Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:2:p27
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 2 (pt 27/40)
Character Range: 105517–108464

and Welfare, or the Japanese Pharmaceuticals and Medical Devices Agency, under The Law on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Japan); or
 (iv) is the subject of an entry in the Register of Health Products kept and maintained by the Health Sciences Authority of Singapore under the Health Products Act 2007 (Singapore); or
 (v) has been certified in accordance with the Australia‑UK Mutual Recognition Agreement, the EC Mutual Recognition Agreement or the EFTA Mutual Recognition Agreement; and
 (b) the licence, order, approval, certification or entry has not:
 (i) been suspended, revoked or restricted (however described); or
 (ii) otherwise ceased to be in effect.
 (2A) Subregulation (1) does not apply to an application for a medical device that is covered by clause 5.8 of Schedule 2 or clause 1.8 of Schedule 2A.

Subdivision D—Miscellaneous—medical devices (priority applicant) determinations

5.4  Application of Subdivision
  For the purposes of subsection 41FKA(1) of the Act, this Subdivision makes provision for and in relation to the making of medical devices (priority applicant) determinations.

5.4A  Application for medical devices (priority applicant) determination
 (1) A person may apply to the Secretary for a medical devices (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 1.5A of Part 1 of Schedule 5 for making the application has been paid.

5.4B  Making of medical devices (priority applicant) determination
 (1) On receiving an application under subregulation 5.4A(1) for a medical devices (priority applicant) determination in relation to a medical device, the Secretary must:
 (a) consider the application; and
 (b) decide either:
 (i) to make the determination; or
 (ii) to refuse to make the determination.

Criteria
 (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medical device (the new device):
 (a) the intended purpose of the new device is the monitoring, treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;
 (b) either:
 (i) no medical devices with that intended purpose are of a kind included in the Register; or
 (ii) if one or more medical devices with that intended purpose are of a kind included in the Register (the existing devices)—there is substantial evidence