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 Classification	Description	Examples	Risk Level
Class I	Simple with history of safe use	Scalpels, compression bandages, dental kits	Low
Class II a	Â relatively low risk to the human body	Hearing aids, masks for providing anaesthesia,	Low - Moderate
Class II b	Relatively high risk to the human body	Condoms, blood bags, infusion pumps,	High - Moderate
Class III	Devices that may endanger the Patient's life	Cardiovascular stents, joint prostheses, heart valves	High

Premarket Approval Process

Class I (non-measuring, non-sterile)	Class I (sterile, measuring)	Class II a	Class II b	Class III
Pre-market approval of medical devices is not necessary in New Zealand (NZ). However, NZ requires theÂ 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

Validity	Does not expire
Postmarket Surveillance	Implement necessary corrective actions. Report adverse events and device recalls.

Obtain approval in

New Zealand

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