Medical Device Regulatory Requirements in New Zealand

Regulatory Authority New Zealand Medicines and Medical Devices Safety Authority
Regulatory Authority Website Link Click Here
Device Classification I, IIa, IIb and III, AIMD (Active Implantable Medical Device)
Medical Device Regulations Medical Device Legislation Database of Medical Devices) Regulations 2003 (SR 2003/325) | Click Here
Device Classification Guidelines Risk Classification of Medical Devices | Click Here
Registration Timeline It has to be notified within 30 calendar days of commercialization.
Requirement of Authorized Representative Yes
Language Requirement Labels must be in English Language
Labeling Requirements

Labelling of Medical Devices

| Click Here
Clinical Trials Information

Conducting Medical Device Clinical Trials in New Zealand

| Click Here
Database Web Assisted Notification of Devices (WAND) Database | Click Here
Fees for Submission

Schedule of Fees Payable under the Medicines Act 1981 (Effective from 1 July 2022)

| Click Here
Declaration of Conformity

The declaration required by regulation 6(b) is a declaration that—
(a) the medical device or kind of medical device, as the case requires, in respect of which information is supplied, is a medical device or kind of medical device (within the meaning of these regulations) and is correctly classified in accordance with these regulations:
(b) the medical device or kind of medical device, as the case requires, will only be recommended by the sponsor for use for its intended purpose:
(c) the information supplied by, or on behalf of, the sponsor under regulation 6(a) is accurate and complete.
Reportable Incidents

An adverse event meets all of the following criteria.

  1. An event must have occurred. Typical events are:
    • A malfunction or deterioration in the characteristics or performance.
    • An unexpected, incorrect or out of specification result or outcome.
    • An inaccuracy in the labelling, instructions for use and/or in promotional materials. Inaccuracies include omissions and deficiencies.
    • The discovery of a serious public health threat.
    • Use error.
  2. An identified medical device is associated with the event.
  3. The event led to or could have led to injury to a patient or other person.
| Click Here
Adverse Event Reporting Timelines

Death or Serious Injury

  • Submit an initial report as soon as possible, within 10 calendar days.
Recalls

Product Recall Information

| Click Here
Advertising and Promotions

Advertising of Medical Devices

| Click Here
Additional Information

Devices must be notified to the WAND database within 30 calendar days of a person or organisation becoming the sponsor of the device.
Contact Phone (04) 496 2000
Contact Email askmedsafe@health.govt.nz
Contact Address Medsafe Ministry of Health Ground Floor Reception 133 Molesworth Street Thorndon Wellington 6011
Disclaimer: This website sources information from regulatory authorities and aims for accuracy, but regulations may change without notice. Users are advised to verify details with relevant authorities before making compliance decisions. We are not responsible for errors, omissions, or outdated content.

The above information is last updated on 31/Aug/2025

If you found this helpful, consider supporting by buying me a coffee ☕
Every little bit counts!