New Zealand medical device registration resources

Competent authority

Medsafe (New Zealand Medicines and Medical Devices Safety Authority) is the regulator that administers medical device regulation under the Medicines Act 1981 and the Medicines Regulations 1…

Therapeutic Products Act 2023 repealed

The Therapeutic Products Act 2023 was repealed by section 3 of the Therapeutic Products Act Repeal Act 2024, which came into force on 18 December 2024 (day after 17 December 2024 assent); t…

Ancillary legislation overlays

Depending on the device, other statutes also apply: Electricity Act 1992 (all electrically powered devices; Energy Safety), Radiation Protection Act 1965 (Office of Radiation Safety), Radio…

Official legal and guidance surface

primaryLegislation: Medicines Act 1981 · secondaryLegislation: Medicines Regulations 1984; Medicines (Database of Medical Devices) Regulations 2003 (SR 2003/325, in force 1 January 2004) ·…

IVD scope and notification exemption

IVDs are categorised as medical devices under the Medicines Act 1981, but are currently exempt from mandatory notification to the WAND database; they may be voluntarily notified, and suppli…

Medical device definition (s 3A)

A medical device is any device, instrument, apparatus, appliance or other article intended to be used in, on, or for human beings for a therapeutic purpose, that does not achieve its princi…

Classes I, IIa, IIb, III and AIMD (Medicines (Database of Medical Devices) Regulations 2003).

Class I, Class IIa, Class IIb, Class III, Class AIMD

Schedule 1 exempt devices

Exempt from WAND notification (Schedule 1): devices that are also medicines; custom devices made to a registered health professional's design specification for a particular patient; devices…

IVD exemption Gazette declaration

The Director General declared, under paragraph (i) of Schedule 1 and by notice in the New Zealand Gazette, that 'any diagnostic device that is commonly known as an in vitro diagnostic devic…

China NMPA approval: no recognition regime

statement: New Zealand has no pre market approval system for medical devices: there is no mandatory requirement for a device to be approved by any regulator before supply, and WAND notifica…

No foreign product approval needed

No foreign regulatory approval is required or assessed: there is no mandatory requirement for medical devices to be approved by any medical device regulator prior to being supplied in New Z…

Sponsor role definition

'Sponsor' means a person in New Zealand who exports or arranges export of the device from New Zealand, imports or arranges import of the device into New Zealand, or manufactures or arranges…

Sponsor New Zealand address requirement

The sponsor must be recorded in the database with the address of its registered office or principal place of business in New Zealand, plus a contact telephone number or email address for bo…

No establishment licence; importers are sponsors

New Zealand operates no establishment licence or importer authorisation scheme for medical devices: the import control is that a person in New Zealand who imports or arranges importation qu…

Sponsor declaration content

With each notification the sponsor (or an employee) must provide a declaration that: the product is a medical device and is correctly classified under the regulations; the sponsor will only…

WAND data elements

Information required per non exempt device (reg 5): the risk classification; names of manufacturer and sponsor with their registered office/principal place addresses and a contact phone or…

Official form or portal surface

portal: WAND (Web Assisted Notification of Devices) online database · accessSupport: devices@health.govt.nz · adverseEventForms: Medsafe adverse event report forms published separately for…

Manufacturer or NZ distributor name on device

Medicines Regulations 1984 reg 12(4): no person may sell a medical device that does not bear the name of the manufacturer, or the name of the manufacturer's distributor in New Zealand.

No IFU-specific legislation

There are no specific legislative or regulatory requirements for medical device IFUs under the Medicines Act 1981 or Medicines Regulations 1984; Medsafe recommends following international b…

No source-verified answer is published for this dimension yet.

Electricity Act 1992 compliance

Adapters / components

Radiation Safety Act 2016 source and use licences

Radiation

Radiocommunications Act 1989 supplier declaration against the Radio Standards Notice

Wireless / radio

WAND database notification (all device classes)

NZD 0

All devices (WAND notification) · Notification to the Web Assisted Notification of Devices (WAND) database

0 days

No expiry or renewal for WAND entries

WAND entries carry no expiry date: the Medicines (Database of Medical Devices) Regulations 2003 (regs 1 15) contain no renewal, re notification or retention event; the only continuing duty…

Change update within 10 working days

If recorded WAND information ceases to be accurate or complete — whether through a change of circumstances (for example a change in the name of the manufacturer or sponsor), a lapse in any…

No UDI scheme; WAND listing instead

The 2003 Database Regulations establish no UDI scheme; device traceability rests on the WAND entry — GMDNS product description for all notified devices plus a unique product identifier (tra…

Device clinical trials not approved by Medsafe

Medsafe does not regulate or approve clinical trials for medical devices in New Zealand, but requests that it be informed of them before commencement; trials require ethics committee approv…

Custom and practitioner-supplied device exemption

Custom devices — manufactured in response to a registered health professional's request specifying the design characteristics and intended for use only in relation to a particular patient (…

Personal-use import exemption

A medical device imported by a person solely for that person's own use is an exempt medical device (Schedule 1(g)) and need not be notified to WAND; all other Medicines Act requirements sti…

Sponsor compliance and recall procedures

The sponsor must put in place any procedures necessary to ensure compliance with the notification, information and update regulations (regs 5, 6 and 8). Medsafe additionally expects every s…

Adverse event reporting deadlines

For events involving death or serious deterioration in health, sponsors should submit an initial report as soon as possible and within 10 calendar days, and a final report within 120 calend…

Reportable events and reporters

Anyone can report an issue associated with a medical device to Medsafe at devices@health.govt.nz; patients, caregivers, healthcare professionals and suppliers are encouraged to report under…

Recall Code and Medsafe consultation

Recalls and other corrective actions should be conducted in consultation with Medsafe according to the New Zealand Medicines and Medical Devices Recall Code (latest edition in effect from 1…

No endorsement claims from WAND listing

No manufacturer or sponsor may publish any statement that directly or by implication indicates or suggests that inclusion of a device in the WAND database is an endorsement of its safety or…

Advertising controls (Part 4)

Advertising of devices with claimed therapeutic properties must comply with the Medicines Act and Regulations: Medicines Act 1981 Part 4 (ss 56 62) restricts false or misleading advertising…

No application decision to appeal

Because WAND is a notification only system with no application decision, deficiency responses and appeal rights for market entry do not arise; Medsafe states notification does not mean or i…