Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:2:p9
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 2 (pt 9/40)
Character Range: 58057–60936

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.

4.3  Time for making decision on applications (Act s 41ED, s 63(2)(dc))
 (1) This regulation applies to an application for the issue of a conformity assessment certificate in respect of a kind of medical device if, in considering the application, the Secretary is required to examine the design of the device.
 (2) The Secretary must make a decision on the application within 255 working days after the application is received at an office of the Department specified by the Secretary.
 (3) For subregulation (2), a working day that occurs in any of the following periods is to be disregarded:
 (a) if the Secretary sends a query, or a request for information, to the applicant or sponsor—the period beginning on the day when the query or request is sent and ending at the end of the day when the Secretary receives from the applicant or sponsor a response that enables the Secretary to proceed with the assessment;
 (b) if an appeal is lodged in relation to the application—the period beginning on the day when the appeal is lodged and ending at the end of the day when the appeal is finally determined;
 (c) any other period in relation to which the applicant or sponsor agrees in writing for the purposes of this subregulation.

Division 4.1A—Conformity assessment (priority applicant) determinations

4.3A  Application of Division
  For the purposes of subsection 41ECA(1) of the Act, this Subdivision makes provision for and in relation to the making of conformity assessment (priority applicant) determinations.

4.3B  Application for conformity assessment (priority applicant) determination
 (1) A person may apply to the Secretary for a conformity assessment (priority applicant) determination in relation to a medical device.
 (2) An application under subregulation (1) must:
 (a) be in writing; and
 (b) be in a form approved, in writing, by the Secretary; and
 (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.
 (3) An application under subregulation (1) is taken not to have been made unless:
 (a) the application meets the requirements in subregulation (2); and
 (b) the fee prescribed in item 1.1A of Part 1 of Schedule 5 for making the application has been paid.

4.3C  Making of conformity assessment (priority applicant) determination
 (1) On receiving an application under subregulation 4.3B(1) for a conformity assessment (priority applicant) determination in relation to a medical device, the Secretary must:
 (a) consider the application; and
 (b) decide either:
 (i) to make the