Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:2:p3
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 2 (pt 3/40)
Character Range: 42807–45665

that power or perform that function.
 (2) If, under the conformity assessment procedures, the manufacturer of the kind of medical device is required to give information of a kind mentioned in paragraph 41MP(2)(a) or (b) of the Act to the Secretary, the information must be given to the Secretary in addition to any such information that is given to the body or authority mentioned in subregulation (1).

3.6  Class III medical devices (other than medical devices used for a special purpose)
 (1) Subject to subregulation (2), the conformity assessment procedures that must be applied to a Class III medical device (other than a medical device used for a special purpose) are, as the manufacturer prefers:
 (a) the full quality assurance procedures; or
 (b) the type examination procedures and:
 (i) the verification procedures; or
 (ii) the production quality assurance procedures.
 (2) If the device is intended by the manufacturer to be supplied in a sterile state, the conformity assessment procedures that must be applied to the device are, as the manufacturer prefers:
 (a) the full quality assurance procedures; or
 (b) the type examination procedures and the production quality assurance procedures.

3.6A  Class 4 IVD medical devices (other than medical devices to be used for a special purpose)
  The conformity assessment procedures that must be applied to a Class 4 IVD medical device (other than a medical device to be used for a special purpose) are, as the manufacturer prefers:
 (a) the full quality assurance procedures; or
 (b) the type examination procedures and the production quality assurance procedures.

3.6B  Class 4 in‑house IVD medical devices (other than medical devices to be used for a special purpose)
  The conformity assessment procedures that must be applied to a Class 4 in‑house IVD medical device (other than a medical device to be used for a special purpose) are, as the manufacturer prefers:
 (a) the full quality assurance procedures; or
 (b) the conformity assessment procedures set out in Part 6B of Schedule 3.

3.7  Class IIb medical devices (other than medical devices used for a special purpose)
 (1) Subject to subregulation (2), the minimum conformity assessment procedures that must be applied to a Class IIb medical device (other than a medical device used for a special purpose) are, as the manufacturer prefers:
 (a) the full quality assurance procedures (other than clause 1.6); or
 (b) the type examination procedures and:
 (i) the verification procedures; or
 (ii) the production quality assurance procedures; or
 (iii) the product quality assurance procedures.
 (2) If the device is intended by the manufacturer to be supplied in a sterile state, the minimum conformity assessment procedures that must be applied to the device are, as the manufacturer prefers:
 (a) the full quality assurance procedures