Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:5:p28
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 5 (pt 28/30)
Character Range: 206682–209413

unique product identifier given to the device by its manufacturer to identify the device and any variants.

11.29  Surgical mesh—application of amendments

Applications and entries other than pre‑commencement entries
 (1) The amendment made by Part 1 of Schedule 1 to the amending regulations applies on and after 1 December 2018 in relation to the following:
 (a) an application for a kind of medical device to be included in the Register, if the application is made on or after 1 December 2018;
 (b) an entry of a kind of medical device in the Register that is not a pre‑commencement entry.

Pre‑commencement entries
 (2) Subject to subregulations (3) and (4A), the amendment made by Part 1 of Schedule 1 to the amending regulations applies in relation to a pre‑commencement entry of a kind of medical device on and after:
 (a) if medical devices of that kind are urogynaecological mesh—1 December 2020; or
 (b) otherwise—1 December 2021.
 (3) The amendment does not apply in relation to the pre‑commencement entry before the day mentioned in subregulation (4) if:
 (a) the person applies under the Act:
 (i) on or after the inclusion day for the pre‑commencement entry; and
 (ii) on or after the commencement of Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021; and
 (iii) before 1 December 2021;
  to have a kind of medical device included in the Register; and
 (b) that kind of medical device is surgical mesh (other than urogynaecological mesh).
 (4) For the purposes of subregulation (3), the day is the day after the day on which:
 (a) the person withdraws the application mentioned in paragraph (3)(a); or
 (b) that application lapses under section 41FK of the Act; or
 (c) that application is finally determined.
 (4A) The amendment referred to in subregulation (2) does not apply in relation to the pre‑commencement entry before the day applicable under subregulation (4B) if:
 (a) the kind of medical device covered by that entry is surgical mesh (other than urogynaecological mesh); and
 (b) the person has not made an application of the kind covered by subregulation (3) (as in force before or after the commencement of this subregulation) before 1 December 2021; and
 (c) on or after 1 July 2020 and before 1 December 2021, the person made an application under section 41EB of the Act for a conformity assessment certificate in respect of a kind of medical device that is surgical mesh (other than urogynaecological mesh); and
 (d) the person has not withdrawn that application before 1 December 2021; and
 (e) that application has not lapsed under section 41EG of the Act before 1 December 2021; and
 (f) if the conformity assessment certificate was issued