New Zealand Regulatory Pathway Overview

A streamlined medical device entry framework

Medical devices in New Zealand are regulated by Medsafe, under the Medicines Act 1981 and the Medicines (Database of Medical Devices) Regulations 2003.

Unlike many other markets, the regulatory pathway focuses primarily on device notification rather than pre-market approval.
 

Key regulatory features

• No pre-market approval required for medical devices before commercialization
• Devices must be notified in the WAND database (Web Assisted Notification of Devices) to be legally supplied in New Zealand
• Listing must be completed within 30 days of placing the device on the New Zealand market
• WAND notification is free, and there is no licence or approval issued
• Notification requires only a device declaration under Regulation 7 of the Medicines (Database of Medical Devices) Regulations 2003
• Medsafe may request technical documentation if needed to verify device safety
   

Local sponsor requirement

Foreign manufacturers must appoint a New Zealand-based Sponsor, who acts as the local legal representative and is required to place medical devices on the New Zealand market. With its local presence, Qualtech enables manufacturers to establish this required local representation, ensuring a smoother and compliant entry into New Zealand.

The Sponsor is responsible for:

• Submitting device notifications to WAND
• Maintaining regulatory compliance
• Communicating with Medsafe when required
• Managing post-market obligations such as recalls, corrective actions, labelling, and advertising compliance

Sponsors must also ensure devices are safe, properly labelled, and compliant with relevant New Zealand regulations.
 

Globally familiar classification system

New Zealand follows the Global Harmonisation Task Force (GHTF) risk classification scheme, which is broadly aligned with regulatory models used in:

• European Union
• United States
• Australia

Medical devices are classified based on risk level and intended use, considering factors such as invasiveness, duration of contact, and impact on the patient.

The classification system includes:

• Class I – Low risk (e.g., basic or non-invasive devices)
• Class IIa – Low to medium risk
• Class IIb – Medium to high risk
• Class III – High risk (e.g., life-supporting or implantable devices)
• AIMD – Active implantable devices (highest risk)

Sponsors are responsible for determining the correct classification using rule-based criteria, and the highest applicable risk class must be applied.

Reference

Medsafe medical device regulation overview