Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:2:p10
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 2 (pt 10/40)
Character Range: 60642–63560

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 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 demonstrating that the safety or performance of the new device when used for that intended purpose provides a significant improvement compared to the existing devices;
 (c) at least one of the following applies to the new device:
 (i) the new device is a breakthrough technology and there is evidence that it offers a major clinical advantage over existing technology;
 (ii) there is evidence that the new device offers a major clinical advantage over existing alternatives included in the Register;
 (iii) the new device is an IVD medical device and its early availability in Australia will result in a major public health benefit.

Information to be specified in determination
 (3) The determination must specify:
 (a) the person who, as a result of section 41ECA of the Act, is the priority applicant; and
 (b) the medical device to which the determination relates; and
 (c) the intended purpose of the medical device.

Notification of decision
 (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.
 (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.

4.3D  Period during which conformity assessment (priority applicant) determination is in force
 (1) A conformity assessment (priority applicant) determination in relation to a medical device:
 (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 4.3C(4); and
 (b) subject to subregulation (2) and regulation 4.3E, remains in force for 6 months.
 (2) If the priority applicant specified in the determination makes an effective application under section 41EB of the Act for a conformity assessment certificate that covers the medical device before the end of the 6 month period beginning when the determination comes into