Therapeutic Goods (Medical Devices—Excluded Purposes) Specification 2020
4AExcluded purposes—Class 1 IVD medical devices
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4A Excluded purposes—Class 1 IVD medical devices
(1) This section applies in relation to medical devices that are: (a) IVD medical devices for self-testing; and (b) Class 1 IVD medical devices; and (c) not intended to be used exclusively for testing to monitor a disease or condition that has been diagnosed by a suitably qualified health professional; and (d) not intended exclusively for export; and (e) not intended to be used exclusively for testing as part of a government health screening program. (2) The purposes mentioned in Part 1A of Schedule 1 are specified for the purposes of paragraph 41FD(ia) and subsection 41FF(1A) of the Act.