Revised: 10 May 2011

Medical Devices

Regulatory Requirements for Sponsors

Sponsors of medical devices are required to meet all of the requirements of the Medicines Act 1981, the Medicines Regulations 1984, and the Medicines (Database of Medical Devices) Regulations 2003. This means more than just notifying a device to the WAND database.

Reg. 5 - Information required to be entered into the database

This Regulation requires the following information to be entered into the database;

• The risk classification of the device (as determined in Schedule 2 of the Regulations)
• The address of the registered office or principal place of business in New Zealand of the sponsor
• A contact telephone number or email address for the sponsor
• The address of the registered office or principal place of business of the manufacturer (whether in New Zealand or overseas)
• A contact telephone number or email address for the manufacturer
• The product description attributed to the device by the Global Medical Device Nomenclature (GMDN) system
• A product identifier for each Class III and Class AIMD medical device

This Regulation also describes the circumstances under which multiple medical devices can be notified as a single entry to the database.

Regulation 5 of the Medicines (Database of Medical Devices) Regulations 2003.

Reg. 6 - Information to be supplied by the Sponsor

This Regulation requires a sponsor to notify a medical device to the database within 30 working days of becoming the sponsor. The interpretation of the 30 working day period is that it commences from date that the device first arrives into New Zealand.

Regulation 6 of the Medicines (Database of Medical Devices) Regulations 2003.

Reg. 7 - Declaration

When notifying a device to the database the sponsor is declaring the following to be true;

• The product is a medical device as defined in the Regulations
• The sponsor has assigned the correct risk classification for the device
• The sponsor will only recommend the device for its intended purpose
• The information provided by the sponsor is accurate and complete

Regulation 7 of the Medicines (Database of Medical Devices) Regulations 2003.

Reg. 8 - Updated information to be supplied by the Sponsor

Should there be any change in the information notified to the database this Regulation requires the sponsor to correct that information within 10 working days of it ceasing to be correct. This means that should there be a change to the manufacturer, the sponsor details, or the device, the sponsor must update the information in the database within 10 working days.

Regulation 8 of the Medicines (Database of Medical Devices) Regulations 2003.

Reg. 9 - Sponsors must make arrangements to ensure compliance with Regs 5, 6, and 8

This Regulation requires a sponsor to put in place procedures necessary to ensure that it complies with Regulations 5, 6 and 8 of the Medicines (Database of Medical Devices) Regulations 2003.

Regulation 9 of the Medicines (Database of Medical Devices) Regulations 2003.

Reg. 10 - Prohibited Statements

This Regulation states that a manufacturer or sponsor of a medical device may not publish any statement that directly, or by implication, suggests that because a device is notified to the database, that this is an endorsement of the safety or suitability of that device by the Director-General or the Ministry of Health.

Regulation 10 of the Medicines (Database of Medical Devices) Regulations 2003.

Reg. 14 - Offences

This Regulation states that a sponsor that contravenes any of Regulations 6, 8, 9, or 10 commits an offence which is punishable by a fine not exceeding $500 on conviction.

Regulation 14 of the Medicines (Database of Medical Devices) Regulations 2003.