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.