Decoding New Zealand’s Medical Device Regulations
The medical device Regulatory framework in New Zealand is built to ensure that medical devices sold in the country are safe and fit for their intended purposes. The Medicines Act, 1981 and its revisions, the Medicines Regulations, 1984, and the Medicines (Database of Medical Devices) Regulations, 2003 govern New Zealand’s medical device Regulatory system.
Medical devices must be reported to the Web Assisted Notification of Devices (WAND) database, which is managed under the Regulatory framework of the New Zealand Medicines and Medical Devices Safety Authority (Medsafe).