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The WAND database was established by the Medicines (Database of Medical Devices) Regulations 2003 to collect information about medical devices supplied in New Zealand. It is a mandatory requirement for importers, exporters and local manufacturers to notify their medical devices to the database. WAND is not an approval system for medical devices.
There is no approval system for medical devices under the Medicines Act 1981. There is no mandatory requirement for medical devices to be approved by any medical device regulator prior to being supplied in New Zealand. Notification to the WAND database does not mean or imply that a medical device has been assessed by Medsafe in terms of quality, safety, efficacy, or performance. It is, though, a mandatory requirement for importers, exporters and New Zealand manufacturers to advise the Director-General of Health, via the WAND database, of the devices that are supplied here.
The WAND database holds information about all medical devices supplied in New Zealand and is used by Medsafe to respond to information about medical device safety issues. If there is a safety issue with a device the WAND database is used to identify all sponsors of that device.
Medsafe has a role to monitor post-market activity in relation to medical devices and to take action when required to ensure devices continue to meet legislative requirements with respect to safety. Medsafe used the information in WAND to identify sponsors of products when necessary in order to make contact when post market issues have been raised through international or local reports.
There are no charges associated with the database. All information is submitted free of charge to the WAND database.