Medicines (Database of Medical Devices) Regulations 2003

5 Information required to be entered in database

• (1) The following information must be entered into the database in respect of each medical device that is not an exempt medical device:

  • (a) the risk classification of that device:

  • (b) the name of the manufacturer and the sponsor of that device, together with—

    • (i) the address of the registered office or principal place of business in New Zealand of the sponsor; and

    • (ii) the address of the registered office or principal place of business of the manufacturer (whether in New Zealand or overseas); and

    • (iii) a contact telephone number or email address for the manufacturer and the sponsor:

  • (c) the product description attributed to the device by the Global Medical Device Nomenclature System (GMDNS).

  (2) A unique product identifier for each Class III and Class AIMD medical device that is not an exempt medical device must be entered into the database.

  (3) Despite subclause (1), if a particular sponsor is the sponsor of 2 or more medical devices, it is only necessary to enter information in respect of each kind of device (instead of in respect of each device) for which the sponsor is responsible, if each of the devices of the same kind—

  • (a) was made by the same manufacturer; and

  • (b) has the same GMDNS code; and

  • (c) has the same risk classification; and

  • (d) is a Class I, Class IIa, or Class IIb medical device.

  (4) For the purposes of subclause (2), a unique product identifier for a medical device is a trade name or brand name, combined if the Director-General so requires, with a form of product identification.

  (5) For the purposes of subclause (3), 2 or more medical devices are of the same kind if those devices are—

  • (a) substantially similar to one another; and

  • (b) designed to be used in the same way and for the same purpose.