Updated: 10/23/00.

New Zealand currently does not require registration of medical devices. Instead, it relies on manufacturer compliance with established standards, enforced by post-market surveillance. By intent, the standards used usually correspond to those required by neighboring Australia, many of which are in turn equivalent to IEC or other internationally-recognized standards.

The New Zealand Medicines and Medical Devices Safety Authority, MedSafe, is a business unit of the Ministry of Health, and is the authority responsible for the regulation of therapeutic products in New Zealand. MedSafe was formed in 1998 from the previous Therapeutics Section of the Ministry of Health. While MedSafe retains a "watching brief" over medical devices, it currently does not have any direct regulatory role in approving medical devices under the country's governing law for medical products, the Medicines Act of 1981 (which focuses predominantly on pharmaceuticals).

Companies selling medical devices in New Zealand should be aware of the international standard of GMP required for their type of product. If the product is classified as a registrable medical device by Australia's Therapeutic Goods Administration (see http://www.health.gov.au/tga/), then the manufacturer needs to comply with ISO-9001/ EN- 46001 or ISO-13485. Other device manufacturers should be aware of ISO-9002/ EN-46002 or ISO-13488 if they manufacture sterile devices, bandages and dressings, soft contact lenses, implants, or dental restorative materials. Individual companies interested in further information should contact MedSafe (see below) with questions on specific types of devices.

Electronic medical devices are required to comply with April 1993 regulation NZECP-12 under the New Zealand Electrical Code of Practice (NZECP-12 may be viewed at website http://www.consumer-ministry.govt.nz/ess/Codes_of_practice.htm). These regulations are administered by the Ministry of Consumer Affairs (see below). As with GMP regulations, there is no pre-market verification or approval process in place mandating that manufacturers demonstrate their product's compliance prior to marketing, although purchasers and/or their agents may request or insist upon laboratory certificates as proof of compliance before consummating a purchase.

Medical devices sold in New Zealand should be labeled in English.

Contacts:

Mr. Trevor J. Nisbet
MedSafe
Ministry of Health of New Zealand
P.O. Box 5013
Wellington, New Zealand
Tel: 64-4-496-2000 / -2364
Fax: 64-4-496-2340
e-mail: trevor_nisbet@moh.govt.nz
Website: http://www.medsafe.govt.nz

Ministry of Consumer Affairs of New Zealand
Energy Safety Service
33 Bowen Street
P.O. Box 1473
Wellington, New Zealand
Tel: 64-4-472-0030
Fax: 64-4-460-1365
e-mail: safe.energy@med.govt.nz