New Zealand Legislation: Regulations
Regulations are laws made under Acts
Schedule 1 |
The following are exempt medical devices:
(a) any medical device (other than a medical device to which clause 13(2) of Schedule 2 applies) that is also a medicine (within the meaning of section 3(1) of the Act):
(b) any medical device that is—
(i) manufactured in response to a request by a registered health professional (within the meaning of section 2(1) of the Act) that specifies the design characteristics of the device; and
(ii) intended to be used only in relation to a particular patient:
(c) a medical device supplied to a practitioner (within the meaning of section 2(1) of the Act) for use in relation to a particular patient of the practitioner:
(d) any medical device that—
(i) has been imported into New Zealand; and
(ii) is being held by the New Zealand Customs Service pending export from New Zealand to another country:
(e) any diagnostic device that is—
(i) commonly known as an in vitro diagnostic device; and
(ii) intended for use only within a particular laboratory:
(f) any diagnostic device made in a laboratory that is intended for use in another laboratory (whether or not as a consequence of the purchase of the device by the owner of the other laboratory or otherwise):
(g) any medical device imported by a person solely for that person's own use:
(h) any medical device imported for use in a clinical trial:
(i) any medical device that is included in any class of medical device declared to be an exempt class of medical device by notice issued by the Director-General in the Gazette.
