Legislation Governing Medical Devices in New Zealand

1. Primary Legislation

Medical devices in New Zealand are regulated primarily under the Medicines Act 1981 and the Medicines Regulations 1984. https://www.medsafe.govt.nz/regulatory/DevicesNew/2Legislation.asp There is currently no separate, dedicated legislation for medical devices, unlike in many other jurisdictions. Devices are treated as a subset of therapeutic products under the Medicines Act framework. https://www.medsafe.govt.nz/regulatory/DevicesNew/2Legislation.asp

2. Definition and Scope

Under section 2 of the Medicines Act 1981, a medical device is defined as any instrument, apparatus, appliance, material, or other article (including software) intended for human use for purposes such as diagnosis, prevention, monitoring, treatment, or alleviation of disease or injury. https://www.medsafe.govt.nz/regulatory/DevicesNew/2Legislation.asp The definition aligns closely with international standards (e.g., those of the IMDRF/GHTF).

3. Key Regulatory Requirements

Devices must comply with the essential principles of safety and performance, as specified in notices issued under section 36 of the Medicines Act. https://www.medsafe.govt.nz/regulatory/DevicesNew/2Legislation.asp These principles cover aspects such as:

• Risk reduction
• Chemical, physical, and biological properties
• Infection and microbial contamination control
• Construction and environmental properties
• Information supplied by the manufacturer (labelling, instructions for use)

Compliance is demonstrated through conformity assessment procedures, often referencing harmonized standards. https://www.medsafe.govt.nz/regulatory/DevicesNew/2Legislation.asp

4. Classification System

Medical devices are classified into four risk-based classes (I, IIa, IIb, III) in line with international practice (e.g., EU MDD/AIMDD or IMDRF recommendations). https://www.medsafe.govt.nz/regulatory/DevicesNew/2Legislation.asp Classification determines the level of regulatory scrutiny and conformity assessment required.

• Class I — Low risk (e.g., non-sterile dressings)
• Class IIa — Low-medium risk (e.g., contact lenses)
• Class IIb — Medium-high risk (e.g., infusion pumps)
• Class III — High risk (e.g., heart valves, implantable devices)

5. Conformity Assessment and Notices

Sponsors must ensure devices meet the essential principles via appropriate conformity assessment. https://www.medsafe.govt.nz/regulatory/DevicesNew/2Legislation.asp Medsafe issues notices under sections 35, 36, and 105 of the Medicines Act to specify:

• Standards and conformity assessment requirements
• Exemptions or special provisions
• Transitional arrangements

These notices are published in the New Zealand Gazette and on the Medsafe website. https://www.medsafe.govt.nz/regulatory/DevicesNew/2Legislation.asp

6. Enforcement and Compliance

Medsafe enforces compliance through post-market surveillance, audits, and investigations under section 38 of the Medicines Act. https://www.medsafe.govt.nz/regulatory/DevicesNew/2Legislation.asp Non-compliance can result in prohibition of supply, seizure, or prosecution.

7. Future Developments

The Medicines Act framework for devices is under review, with potential future reforms to introduce dedicated medical device legislation or adopt a more comprehensive regulatory scheme aligned with international models (e.g., similar to Australia’s Therapeutic Goods Act). https://www.medsafe.govt.nz/regulatory/DevicesNew/2Legislation.asp

This legislative approach ensures medical devices in New Zealand meet acceptable safety, quality, and performance standards while facilitating access to innovative technologies. https://www.medsafe.govt.nz/regulatory/DevicesNew/2Legislation.asp