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New Zealand Medical Device Regulations

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
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.
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