Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:2:p28
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 2 (pt 28/40)
Character Range: 108223–111077

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 41FKA 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.

5.4C  Period during which medical devices (priority applicant) determination is in force
 (1) A medical devices (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 5.4B(4); and
 (b) subject to subregulation (2) and regulation 5.4D, remains in force for 6 months.
 (2) If the priority applicant specified in the determination makes an application under section 41FC of the Act for that kind of medical device to be included in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:
 (a) the priority applicant withdraws the application; or
 (b) the application lapses in accordance with section 41FK of the Act; or
 (c) the application is finally determined.
Note: See subsection 41FDB(3) of the Act for when an application passes preliminary assessment.

5.4D  Revocation of medical devices (priority applicant) determination
 (1) The Secretary may revoke a medical devices (priority applicant) determination in relation to a medical device if:
 (a) either:
 (i) the priority applicant specified in the determination has not made an application under section 41FC of the Act for that kind of medical device to be included in the Register; or
 (ii) the