Guidelines & Codes
Medical Device Standards
Companies Manufacturing Medical Devices in New Zealand
Companies manufacturing 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 device in Australia, the company needs to comply with ISO9001/EN46001 or ISO 13485. Other device manufacturers should be aware of ISO9002/EN46002 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:
Robert Jelas on (04) 819 6881 or e-mail robert_jelas@moh.govt.nz