Information for Medical Device Suppliers
The Web Assisted Notification of Devices (WAND) Database
For medical devices to be legally supplied in New Zealand they must be notified to the WAND database. Notification of medical device information to the WAND database is free and there are no on-going fees. Devices must be notified to the WAND database within 30 calendar days of a person or organisation becoming the sponsor of the device. A sponsor is a person or organisation that imports or exports a device or that manufactures or arranges the manufacture of a device in New Zealand. The notification of medical devices to the WAND database does not constitute an approval process. However it is mandatory so the Director-General of Health has details about the medical devices supplied in this country. The information is confidential to the Ministry of Health.
Sponsor Login to the WAND database
Glossary
Explanation of the WAND database
Definition of a Sponsor
Regulatory Requirements for Sponsors
Getting Access to the WAND Database
Quick Reference Guides for WAND Processes
Risk Classification of Medical Devices
Exempt Medical Devices
In-Vitro Diagnostic (IVD) Devices
User Manual for WAND
Glossary
Understand the language of the WAND database. To comply with the Act and the
Regulations it is necessary to understand what is meant by key words and
phrases.
Glossary of Medical Device Terms
Explanation of the WAND database
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.
Explanation of the role and structure of the WAND database
Definition of a Sponsor
The Sponsor is the New Zealand entity - importer, exporter or local
manufacturer - that has the legal responsibility for a medical device supplied
in New Zealand. This responsibility includes ensuring that medical devices are
notified to the WAND database in accordance with the Regulations.
Explanation of who/what is a medical device sponsor
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.
Details of the information required
Getting Access to the WAND database
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.
Instructions for applying for access to WAND
Quick Reference Guides for WAND Processes
Sponsors are required to input and maintain information about themselves and
their devices into the WAND database. Basic guidance for most processes is
linked to this page. For more detailed information about these processes
download a copy of the WAND User Manual.
Quick Reference Guides for WAND processes
Risk Classification of Medical Devices
Medical devices are rated by their potential risk from Class I (low) to Active
Implantable Medical Device (AIMD, high). The Regulations require a sponsor to
determine the correct risk classification of its medical devices. Recent or
planned changes to risk classification systems in Europe and Australia mean
there are now differences between risk classifications in those regulatory
regimes and New Zealand.
Explanation of the New Zealand risk classification system
Exempt Medical Devices
Some types of medical devices are exempt from notification to the WAND
database. These exemptions are specified in Schedule 1 of the Regulations. The
Director-General of Health may also declare certain types of devices exempt.
Explanation of what types of medical devices are exempt
In-Vitro Diagnostic (IVD) Devices
IVDs are medical devices that are currently exempt from notification to the
WAND database by order of the Director-General of Health. However IVDs may be
voluntarily notified to the database
Instructions for notifying IVDs to WAND
User Manual for WAND
Download the WAND User Manual (Adobe PDF
document 297 KB)
Page last updated 17 May 2011