Information for Medical Device Suppliers
The Web Assisted Notification of Devices (WAND) Database
Notification of IVDs to the WAND Database
IVDs are medical devices that are currently exempt from mandatory notification to the WAND database by order of the Director-General of Health. However IVDs may be voluntarily notified to the database.
Risk classification for IVDs
GMDN Codes for IVDs
Step 1 - Getting Access to WAND
Step 2 - Entering Manufacturers into WAND
Step 3 - Notifying devices to WAND
Further Assistance
Risk Classifications for IVDs
Currently, Medsafe does not recognise any IVD risk classification model and has therefore established a single risk classification for all IVDs. Risk classification is selected from a drop down list of options when notifying a device. When notifying IVDs to the WAND database sponsors should use the risk classification of IVD.
GMDN Codes for IVDs
Global Medical Device Nomenclature (GMDN) codes are required to be used to identify types of medical devices notified to the WAND database. The GMDN system includes a wide range of codes specific to IVDs. Manufacturers of IVDs should be able to provide sponsors with the correct GMDN codes for their devices. Sponsors should obtain both the 5-digit code and descriptor for the GMDN code from the manufacturer.
External Link to the GMDN Agency website at gmdnagency.org
Step 1 - Getting Access to WAND
Access to the WAND database is restricted to sponsors of medical devices. New sponsors need to apply for access to the WAND database to begin the notification process. There is no public access to the WAND database.
Link to Definition of a Sponsor
Link to Accessing the WAND Database
Download an Access to WAND Application Form
(Microsoft Word document 94 KB)
Step 2 - Entering Manufacturers into WAND
Before a device notification can be made to WAND, the manufacturer's details must be available in the database. Sponsors must supply Medsafe with the manufacturer's details so they can be added to the database. Processing of new manufacturers into the database can take up to 10 working days.
Link to Notifying a New Manufacturer to WAND
Step 3 - Notifying Devices to WAND
Notifying a new device to the WAND database is a simple process but one that requires the sponsor to obtain information from the manufacturer before commencing. This guide describes notifying a basic (non-medicated, non-formulated) medical device.
Link to Submitting a New Device Notification
Further Assistance
For further assistance with submitting new WAND device notifications please refer to the WAND User Manual
Download the WAND User Manual (Adobe PDF document 292 KB)
Page last updated 10 May 2011