New Zealand Legislation: Regulations

6 Information and declaration to be supplied by sponsor

• A sponsor of a medical device must, within 30 working days of becoming the sponsor of the device,—

  • (a) ensure that the information required to be entered in the database under these regulations is received by the Director-General or other person who maintains the database on behalf of the Director-General; and

  • (b) provide to the Director-General or other person who maintains the database on behalf of the Director-General a declaration by the sponsor or an employee of the sponsor that complies with regulation 7.