Medicines (Database of Medical Devices) Regulations 2003

Schedule 1
Exempt medical devices

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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.