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	-If you do not have a physical presence in New Zealand, appoint a local Sponsor who has a registered business or principal place of business in Zealand. -No technical dossier is submitted for WAND listing. However, the device risk classification, GMDN code, intended purpose of the device, and supporting documentation for safety and effectiveness must be established. -Sponsor lodges a new Manufacturer Notification. Processing takes up to 5 business days. -Sponsor enters the medical device information (including classification and GMDN code) into the WAND database. If available, the Australian Register of Therapeutic Goods (ARTG) registration number may be provided (optional). There are no government fees associated with WAND notifications, and there is no review/approval process. -Begin marketing the device in New Zealand. Maintain the correctness and completeness of the device information in WAND.
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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