Regulatory Requirements for Medical Devices in New Zealand

1. Overview and Legal Framework

Medical devices supplied in New Zealand are regulated under the Medicines Act 1981 and the Medicines (Database for Medical Devices) Regulations 2005. The Act prohibits the supply of devices that do not conform to essential principles of safety and performance, unless exempted. Sponsors (persons responsible for placing the device on the market) must ensure compliance before supply. Source: https://www.medsafe.govt.nz/regulatory/DevicesNew/3-6RegulatoryRequirements.asp

Key requirements include conformity assessment, labelling, advertising controls, notification to the Web Assisted Notification of Devices (WAND) database, and post-market obligations such as adverse event reporting. Source: https://www.medsafe.govt.nz/regulatory/DevicesNew/3-6RegulatoryRequirements.asp

2. Essential Principles of Safety and Performance

All medical devices must comply with the essential principles set out in the Medicines (Essential Principles for Safety and Performance) Regulations. These cover general requirements (e.g., risk reduction, design for intended use) and specific aspects such as chemical, physical and biological properties, infection and microbial contamination, construction and environmental properties, and information supplied by the manufacturer. Source: https://www.medsafe.govt.nz/regulatory/DevicesNew/3-6RegulatoryRequirements.asp

Compliance is demonstrated through conformity assessment procedures appropriate to the device's risk classification. Source: https://www.medsafe.govt.nz/regulatory/DevicesNew/3-6RegulatoryRequirements.asp

3. Conformity Assessment and Recognised Standards

Manufacturers must apply conformity assessment procedures based on risk (Class I, IIa, IIb, III for non-IVD; low to high individual risk for IVD). Acceptable evidence includes declarations of conformity supported by recognised standards (harmonised with ISO/IEC standards) or equivalent overseas approvals from jurisdictions with comparable regulatory systems (e.g., Australia, EU, USA, Canada, Japan). Source: https://www.medsafe.govt.nz/regulatory/DevicesNew/3-6RegulatoryRequirements.asp

For higher-risk devices, third-party certification (e.g., from notified bodies) may be required. Sponsors must retain technical documentation and declarations for inspection. Source: https://www.medsafe.govt.nz/regulatory/DevicesNew/3-6RegulatoryRequirements.asp

4. Labelling and Instructions for Use

Labelling must be in English and include information such as device description, intended purpose, instructions for use, warnings, precautions, manufacturer details, batch/lot/serial number, and expiry date where applicable. Special requirements apply to sterile devices, custom-made devices, and those with measuring functions. Source: https://www.medsafe.govt.nz/regulatory/DevicesNew/3-6RegulatoryRequirements.asp

5. Advertising and Promotion

Advertising of medical devices to the public is restricted. Certain claims (e.g., implying treatment or cure of serious conditions) are prohibited. Advertisements must not mislead and must comply with the Medicines Act advertising provisions and the Therapeutic Products Advertising Code where applicable. Source: https://www.medsafe.govt.nz/regulatory/DevicesNew/3-6RegulatoryRequirements.asp

6. Notification to WAND Database

Before supplying a medical device in New Zealand, the sponsor must notify details to the WAND database, including device description, classification, GMDN code, sponsor details, and evidence of conformity. Notification is free and must be completed before first supply. Changes (e.g., sponsor transfer, discontinuation) must also be notified. Source: https://www.medsafe.govt.nz/regulatory/DevicesNew/3-6RegulatoryRequirements.asp

7. Post-Market Obligations

Sponsors must:

• Maintain distribution records
• Report adverse events and field safety corrective actions to Medsafe
• Conduct vigilance and post-market surveillance
• Cooperate with Medsafe investigations

Medsafe may issue alerts, recalls, or prohibitions if safety/performance issues arise. Source: https://www.medsafe.govt.nz/regulatory/DevicesNew/3-6RegulatoryRequirements.asp

8. Additional Notes

Exemptions apply to certain low-risk or custom-made devices, but sponsors remain responsible for safety. The regulatory system aligns closely with Australia's, facilitating trans-Tasman recognition of conformity assessments. Source: https://www.medsafe.govt.nz/regulatory/DevicesNew/3-6RegulatoryRequirements.asp

This framework ensures medical devices supplied in New Zealand meet acceptable safety and performance standards while supporting access to innovative technologies. Source: https://www.medsafe.govt.nz/regulatory/DevicesNew/3-6RegulatoryRequirements.asp