Medical Devices

Web Assisted Notification of Devices (WAND)

New regulations - the Medicines (Database of Medical Devices) Regulations 2003 came into force on 1 January 2004.  Under these regulations, sponsors supplying medical devices in New Zealand or exporting medical devices are required to complete a notification in the WAND database.  Sponsors and manufacturers have one month from the date of supply to notify the information on the WAND database.

New medical device legislation will be  introduced in New Zealand on the formation of the proposed Joint Agency.

• Presentations given at the Medical Device Regulatory Seminars held in Christchurch and Auckland between 28 November-2 December 2005:
  
  General Session

  1. An Update on the Trans-Tasman Agency and Regulatory Scheme (Adobe Acrobat document 73KB)

  2. General Session - WAND Update (Adobe Acrobat document 289KB)

  3. Elements of the Regulatory Framework for Medical Devices (Adobe Acrobat document 237KB)

  4. The Assessment Process and Product Licensing (Adobe Acrobat document 157KB)

  5. Where to From Here? (Adobe Acrobat document 123KB)

  Manufacturers Session

  1. Introduction and WAND information (Adobe Acrobat document 24KB)

  2. The Roadmap for Manufacturers (Adobe Acrobat document 518KB)

  IVD Session

  1. Introduction (Adobe Acrobat document 40KB)

  2. 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:
  1. Recalls & Alerts . Who is responsible? (Microsoft Powerpoint presentation 339KB)
  2. 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.)
  1. The Trans Tasman Therapeutic Products Scheme (Microsoft Powerpoint presentation 136KB)
  2. Introduction - Proposed Requirements for In-vitro Diagnostic Devices (Microsoft Powerpoint presentation 694KB)
  3. The Global Position on IVD Regulation (Microsoft Powerpoint presentation 218KB)
  4. Essential Principles and Standards (Microsoft Powerpoint presentation 268KB)
  5. Classifying your IVD (Microsoft Powerpoint presentation 163KB)
  6. Proposed Regulatory Framework for IVDs - Conformity Assessment Procedures (Microsoft Powerpoint presentation 172KB)
  1. The Application Process (Microsoft Powerpoint presentation 143KB)
  2. Transition Arrangments (Microsoft Powerpoint presentation 220KB)

  
  

• About the Medicines (Database of Medical Devices) Regulations 2003
  - Letter sent to device suppliers in Nov 2003
  - Exemption for in-vitro diagnostic devices
  
  
• About WAND 
  - 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.
  
  
• To enter, edit or view an entry in WAND
  
  
• Application for Access Rights to WAND
  
  
• User Management System
  
  
• Subscribe to receive weekly e-mail updates on regulatory matters from Medsafe