Web Assisted Notification of Devices (WAND)
Sponsor Access to WAND and Other Information
**Important Update on the Status of the New WAND Database** read more
**Important Changes on the WAND System Occurring 29 October 2008** read more
WAND
- To submit a new WAND notification login
- To view a
notification (submitted before 28 October 2008) in Read-Only WAND
(Note: please enter your User ID, e.g. Medsafe_12345 and User password) - Master Account
Access and User Management for Read-Only WAND
(Note: please enter your Master User ID, e.g. Master12345 and Master password) - How to manage your Master account access for user management for Read-Only WAND
Forms
- New Zealand WAND Access
- Sponsor Details Update Form
- Change of company sponsorship for
medical devices currently listed on WAND
- Transfer of Sponsorship (Form A) (Microsoft Word 38KB)
- Acceptance of Sponsorship (Form B) (Microsoft Word 36KB)
Instructions/Help/FAQs
- Instructions for the Interim WAND Notification Process (29 October 2008-2009) (Adobe Acrobat (pdf) document 101KB)
- Questions/Queries Concerning WAND: FAQs (Adobe Acrobat (pdf) document 32KB)
- Deletion of a Notification
- Contact details of the DART (Device Assistance for Regulatory Transition) Team: Email: dart@moh.govt.nz
- Subscribe/Unsubscribe to DART Team Newsletters
- Subscribe to receive weekly e-mail updates on regulatory matters from Medsafe
- 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.
- DART Newsletters
- 6th DART Newsletter (Adobe Acrobat (pdf) document 71KB)
- 5th DART Newsletter (Adobe Acrobat (pdf) document 69KB)
- 4th DART Newsletter (Adobe Acrobat (pdf) document 55KB)
- 3rd DART Newsletter (Adobe Acrobat (pdf) document 62KB)
- 2nd DART Newsletter (Adobe Acrobat (pdf) document 57KB)
- 1st DART Newsletter (Adobe Acrobat (pdf) document 55KB)
- July 2008 Presentations made at the "Healthcare Materials Management and Medical Industry Association of NZ 4th Combined Annual Conference 28th - 30th July 2008
- MIANZ presentation-When Things Aren't Right (Adobe Acrobat (pdf) document 420KB)
- WAND Regulatory Issues 08 (Microsoft Powerpoint document 163KB)
- June 2007 WAND workshop presentation (Microsoft Powerpoint 455 KB)
- November 2005 Medsafe, MIANZ and the TGA Roadshow
- 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)
- October 2005 Presentations given at the Healthcare Materials
Management & Medical Industry Association of New Zealand 1st Combined Annual
Conference, 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)
- December 2004 Presentations from the In-Vitro Diagnostics Seminar
(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)
- November 2003 Letter sent to device suppliers in Nov 2003