Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:6:p2
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 6 (pt 2/19)
Character Range: 222957–225606

(b) that application lapses under section 41FK of the Act; or
 (c) that application is finally determined.
 (5) If:
 (a) a person is required under regulation 11.41 to give a notice to the Secretary in relation to a transitional medical device; and
 (b) the person fails to give the notice in accordance with that regulation before the later of:
 (i) 25 May 2022; and
 (ii) the day occurring 2 months after the inclusion day for the entry of the transitional medical device;
then the amendments made by Parts 1 to 6 of Schedule 1 to the amending regulations, and the amendments made by Part 4 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, apply in relation to the transitional medical device on and after the later of those days.

11.41  Transitional medical devices—Secretary must be notified of unique product identifiers of devices supplied under pre‑commencement entries
 (1) For the purposes of subsection 41FN(5A) of the Act, a person must give to the Secretary a notice in accordance with subregulation (2) if:
 (a) a kind of medical device is included in the Register in relation to the person; and
 (b) the entry of that kind of medical device is a pre‑commencement entry; and
 (c) a medical device of that kind is a transitional medical device.
 (2) The notice must:
 (a) be in writing; and
 (b) state:
 (i) the unique device number assigned to that kind of device under section 41FL of the Act; and
 (ii) the unique product identifier given to each medical device (if any) of that kind that the person supplies in Australia; and
 (c) be given to the Secretary before the later of:
 (i) 25 May 2022; and
 (ii) the day occurring 2 months after the inclusion day for the entry of the transitional medical device.

11.42  Transitional medical devices—selecting applications for auditing
  Subregulation 5.3(1) does not apply to an application for inclusion of a kind of medical device in the Register as a Class III medical device if the application is for a transitional AIMD device.

11.43  Waiver of certain application fees
 (1) This regulation applies in relation to an application to include in the Register a transitional AIMD device as a Class III medical device.
 (2) The Secretary must waive the fee set out in paragraph (b) of column 2 in item 1.5 of the table in Part 1 of Schedule 5 in relation to the application.
 (3) This regulation ceases to have effect at the end of 24 November 2022.

Subdivision C—Programmed or programmable medical device or software that is a medical device

11.44  Definitions
  In this Subdivision:
inclusion day for an entry of a kind of medical