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

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.

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	It is a mandatory requirement for importers to notify their medical devices to the database. There is no approval system for medical devices under the Medicines Act 1981. There is no mandatory requirement for medical devices to be approved by any medical device regulator prior to being supplied in New Zealand.
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.

Need More Information