Medical Devices
Regulatory Statement to Foreign Government
A Regulatory Statement to Foreign Government is a statement issued by Medsafe, confirming that a medical device has been notified to the Web Assisted Notification of Devices (WAND) database, in compliance with the Medicines (Database of Medical Device) Regulations 2003.
New Zealand legislation does not require pre-market assessment of medical devices; however, a Sponsor of a medical device in New Zealand must notify the device to the Web Assisted Notification of Devices (WAND) database within 30 days of becoming the sponsor. For further information please see the Medsafe website at www.medsafe.govt.nz.
The notification of a device to the WAND database does not constitute approval or endorsement of the safety or efficacy of a medical device by Medsafe or any other regulatory body.
Medsafe can provide Regulatory Statements to Foreign Governments to a NZ Sponsor upon request. This cost of this service is $135 NZD (GST inclusive).
To request a Regulatory Statement to Foreign Government, please email the DART team (dart@moh.govt.nz) and include your 5 digit Sponsor ID and the WAND number of each medical device notification on WAND to be included in the statement.