Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:5:p3
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 5 (pt 3/30)
Character Range: 143494–146258

of Schedule 1 to the medical devices, and the reason for the medical devices not complying with one or more of those clauses is that the medical devices are affected by the EU transition (within the meaning of subregulation (3)); or
 (iii) both subparagraphs (i) and (ii);
the amount of the fee is not worked out in accordance with Part 1 of Schedule 5. Instead, the amount of the fee is worked out in accordance with the following method statement:

      Method statement
           Step 1. Work out the number of separate entries in the Register in relation to the devices concerned.
           Step 2. The amount of the fee is the number at step 1 multiplied by $31.
 (3) For the purposes of this regulation, a medical device is affected by the EU transition if:
 (a) the medical device is of a kind included in the Register; and
 (b) the basis of certifying the matter referred to in paragraph 41FD(f) of the Act for devices of that kind was an overseas regulator conformity assessment document issued under one of the following (as in force from time to time):
 (i) Council Directive 90/385/EEC of the Council of the European Communities;
 (ii) Council Directive 93/42/EEC of the Council of the European Communities;
 (iii) Directive 98/79/EC of the European Parliament and the Council of the European Union;
 (iv) ISO 13485, Medical devices—Quality management systems—Requirements for regulatory purposes, published by the International Organization for Standardization; and
 (c) a new overseas regulator conformity assessment document has been issued, or is expected to be issued, in respect of devices of that kind under one of the following:
 (i) Regulation 2017/745 (as in force from time to time) of the European Parliament and the Council of the European Union;
 (ii) Regulation 2017/746 (as in force from time to time) of the European Parliament and the Council of the European Union;
 (iii) the Medical Device Single Audit Program (within the meaning of the Therapeutic Goods (Overseas Regulators) Determination 2018).

Division 9.2—Conformity assessment body determination assessment fees

9.1A  Purposes of this Division
  This Division is made for the purposes of paragraph 41EWA(3)(g) of the Act.

9.1B  Conformity assessment body determination assessment fees
 (1) A fee is payable in relation to the assessment of an application for a conformity assessment body determination mentioned in column 2 of item 1.4D, 1.4E or 1.4F in Part 1 of Schedule 5.
 (2) Subject to regulation 9.1C, the amount of the fee is the amount mentioned in column 4 of that item.
 (3) The fee is payable by the applicant.
 (4) Subject to regulation 9.1D, the fee is due and payable in full on the day specified under subregulation (5) of this regulation.
 (5) For the