the type plans to make a substantial change to the design, or intended performance, of the kind of medical device to which the type relates.
 (2) The manufacturer must:
 (a) notify the Secretary or an Australian conformity assessment body, in writing, of the proposed change; and
 (b) arrange for examination of the change by the Secretary or the Australian conformity assessment body to verify whether the type, as changed, meets the requirements of clause 2.3 of this Schedule.
 (3) For the purpose of enabling the examination to be carried out, the manufacturer must have available, in writing, details of any consequential changes to the documentation required under subclause 2.3(3) of this Schedule in relation to the type.

2.5  Records
 (1) The manufacturer of the type that has been examined under this Part must keep the following records:
 (a) the documentation required under subclause 2.3(3) of this Schedule in relation to the type;
 (b) details of any changes made to the type and to the documentation required under subclause 2.3(3) of this Schedule;
 (c) any notice, report, certificate or other document in relation to the type 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 of that type.
 (3) On request from the Secretary, the manufacturer must make the records available to the Secretary.

Part 3—Verification procedures

3.1  Overview
  The conformity assessment procedures set out in this Part provide for the manufacturer of a kind of medical device:
 (a) to arrange for examination and testing of the kind of device by the Secretary or an Australian conformity assessment body; 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.

3.2  References to kinds of medical devices
  A reference in this Part to a kind of medical device