REGULATORY AUTHORITY: New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE).
CLASSIFICATION SYSTEM:
- Medical Devices: I/Is – supplied sterile/Im – incorporating a measuring function/IIa/IIb/III/AIMD
- IVDs: MEDSAFE does not recognize any IVD risk classification model and has therefore established a single risk classification for all IVDs
TIMEFRAME:
- Medical Devices must be notified to the WAND database within 30 calendar days of a person or organization becoming the sponsor of the device.
- IVDs are currently exempt from mandatory notification to WAND, however, it may be voluntarily notified to the WAND database.
LICENSE VALIDITY: No validity. However, any changes must be notified within 10 working days of it ceasing to be accurate or complete.
LOCAL FEES (New Application): Free of charge.
LICENSE TRANSFER: Changing the sponsor of a medical device in New Zealand is possible. However, Medsafe cannot reassign an existing WAND notification; instead, the current sponsor makes notifications obsolete and the new sponsor re-notifies (within 10 working days).
AUTHORIZED REPRESENTATIVE: Manufacturers without local presence must appoint a sponsor based in New Zealand and must have a registered business or principal place of business in New Zealand to become their authorized representative and supply their products in New Zealand.
ADDITIONAL INFORMATION:
Medical devices marketed in New Zealand are not subject to pre-market approval or registration certificates. Instead, devices must be notified to the WAND database by the New Zealand sponsor after they are supplied or imported. There is no technical pre-market review or risk-based approval process; compliance relies on the manufacturer meeting Essential Principles of Safety and Performance and post-market controls. Certain devices may also fall under additional regulatory regimes (e.g. electrical safety, radiation, hazardous substances, radiocommunications), which must be complied with separately.
Other Oceania Countries: Australia
