Medicines Act 1981
Overview
The Medicines Act 1981 is the primary legislation governing medical devices in New Zealand. Although originally designed for medicines, the Act was extended to cover medical devices — a decision that has increasingly shown its age as device technology has advanced far beyond what a 1981 law anticipated.
The Act defines what a medical device is, establishes Medsafe's powers, creates the framework within which the WAND Regulations operate, and sets out offences and penalties for non-compliance.
Key provisions relevant to medical devices
| Section | Content |
|---|---|
| Section 2 | Definitions — including the definition of "medical device" |
| Part 2 | Offences — including offences relating to supply of unsafe or non-compliant devices |
| Part 4 | Licensing — GMP licensing of manufacturers (for medicines; some device manufacturers) |
| Part 6 | General regulatory powers — Medsafe's powers of inspection and information gathering |
The Act is available in full at legislation.govt.nz.
Medsafe's powers under the Act
Medsafe can:
- Enter and inspect premises where medical devices are manufactured, stored, or sold
- Request documentation — including technical files, distribution records, and QMS records
- Seize devices that are unsafe or non-compliant
- Direct recalls — require a Sponsor to cease supply or recover devices
- Issue infringement notices for regulatory breaches
- Prosecute serious offences
Offences and penalties
Offences under the Medicines Act relating to medical devices include:
- Supplying a device without a required WAND notification
- Making a false or misleading WAND notification
- Supplying a device that does not comply with the Medicines Act requirements
- Failing to comply with a Medsafe direction
- Obstructing a Medsafe inspector
Penalties include fines and, for serious cases, imprisonment. The Act gives Medsafe significant enforcement flexibility.
Limitations of the Act for modern devices
The Medicines Act 1981 was not designed for:
- Software as a Medical Device
- AI-based diagnostics
- Complex combination products
- Modern clinical trial oversight for devices
- The UDI and traceability frameworks now standard internationally
These gaps are a primary driver of the Medical Products Bill currently being developed to replace it. See Medical Products Bill.