What is a medical device?
The legal definition of a medical device under the Medicines Act 1981 (New Zealand) and how Medsafe applies it in practice.
What is not a medical device?
Products and articles that fall outside the Medicines Act 1981 definition of a medical device in New Zealand.
Regulatory framework overview
An overview of how New Zealand regulates medical devices under Medsafe — the Medicines Act 1981, WAND, the Sponsor model, and the upcoming Medical Products Bill.
How NZ differs from Australia and the EU
Key differences between New Zealand's Medsafe framework and the Australian TGA and European EU MDR systems — practical implications for manufacturers and sponsors.
Who needs to comply?
Which parties have regulatory obligations under the Medicines Act 1981 — manufacturers, sponsors, importers, distributors, and healthcare providers.
Lifecycle of a medical device in NZ
A step-by-step overview of the regulatory lifecycle for a medical device in New Zealand — from pre-market through to recall or retirement.
Glossary of key terms
Key terms and definitions used in New Zealand medical device regulation under Medsafe and the Medicines Act 1981.