Regulatory Affairs

Key New Zealand legislation impacting medical devices

http://www.medsafe.govt.nz/regulatory/DevicesNew/2Legislation.asp

The Medicines (Database of Medical Devices) Regulations 2003 came into force on 1 January 2004. These Regulations require the Director General of Health to maintain a database ("WAND") of all medical devices supplied in New Zealand.

From that date, a sponsor (i.e. any New Zealand-based person or organisation that is manufacturing or importing medical devices for supply in New Zealand, or exporting medical devices) will be required to enter details into a medical device database within 30 days of commencing supply or export of a new medical device.

WAND is a notification database only, and is reliant only on information provided by sponsors about their products. Inclusion of a notification on WAND does NOT indicate approval or any other endorsement of the device by Medsafe.

The proposed Therapeutic Products and Medicine Bill to establish the Australia New Zealand Therapeutic Products Authority (ANZTPA) is on hold. New medical device legislation to establish a pre-registration and post-market process will be introduced into New Zealand in the near future.

For further information and obtain instructions for WAND notification click here