Web Assisted Notification of Devices (WAND)
- To enter, edit or view an entry in WAND
- Application for Access Rights to WAND/Setting up E-Business Access Rights (Appendix 2 and 3 Forms)
- User Management System (activate/adjust your Master WAND account)
- Introduction to WAND (Microsoft Word document 130KB)
- WAND user
manual (Adobe Acrobat document 1,741KB)
If you have difficulty printing this document make sure the "Print as image" box is ticked. - Deletion of a Notification
- Change of Sponsor Rights to
Devices on WAND
- Transfer of Agency Rights (Form A) (Microsoft Word 38KB)
- Acceptance of Agency Rights (Form B) (Microsoft Word 36KB)
- Subscribe/Unsubscribe to DART Team Newsletters
- Subscribe to receive weekly e-mail updates on regulatory matters from Medsafe
- Questions/Queries concerning WAND: FAQs
- Contact details of the DART (Device Assistance for Regulatory
Transition) Team:
Email: dart@moh.govt.nz - WAND workshop presentation (Microsoft Powerpoint 455 KB)
- Other Helpful Links
Medical Device Definition, Post-market and Pre-market Information
The Medicines (Database of Medical Devices) Regulations 2003 came into force on 1 January 2004. These Regulations require the Director General of Health to maintain a database ("WAND") of all medical devices supplied in New Zealand.
From that date, a sponsor (i.e. any New Zealand-based person or organisation that is manufacturing or importing medical devices for supply in New Zealand, or exporting medical devices) will be required to enter details into a medical device database within 30 days of commencing supply or export of a new medical device.
ANZTPA is on hold new medical device legislation will be introduced in New Zealand on the formation of the proposed Joint Agency.
Archived information
This may be useful for reference but some information may no longer apply.
General Session
- General Session - WAND Update (Adobe Acrobat document 289KB)
- Elements of the Regulatory Framework for Medical Devices (Adobe Acrobat document 237KB
Manufacturers Session)
- Introduction and WAND information (Adobe Acrobat document 24KB)
- The Roadmap for Manufacturers (Adobe Acrobat document 518KB)
IVD Session
- Introduction (Adobe Acrobat document 40KB)
- The Proposed Regulatory Framework for IVDs (Adobe Acrobat document 185KB)
Presentations given at the Healthcare Materials Management & Medical Industry Association of New Zealand 1st Combined Annual Conference, 28 October 2005 at the Town Hall, Wellington Convention Centre:
- Recalls & Alerts . Who is responsible? (Microsoft Powerpoint presentation 339KB)
- Wand Update. Kits & Packs. Regulatory Impact for Importers, DHBs & Manufacturers. Are DHBs manufacturers? (Microsoft Powerpoint presentation 184KB)
Presentations from the In-Vitro Diagnostics Seminar held on 2 December
2004.
(Please note these are Microsoft powerpoint files. You will need either
Microsoft Powerpoint or Microsoft Powerpoint Viewer to view these files.
Please click here to download the
viewer.)
- The Trans Tasman Therapeutic Products Scheme (Microsoft Powerpoint presentation 136KB)
- Introduction - Proposed Requirements for In-vitro Diagnostic Devices (Microsoft Powerpoint presentation 694KB)
- The Global Position on IVD Regulation (Microsoft Powerpoint presentation 218KB)
- Essential Principles and Standards (Microsoft Powerpoint presentation 268KB)
- Classifying your IVD (Microsoft Powerpoint presentation 163KB)
- Proposed Regulatory Framework for IVDs - Conformity Assessment Procedures (Microsoft Powerpoint presentation 172KB)
- The Application Process (Microsoft Powerpoint presentation 143KB)
- Transition Arrangments (Microsoft Powerpoint presentation 220KB)