New Zealand Authorized Representative

A ‘sponsor’, is

• An entity in New Zealand responsible for exporting or coordinating the export of the device from New Zealand;
• An entity in New Zealand responsible for importing or coordinating the import of the device into New Zealand;
• An entity in New Zealand involved in the manufacture of the device within New Zealand or coordinating manufacturing by another party for distribution, either within New Zealand or internationally.

Responsibilities of a Medical Device Sponsor

• Upon becoming a sponsor of a medical device, it is mandatory to:
• Ensure timely submission of required information for inclusion in the relevant database as per regulatory guidelines within 30 working days.
  • Furnish a declaration to the Director-General or their appointed personnel responsible for maintaining the database.
• Obligation for Updated Information by the Sponsor:If any details pertaining to a medical device or category of medical device recorded in the database become inaccurate or incomplete due to various factors such as changes in circumstances or certifications, the sponsor must:
  • Notify the Director-General or designated personnel maintaining the database within 10 working days from the occurrence of such inaccuracies or incompleteness.
  • Provide the corrected details or complete information promptly to ensure database accuracy and compliance with regulations.