Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:3:p8
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 3 (pt 8/43)
Character Range: 360878–363705

of the person signing the declaration; and
 (j) state the date when the declaration is signed.

1.9  Records
 (1) The manufacturer of a kind of medical device to which a quality management system that has been assessed under clause 1.3 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 1.4(5) of this Schedule;
 (b) details of any changes made to the system and to the information and documentation required under subclause 1.3(2) of this Schedule;
 (c) if the device is a Class 4 IVD medical device, Class 4 in‑house IVD medical device or Class III medical device, the information and documentation required under subclause 1.6(3) of this Schedule;
 (d) details of any changes made to the kind of medical device and to the documentation in relation to the design of the device mentioned in paragraph 1.4(5)(c) of this Schedule;
 (e) the declaration of conformity under clause 1.8 of this Schedule;
 (f) details of the systematic review carried out, post‑production, in relation to medical devices of that kind;
 (g) 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 2—Type examination procedures

2.1  Overview
  The conformity assessment procedures set out in this Part provide for the manufacturer to arrange for examination by the Secretary or an Australian conformity assessment body of a representative sample of a kind of medical device (the type).
Note: See Division 3.2 in relation to the kinds of medical devices to which these conformity assessment procedures may be applied.

2.2  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.

2.3  Examination of type
 (1) The manufacturer of a medical device must arrange for examination of the type by the Secretary or an Australian conformity assessment body.
 (2) For the purpose of enabling the examination to be carried out, the manufacturer must have available, in writing, the following information:
 (a) the name and business address of the manufacturer;
 (b) the documentation mentioned in subclause (3) in relation to the type.
 (3) For paragraph (2)(b), the documentation must include adequate information about the design, production process and intended performance of the type, and must include, in particular, the following:
 (a) a general description of the