Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(1) This regulation applies in relation to the following kinds of medical devices:
(b) a Class III medical device;
(c) a Class IIb medical device that is an implantable medical device;
(d) a Class 4 IVD medical device.
(2) For the purposes of subsection 41FN(5A) of the Act, the person in relation to whom a medical device of that kind is included in the Register must, before 1 October after each reporting period for that kind of device, give the Secretary a report about that kind of device for the reporting period.
(3) The report must include the following:
(a) if no device of that kind was supplied in Australia or a foreign country during the reporting period--a statement to that effect;
(b) if the person became aware during the reporting period of information of a kind referred to in regulation 5.8 that relates to that kind of device--that information;
(c) if the person did not become aware during the reporting period of information of a kind referred to in regulation 5.8 that relates to that kind of device--a statement to that effect.
(4) For the purposes of this regulation, each of the following is a reporting period for a kind of medical device:
(a) the period:
(i) beginning on the day when that kind of device is included in the Register; and
(ii) ending at the end of the next 30 June;
(b) each of the next 2 financial years.
(5) If:
(a) on a day on or after 25 November 2021 medical devices of a kind (the current kind of medical device ) referred to in a particular paragraph of subregulation (1) are included in the Register because of the amendments made by the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019 ; and
(b) immediately before that day, those devices were of a kind (the previous kind of medical device ) referred to in a different paragraph of subregulation (1) and were included in the Register;
then subparagraph (4)(a)(i) applies in relation to the current kind of medical device as if the day when the current kind of medical device is included in the Register were the day when the previous kind of medical device was included in the Register.