Medsafe · East Asia & Pacific

New Zealand medical device regulatory resources

Every New Zealand dataset, comparison, and AI workpaper we maintain — one entry point for the whole market.

6 free resources24/25 topics with records15 regulations trackedAug 2026 fees reviewed

Run the classification agent

Everything we track for New Zealand

Medical device regulations

Browse official Medsafe regulations and guidance documents.

Additional certification and licence checker

Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other New Zealand requirements.

Medical device regulation news

Follow recent Medsafe, Ministry of Health policy, guidance, safety, and compliance updates.

Registration timeline

Compare official and realistic Medsafe approval times by device class and pathway.

AI medical device classifier

Describe your device and get a preliminary Medsafe risk class with official rule references.

Government registration fees

Check the current Medsafe position on device and IVD fees.

Changes after registration

Explore questions and sources →

Common questions about changing a registered medical device in New Zealand. Each question separates published rules from details still awaiting verification.

Does changing a device brand name or logo require an update? →Specific rules awaiting verification
How do I update a manufacturer's name without changing the legal entity? →Source-linked rules available
What changes when the manufacturer's office address changes? →Specific rules awaiting verification
Does a catalogue or reference code change affect registration or UDI? →Specific rules awaiting verification
Can a registration transfer to a different legal entity? →Specific rules awaiting verification
Can several changes be filed together? →Specific rules awaiting verification

Structured regulatory requirements

Explore all 41 source-linked facts →

24 of 25 research dimensions currently covered · 19 official sources · latest verification 2026-09-16

Market entry

D01

Authority & regime

Verified

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Therapeutic Products Act 2023 repealed: The Therapeutic Products Act 2023 was repealed by section 3 of the Therapeutic Products Act Repeal Act 2024, which came into force on 18 December 2024 (day after 17 December 2024 assent); t…

2 source-linked facts

Checked 2026-08-26

Open details →

D02

Legal basis & guidance

Verified

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) ·…

2 source-linked facts

Checked 2026-08-26

Open details →

D03

Device definition & scope

Verified

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…

3 source-linked facts

Checked 2026-08-26

Open details →

D04

Classification rules

Verified

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

1 maintained scheme · 4 related facts

Checked 2026-08-26

Open details →

D05

Registration pathways

Verified

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…

5 source-linked facts

Checked 2026-08-26

Open details →

D06

Reliance & recognition

Verified

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…

2 source-linked facts

Checked 2026-09-15

Open details →

D07

Economic-operator roles

Verified

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…

2 source-linked facts

Checked 2026-08-26

Open details →

D08

Establishment, import & distribution

Verified

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…

1 source-linked fact

Checked 2026-08-26

Open details →

D09

Dossier requirements

Verified

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…

2 source-linked facts

Checked 2026-08-26

Open details →

D10

Official forms & portals

Verified

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…

1 source-linked fact

Checked 2026-08-26

Open details →

Submission & evidence

D11

Label, IFU & language

Verified

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…

2 source-linked facts

Checked 2026-08-26

Open details →

D12

QMS, audit & inspection

Verified

Enforcement officers' entry, inspection and manufacturing-process examination powers expressly cover medical devices: statement: Medical devices are within the reach of New Zealand's statutory inspection machinery. Part 5 of the Medicines Act 1981 (Enforcement) gives an officer, at any reasonable time, pow…

1 source-linked fact

Checked 2026-09-16

Open details →

D13

Standards, testing & ancillary approvals

Unresolved

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

5 maintained overlays

Open details →

D14

Fees

Verified

WAND database notification (all device classes): NZD 0

1 maintained fee line · 1 related fact

Checked 2026-08-26

Open details →

D15

Review clocks

Verified

All devices (WAND notification) · Notification to the Web Assisted Notification of Devices (WAND) database: 0 days

1 maintained pathway

Checked 2026-08-30

Open details →

D16

Approval validity & renewal

Verified

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…

1 source-linked fact

Checked 2026-08-26

Open details →

Lifecycle & post-market

D17

Change control

Verified

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…

1 source-linked fact

Checked 2026-08-26

Open details →

D18

UDI, listing & traceability

Verified

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…

1 source-linked fact

Checked 2026-08-26

Open details →

D19

Clinical investigation & performance

Verified

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…

1 source-linked fact

Checked 2026-08-26

Open details →

D20

Special access & derogation

Verified

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…

2 source-linked facts

Checked 2026-08-26

Open details →

D21

Manufacturer PMS

Verified

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…

1 source-linked fact

Checked 2026-08-26

Open details →

D22

Vigilance & incident reporting

Verified

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…

2 source-linked facts

Checked 2026-08-26

Open details →

D23

Recall, FSCA & market surveillance

Verified

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…

1 source-linked fact

Checked 2026-08-26

Open details →

D24

Advertising, claims & promotion

Verified

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…

2 source-linked facts

Checked 2026-08-26

Open details →

D25

Submission communications & appeal

Verified

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…

1 source-linked fact

Checked 2026-08-26

Open details →

Government fees

Full fee schedule (1 lines) →

Medsafe registration fees in NZD · reviewed 2026-08-25

Fee line	Amount	Provenance
WAND database notification (all device classes)	NZD 0	Verified

Registration timeline

Full registration timeline →

Medsafe (Ministry of Health) (Medsafe) review clocks and planning ranges · 4-class (I, IIa, IIb, III) — WAND notification-based system classification

Class / pathway	Review clock	Planning total	Provenance
All devices (WAND notification)(Notification to the Web Assisted Notification of Devices (WAND) database) Zero regulator decision time, at every risk class. WAND is a database, not an approval: there is no pre-market assessment, no fee, and no certificate, and a completed notification is confirmed on submission once the sponsor signs the declaration under reg 7 The well-known 30 working days is a duty on the sponsor, not a review period. Reg 6 requires the device to be notified within 30 working days of becoming its sponsor, which Medsafe reads as running from the date the device first arrives in New Zealand — so supply may lawfully begin before the notification is filed Reg 8 requires notified information to be corrected within 10 working days of it ceasing to be correct, which is also how a change of sponsor is handled: the outgoing sponsor marks entries obsolete and the incoming one re-notifies Reg 10 forbids any statement implying that notification is an endorsement of safety or suitability, and reg 14 makes contravention of regs 6, 8, 9 or 10 an offence carrying a fine of up to $500	0 days	1-2 months	Verified

Class / pathway

Review clock

Planning total

Provenance

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

Zero regulator decision time, at every risk class. WAND is a database, not an approval: there is no pre-market assessment, no fee, and no certificate, and a completed notification is confirmed on submission once the sponsor signs the declaration under reg 7

The well-known 30 working days is a duty on the sponsor, not a review period. Reg 6 requires the device to be notified within 30 working days of becoming its sponsor, which Medsafe reads as running from the date the device first arrives in New Zealand — so supply may lawfully begin before the notification is filed

Reg 8 requires notified information to be corrected within 10 working days of it ceasing to be correct, which is also how a change of sponsor is handled: the outgoing sponsor marks entries obsolete and the incoming one re-notifies

Reg 10 forbids any statement implying that notification is an endorsement of safety or suitability, and reg 14 makes contravention of regs 6, 8, 9 or 10 an offence carrying a fine of up to $500

0 days

1-2 months

Verified