Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:2:p25
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 2 (pt 25/40)
Character Range: 100434–103313

(a) if the Australian conformity assessment body applies in writing to the Secretary; or
 (b) on the Secretary's own initiative.
 (3) A variation under this regulation takes effect on the day specified for the purpose in the notice.
 (4) The day specified in the notice under subregulation (3) must be at least 20 working days after the notice is given to the body, unless the body:
 (a) applied for the variation; and
 (b) has agreed to an earlier day.
 (5) For the purposes of subregulation (4), the earlier day must not be earlier than the day the notice is given to the body.

4A.30  Notice of proposed variation
 (1) Before varying a conformity assessment body determination under this Division, the Secretary must:
 (a) notify the Australian conformity assessment body in writing that the Secretary proposes the variation and set out the reasons for it; and
 (b) give the body a reasonable opportunity to make submissions to the Secretary in relation to the proposed variation.
 (2) The Secretary must not make a decision relating to the proposed variation until the Secretary has had regard to any submissions the body makes under paragraph (1)(b).
 (3) This regulation does not apply if the body applied for the variation.

Division 4A.7—Australian conformity assessment body certificates

4A.31  Content of Australian conformity assessment body certificates
  For the purposes of subsection 41EWB(2) of the Act, the information is all of the following:
 (a) the name and address of the body issuing the certificate;
 (b) the body's ACN (within the meaning of the Corporations Act 2001);
 (c) the unique identification number assigned to the body under subsection 41EWA(4A) of the Act;
 (d) a unique identification number for the certificate;
 (e) the day on which the certificate is issued;
 (f) the name and address of the manufacturer of the medical devices;
 (g) the conformity assessment procedures applied to the medical devices by the manufacturer;
 (h) if the certificate covers a medical device to which paragraph 1.6(a), (b), (c) or (d) applies—the unique product identifier of the device;
 (i) if the certificate is varied—the day and details of the variation;
 (j) if one or more Australian conformity assessment body certificates have previously been issued in respect of the medical devices by the body—the information covered by paragraphs (a) to (i) in relation to each of those certificates.

Part 5—Including medical devices in the Register

Division 5.1—Including medical devices in the Register
Note: Regulation 5.1 is intentionally not used.

Subdivision A—Applications

5.2  Matters to be certified—period for obtaining information from manufacturer (Act s 41FD)
  For subparagraphs 41FD(e)(ii) and (g)(ii) of the Act, the period is 20 working days.

Subdivision C—Auditing of applications

5.3  Selecting applications for auditing (Act s 41FH)
 (1)