New Zealand Medical Device Regulations

Agency
All medical devices are regulated by the Medicines and Medical Device Safety Authority (MedSafe)
Medical Device Definition
A medical device means any device instrument, apparatus, appliance or other article-- (i) is intended to be used in, or, 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 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 this act; but (d) does not include a device, instrument, apparatus, appliance, article, or material of a kind belonging to a class that is declared by regulations not be a medical device for the purposes of this Act. Medicines Act 1981, Art. 3A
Classification of Medical Device
International ClassificationDescriptionExamplesRisk Level
Class ISimple with history of safe useScalpels, compression bandages, dental kitsLow
Class II a relatively low risk to the human bodyHearing aids, masks for providing anaesthesia,Low - Moderate
Class II bRelatively high risk to the human bodyCondoms, blood bags, infusion pumps,High - Moderate
Class IIIDevices that may endanger thePatient's lifeCardiovascular stents, joint prostheses, heart valvesHigh
Premarket Approval Process
Class I (non-measuring, non-sterile)Class I (sterile, measuring)Class II aClass II bClass III
Pre-market approval of medical devices is not necessary in New Zealand (NZ). However, NZ requires the manufacturer to comply with established standards, enforced by post-market surveillance.
Appoint a sponsor to list device in Web Assisted Notification of Devices (WAND). (System places vigilance responsibility on sponsor.)
Device must be listen on WAND within 30 days of commercialization
MedSafe may request information that proves your device's safety and effectiveness. Therefore, companies should ensure they have documentation such as a EU Notified Body or US FDA.
Additional Information
ValidityDoes not expire
Postmarket Surveillance Implement necessary corrective actions. Report adverse events and device recalls.
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