Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:3:p30
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 3 (pt 30/43)
Character Range: 417084–419819

of a medical device to which technical documentation prepared under clause 6.4 of this Schedule applies must keep the following records:
 (a) the technical documentation prepared under clause 6.4 of this Schedule, including any revisions of the documentation prepared as a result of changes to the design or production of the kind of device;
 (b) details of any changes made to the design or production of the kind of medical device and to the documentation required under clause 6.4 of this Schedule;
 (c) the declaration of conformity under clause 6.6 of this Schedule.
 (2) The manufacturer must keep the records for at least 5 years after the manufacture of the last medical device to which the technical documentation prepared clause 6.4 of this Schedule applies.
 (3) On request from the Secretary, the manufacturer must make the records available to the Secretary.

Part 6A—Procedures applying to Class 1, 2 and 3 in‑house IVD medical devices

6A.1  Overview
  The conformity assessment procedures set out in this Part provide for the manufacturer of a Class 1 in‑house IVD medical device, Class 2 in‑house IVD medical device or Class 3 in‑house IVD medical device to do the following:
 (a) implement procedures relating to the application of a quality management system to the manufacture of the device;
 (b) provide information to the Secretary about the quality management system and the device;
 (c) establish and keep up‑to‑date a post‑market monitoring, reporting and corrective action system.

6A.2  Procedures

Notification of devices being manufactured
 (1) The manufacturer of a Class 1 in‑house IVD medical device, Class 2 in‑house IVD medical device or Class 3 in‑house IVD medical device must notify the Secretary, in accordance with subclauses (2) and (3), of all the Class 1, 2 or 3 in‑house IVD medical devices being manufactured.
 (2) A notification under subclause (1) must:
 (a) be in a form approved in writing by the Secretary; and
 (b) contain the information required by the form; and
 (c) cover each Class 1, 2 or 3 in‑house IVD medical device being manufactured at the time the notification is given.
 (3) A notification under subclause (1) must be given to the Secretary:
 (a) if the manufacturer manufactures one or more Class 1, 2 or 3 in‑house IVD medical devices before 1 July 2017—no later than 20 working days after 1 July 2017; and
 (b) if, in a financial year, the manufacturer starts to manufacture a Class 1, 2 or 3 in‑house IVD medical device not covered by the most recent of any previous notification given to the Secretary under subclause (1)—by the later of the following:
 (i) 1 July of the next financial year;
 (ii) 20 working days after manufacturing the device for the first time.