In these regulations, unless the context otherwise requires,—
accessory means an article that is intended by the manufacturer to be used together with a medical device to enable the device to be used as the manufacturer of the device intended
Act means the Medicines Act 1981
active implantable medical device or AIMD means an active medical device that is intended by the manufacturer—
either—
to be introduced wholly, or partially, into the human body by surgical or medical intervention; or
to be introduced into a natural orifice in the human body by medical intervention; and
to remain in place after the procedure
active medical device—
means a medical device that is intended by the manufacturer—
to depend for its operation on a source of electrical energy or other source of energy (other than a source of energy generated directly by a human being or gravity); and
to act by converting that energy; but
does not include a medical device that is intended by the manufacturer to transmit energy, a substance, or any other element, between a medical device to which paragraph (a) applies and a human being without any significant change in the energy, substance, or other element being transmitted
active medical device for diagnosis means an active medical device that is intended by the manufacturer to be used on a person, either alone or in combination with another medical device, to supply information for the purpose of detecting, diagnosing, monitoring, or treating physiological conditions, states of health, illnesses, or congenital deformities
active medical device for therapy means an active medical device that is intended by the manufacturer to be used on a person, either alone or in combination with another medical device, to support, modify, replace, or restore biological functions or structures for the purpose of treating or alleviating an illness, injury, or handicap
body orifice—
means a natural opening, or a permanent artificial opening, in a person’s body; and
includes the external surface of a person’s eyeball
Class I medical device means a medical device required by regulation 13 and Schedule 2 to be classified as a Class I medical device
Class IIa medical device means a medical device required by regulation 13 and Schedule 2 to be classified as a Class IIa medical device
Class IIb medical device means a medical device required by regulation 13 and Schedule 2 to be classified as a Class IIb medical device
Class III medical device means a medical device required by regulation 13 and Schedule 2 to be classified as a Class III medical device
Class AIMD (Active Implantable Medical Device) means a medical device required by regulation 13 and Schedule 2 to be classified as a Class AIMD medical device
database means the database of medical devices established and maintained under regulation 4
Director-General has the same meaning as it has in section 2(1) of the Act
exempt medical device means a medical device of the kind described in Schedule 1
implantable medical device means a medical device (other than an active implantable medical device) that is intended by the manufacturer—
to be wholly introduced into the human body by surgical intervention, and to remain in place after the procedure; or
to be partially introduced into the human body by surgical intervention, and to remain in place for at least 30 days after the procedure; or
to replace an epithelial surface or the surface of a person’s eye by surgical intervention, and to remain in place after the procedure
intended purpose, in relation to a medical device, means the purpose for which the manufacturer of the device intends it to be used, as stated in—
the information provided with the device; or
the instructions for use of the device; or
any advertising material relating to the device
invasive medical device means a medical device that is intended by the manufacturer to be used, in whole or in part, to penetrate the human body through a body orifice or through the surface of the body
medical device has the same meaning as it has in section 3A of the Act
Ministry of Health means the department of the public service referred to by that name
reusable surgical instrument means a medical device that is intended by the manufacturer—
to be used surgically, without being connected to an active medical device, for cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping, or any other similar procedure; and
to be reused after the appropriate procedures specified by the manufacturer in the instructions for use have been carried out
sponsor, in relation to a medical device,—
means—
a person in New Zealand who exports, or arranges the exportation of, the device from New Zealand:
a person in New Zealand who imports, or arranges the importation of, the device into New Zealand:
a person in New Zealand who manufactures the device in New Zealand, or arranges for another person to manufacture the device in New Zealand, for supply (whether in New Zealand or elsewhere); but
does not include a person who—
exports, imports, or manufactures a device; or
arranges for the exportation, importation, or manufacture of a device,—
on behalf of another person who, at the time of the exportation, importation, manufacture, or making of the arrangements, is a resident of, or is carrying on business in, New Zealand
surgically invasive medical device means—
an invasive medical device that is intended by the manufacturer to be used with the aid, or in the context, of a surgical operation:
a medical device that is intended by the manufacturer to be used to penetrate the human body in any way other than through a body orifice.
Regulation 3 medical device: amended, on 1 July 2014, by section 50 of the Medicines Amendment Act 2013 (2013 No 141).
Regulation 3 Ministry of Health: amended, on 7 August 2020, by section 135 of the Public Service Act 2020 (2020 No 40).