Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:6:p4
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 6 (pt 4/19)
Character Range: 227726–230382

the person withdraws the application mentioned in paragraph (3)(a);
 (b) that application lapses under section 41FK of the Act;
 (c) that application is finally determined.
 (4A) Clauses 4.5 to 4.8 of Schedule 2, as added by Schedule 2 to the amending regulations, do not apply in relation to a transitional kind of medical device before the day applicable under subregulation (4B) if:
 (a) on or after 25 February 2021, and before 1 November 2024, the person makes an application under section 41EB of the Act for a conformity assessment certificate in respect of a kind (the new kind) of medical device; and
 (b) the person has not, before 1 November 2024, made an application under the Act to have the new kind of medical device included in the Register; and
 (c) the person has not withdrawn the conformity assessment certificate application before 1 November 2024; and
 (d) the conformity assessment certificate application has not lapsed under section 41EG of the Act before 1 November 2024; and
 (e) the person gives the Secretary a notice under regulation 11.46 in relation to the transitional kind of medical device; and
 (f) the unique product identifier of the new kind of medical device contained in the conformity assessment certificate application is the unique product identifier, or one of the unique product identifiers, stated in the notice.
 (4B) For the purposes of subregulation (4A), the applicable day is the later of 1 November 2024 and the day after the earliest of the following days:
 (a) the day the person withdraws the conformity assessment certificate application;
 (b) the day that application lapses under section 41EG of the Act;
 (c) in the case of a decision to not issue the conformity assessment certificate and where there is no longer any possibility of a change in the outcome of that decision—the first day on which there is no longer that possibility;
 (d) in the case of a decision to issue the conformity assessment certificate:
 (i) if, at the end of the period of 6 months beginning on the day of the issue of the certificate, the person has not made an application under the Act to have the new kind of medical device included in the Register—the last day of that 6‑month period; or
 (ii) if, before the end of the period of 6 months beginning on the day of the issue of the certificate, the person has made an application under the Act to have the new kind of medical device included in the Register—the day applicable under subregulation (4C).
 (4C) For the purposes of subparagraph (4B)(d)(ii), the applicable day is the day after the day on whichever of the following events occurs first:
 (a) the person