Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(1) For the purposes of paragraph 41FH(1)(a) of the Act, and subject to this regulation, an application for any of the following kinds of medical devices to be included in the Register is prescribed:
(a) a Class III medical device;
(b) any of the following IVD medical devices:
(i) a Class 3 IVD medical device;
(ii) a Class 4 IVD medical device;
(iii) a Class 4 in - house IVD medical device;
(iv) an IVD medical device that is intended for self - testing;
(v) an IVD medical device that is intended for point of care testing.
(2) Subregulation (1) does not apply to an application for a kind of medical device to be included in the Register if a conformity assessment certificate, or an Australian conformity assessment body certificate, has been issued, and has not been suspended or revoked, in respect of the kind of medical device.
(2AA) Subregulation (1) does not apply to an application for a kind of medical device to be included in the Register if:
(a) an overseas regulator conformity assessment document has been issued, in respect of the kind of medical device, by a notified body (within the meaning of the Therapeutic Goods (Overseas Regulators) Determination 2018 ) in accordance with:
(i) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, as in force from time to time; or
(ii) Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices, as in force from time to time; and
(b) the overseas regulator conformity assessment document has not been suspended or revoked.
(2AB) Subregulation (1) does not apply to an application for a kind of medical device to be included in the Register if:
(a) the kind of medical device:
(i) is the subject of a medical device licence issued by Health Canada under the Medical Devices Regulations (Canada); or
(ii) is the subject of an order approving an application for premarket approval from the US Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act (United States of America); or
(iii) is the subject of a pre - market certification or approval issued by the Japanese Ministry of Health, Labour and Welfare, or the Japanese Pharmaceuticals and Medical Devices Agency, under The Law on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Japan); or
(iv) is the subject of an entry in the Register of Health Products kept and maintained by the Health Sciences Authority of Singapore under the Health Products Act 2007 (Singapore); or
(v) has been certified in accordance with the Australia - UK Mutual Recognition Agreement, the EC Mutual Recognition Agreement or the EFTA Mutual Recognition Agreement; and
(b) the licence, order, approval, certification or entry has not:
(i) been suspended, revoked or restricted (however described); or
(ii) otherwise ceased to be in effect.
(2A) Subregulation (1) does not apply to an application for a medical device that is covered by clause 5.8 of Schedule 2 or clause 1.8 of Schedule 2A.