Revised: 10 May 2011
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.
This Regulation requires the following information to be entered into the database;
This Regulation also describes the circumstances under which multiple medical devices can be notified as a single entry to the database.
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.
When notifying a device to the database the sponsor is declaring the following to be true;
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.
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.
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.
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.