New Zealand Legislation: Regulations

7 Declaration

• The declaration required by regulation 6(b) is a declaration that—

  • (a) the medical device or kind of medical device, as the case requires, in respect of which information is supplied, is a medical device or kind of medical device (within the meaning of these regulations) and is correctly classified in accordance with these regulations:

  • (b) the medical device or kind of medical device, as the case requires, will only be recommended by the sponsor for use for its intended purpose:

  • (c) the information supplied by, or on behalf of, the sponsor under regulation 6(a) is accurate and complete.