New Zealand Legislation: Regulations
Regulations are laws made under Acts
This note is not part of the regulations, but is intended to indicate their general effect.
These regulations, which come into force on 1 January 2004, establish a requirement for the Director-General of Health to establish a database of information about medical devices. The regulations impose obligations on certain people (sponsors of medical devices) to supply information necessary for the Director-General to establish and maintain the database, and to make declarations concerning the information that is supplied. Failure to comply with certain obligations under the regulations is an offence punishable on summary conviction by a fine not exceeding $500. The regulations also set out rules to be applied in determining the risk classifications that apply to medical devices.