Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:2:p8
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 2 (pt 8/40)
Character Range: 55509–58353

the manufacturer of the system or procedure pack must ensure that the method to be used for sterilisation or resterilisation is appropriate or is in accordance with the approved indications of the medicine.

3.11  Medical devices to which the clinical evaluation procedures must be applied
 (1) Subject to subregulation (2), in addition to the conformity assessment procedures that are applied to a medical device in accordance with another regulation in this Division, the clinical evaluation procedures must also be applied to the device, for the purpose of demonstrating that the device complies with the applicable provisions of the essential principles, in particular:
 (a) clause 1 of Schedule 1 (identification of the benefits and risks associated with the use of the device); and
 (b) clause 3 of Schedule 1 (use of the device for its intended purpose); and
 (c) clause 6 of Schedule 1 (acceptability of any side effects associated with the use of the device).
 (2) This regulation does not apply to any of the following:
 (a) an exempt device (other than an exempt device of a kind described in item 1.3 of Schedule 4);
 (b) a medical device that is the subject of an approval under section 41HB of the Act;
 (c) a medical device that is the subject of an authority under section 41HC of the Act.
 (3) Despite subregulation (2), this regulation applies to a custom‑made medical device.

3.12  Records to be provided in English
  All records (including correspondence) provided by the manufacturer of a medical device in relation to the application of the conformity assessment procedures to the device must be in English.

3.13  Assessment or verification at intermediate stage of manufacture
 (1) At the request of a person, and on payment of the prescribed fee, the Secretary may arrange for assessment or verification procedures to be carried out in relation to the application of the conformity assessment procedures to an article that is intended to be used in the manufacture of a medical device.
 (2) A request may be made:
 (a) at any stage of the manufacturing process; and
 (b) whether or not an application has been made in relation to the article:
 (i) for a conformity assessment certificate in respect of a medical device; or
 (ii) for inclusion of a kind of medical device in the Register.

Part 4—Conformity assessment certificates

Division 4.1—Issuing conformity assessment certificates

4.2  Considering applications for conformity assessment certificates (Act s 41EC)
  For subsection 41EC(2) of the Act, the following other requirements of the conformity assessment procedures are specified:
 (a) the applicable requirements in relation to the establishment and maintenance of a post‑market monitoring, reporting and corrective action system;
 (b) the applicable requirements in relation to the keeping of records.