NZ Regulations

Australia and New Zealand have postponed indefinitely any moves towards the formation of a joint trans-Tasman agency for the regulation of medical products. Existing arrangements in New Zealand will continue to apply. 

New Zealand currently has similar requirements to those of Australia for Prescription and Over The Counter Medicines. New medicines and related products, and changed medicines and related products cannot be marketed in New Zealand without prior consent. Data to establish the quality, safety & efficacy of the product for the purposes for which it is to be used must be submitted to MEDSAFE for evaluation before consent can be granted.

There is a notification database called New Zealand Web Assisted Notification of Devices (NZ WAND) , which applies for Medical Devices. The Medicines (Database of Medical Devices) Regulations 2003 came into force on 1 January 2004. Under these regulations, sponsors supplying medical devices in New Zealand or exporting medical devices are required to complete a notification in the WAND database. Sponsors and manufacturers have one month from the date of supply to notify the information on the WAND database.

Another notification database called the Dietary Supplements Database  has commenced for Complementary Medicines which are regulated as dietary supplements in New Zealand. 

Getting Started...

If you need assistance or advice on registering a medical product or satisfying other requirements in New Zealand. Please complete the Free Online Consultation Form.