REGULATORY AUTHORITY: New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE)
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.
SPECIAL REQUIREMENT: Depending on the nature and use of the products. Electrically powered devices may be regulated by the Energy Safety Service, irradiating apparatus by the National Radiation Laboratory, devices containing hazardous substances by Environmental Protection Authority, and devices using radiocommunications function by Radio Spectrum Management.
LOCAL FEES (New Application): Free of charge.
LOCAL FEES (Manufacturer): Not applicable
LICENSE VALIDITY: No validity. However, any changes must be notified within 10 working days of it ceasing to be accurate or complete.
LICENSE TRANSFER: Changing the sponsor of a medical device in New Zealand is possible.
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: Not applicable.
Other Oceania Countries: Australia