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New Zealand Medical Device Regulation

Regulatory authority: Medsafe (Ministry of Health) | System: WAND notification | Legislation: Medicines Act 1981 | Last reviewed: May 2026 | For reference only — not legal advice.

New Zealand regulates medical devices through Medsafe (New Zealand Medicines and Medical Devices Safety Authority), an agency within the Ministry of Health. The system is built on notification, not approval — most devices must be registered in the WAND database before supply, but there is no pre-market approval process comparable to the EU, US, UK, or Australia.

Regulatory Pathway Map​

Click a phase to expand — each card links to the relevant section of this guide.

Getting Started
What is a Medical Device?
Definition under the Medicines Act 1981 and WAND Regulations 2003 — scope and key terms.
Read definition →
Getting Started
Regulatory Framework Overview
Medsafe, WAND notification system, and how NZ differs from other markets.
View framework →
Getting StartedUnique to NZ
Who Must Comply? (Sponsor Model)
In New Zealand, a local Sponsor must notify and take responsibility for devices.
Check obligations →

Key Facts​

Regulatory bodyMedsafe, Ministry of Health
LegislationMedicines Act 1981 · WAND Regulations 2003
Market entryWAND notification (not approval)
Local rep requiredYes — New Zealand Sponsor carries full regulatory accountability
ISO 13485 required?No mandatory requirement — but strongly expected by good practice
UDI required?No — NZ has no UDI framework
Upcoming reformMedical Products Bill (expected to introduce formal approval pathways)

What This Site Covers​

  • Getting Started — definitions, who must comply, lifecycle, regulatory framework overview
  • Device Classification — the 22 classification rules, IVD classification, special device types
  • Market Entry (WAND) — WAND database, submission process, exempt devices, conformity evidence, changing sponsors
  • Sponsor Obligations — Sponsor role, appointing a Sponsor, technical documentation
  • Quality System — NZ's conformity evidence approach, sponsor quality obligations, GDP, Medical Products Bill changes
  • Post-Market — adverse event reporting, recalls and FSCAs, labelling and advertising, post-market surveillance
  • Special Topics — enforcement and compliance, SaMD and digital health, TTMRA and Australia, NZ in the global landscape
  • Legislation — Medicines Act 1981, WAND Regulations 2003, related legislation, Medical Products Bill
  • Resources — Medsafe guidance documents, useful links

What Makes New Zealand Unique​

New Zealand's model is built around three pillars — notification, Sponsor accountability, and post-market oversight — rather than pre-market approval. This creates important practical differences:

  • No pre-market approval for most devices — WAND notification is required, not an application reviewed by Medsafe
  • No ISO 13485 mandate — Medsafe does not require QMS certification upfront, but expects it can be demonstrated on request
  • Sponsor model — a NZ-based Sponsor holds all legal responsibility; the overseas manufacturer is not directly regulated by Medsafe
  • No UDI framework — NZ has no UDI requirement; the labelling standard is GHTF/SG1/N43:2005
  • Medical Products Bill — major reform underway to introduce formal approva