Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:5:p7
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 5 (pt 7/26)
Character Range: 661665–664908

assessment procedures to an article                                                                                                                                                                                    Subregulation 3.13(1) of these Regulations                                                             The fee applicable under item 1.9, 1.10 or 1.12 to the kind of work to be undertaken
1.17    Notification by a manufacturer, under subclause 6A.2(1) of Part 6A of Schedule 3, of Class 1, 2 or 3 in‑house IVD medical devices being manufactured                                                                                                                                                                                               Subsection 63(1) and paragraph 63(2)(h) of the Act                                                     1,209

Part 2—Additional fees

2.1  Supplementary assessment
  In addition to the assessment fee mentioned in item 1.2, 1.3, 1.9, 1.9A, 1.10 or 1.10A of this Schedule, the following fees apply:
 (a) for each assessment that is required to be conducted—an amount that reimburses the costs and reasonable expenses of travel by each assessor involved, including travel both in and outside Australia;
 (b) for an assessment that is required to be conducted outside Australia—an amount calculated at the rate of $496 for each hour of preparation by each assessor involved.

2.2  Costs of testing
 (1) In addition to the assessment fee mentioned in paragraph 1.3(b), 1.3A(e), 1.9(c) or (d), 1.9A(e) or paragraph 1.10(c) of this Schedule, a fee for the costs of testing the relevant kind of medical device, or quality management system, applies.
 (2) The fee is the amount that reimburses the Department for:
 (a) the costs incurred in purchasing, establishing and setting‑up the equipment to be used to conduct the tests; and
 (b) the direct costs of conducting the tests (including the cost of any consumables used in conducting the tests).

Dictionary
(regulation 1.3)

Note: A number of expressions used in these Regulations are defined in the Act.
Act means the Therapeutic Goods Act 1989.
active implantable medical device means an active medical device, other than an implantable medical device, that is intended by the manufacturer:
 (a) either:
 (i) to be, by surgical or medical intervention, introduced wholly, or partially, into the body of a human being; or
 (ii) to be, by medical intervention, introduced into a natural orifice in the body of a human being; and
 (b) to remain in place after the procedure.
active medical device:
 (a) means a medical device that is intended by the manufacturer:
 (i) to depend for its operation on a source of electrical energy or other source of energy (other than a source of energy generated directly by a human being or gravity); and
 (ii) to act by converting this energy; but
 (b) does not include a medical device that is intended by the manufacturer to transmit energy, a substance, or any other element, between an active medical device and a human being without any significant change in the energy, substance or other element being transmitted.
Software that is a medical device is an active medical device.
active medical device for