New Zealand Medical Device Regulations
Regulatory Agency
MEDSAFE (New Zealand Medicines and Medical Devices Safety Authority) regulates medical devices in New Zealand.
Medical Device Definition
Medical Device:
а) means any device, instrument, apparatus, appliance, or other article that –
i. is intended to be used in, on, or for human beings for a therapeutic purpose; and
ii. does not achieve its principal intended action in or on the human body by pharmacological, immunological, or metabolic means (but may be assisted in its function by such means); and
b) includes a material that –
i. is intended to be used in or on human beings for a therapeutic purpose; and
ii. does not achieve its principal intended action in or on the human body by pharmacological, immunological, or metabolic means (but may be assisted in its function by such means); and
c) also includes –
i. anything that is intended to be used with a device, instrument, apparatus, appliance, article, or material referred to in paragraph (a) or (b) to enable the device, instrument, apparatus, appliance, article, or material to be used as its manufacturer intends; and
ii. any device, instrument, apparatus, appliance, article, or material of a kind or belonging to a class that is declared by regulations to be a medical device for the purposes of the Medicines Act; but
d) does not include a device, instrument, apparatus, appliance, article, or material of a kind or belonging to a class that is declared by regulations not to be a medical device for the purposes of the Medicines Act.
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:
(a) means a medical device that is intended by the manufacturer-
(i) to depend for its operation on a source of electrical energy or other sources of energy (other than a source of energy generated directly by a human being or gravity); and
(ii) to act by converting that energy; but
(b) 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.
Medical Device Classification System
| International Classification | Risk Level | Examples |
|---|---|---|
| Class I basic | Low Risk | Reusable surgical instruments |
| Class I measuring | Low Risk | Volumetric urine bag |
| Class I sterile | Low Risk | Sterile dressings, non-medicated |
| Class IIa | Low–moderate risk | Hypodermic needles, suction equipment |
| Class IIb | Medium-high risk | Ventilators, orthopedic implants |
| Class III & Active implantable medical device(AIMD) | High risk | Drug-eluting cardiac stents, Implantable pacemaker |
Regulatory Approval Process
Classification | Approval procedure |
|---|---|
Class I
Class IIa
Class IIb
Class III |
|
Additional Information
Approval timeline | within 30 days of commercialization. |
License validity period | N/A |
Fees | All information is submitted free of charge to the WAND database. |
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