Medical Devices

Currently medical devices are required to be listed in Medsafe's WAND database within 30 days of being supplied in New Zealand or exported.  The regulatory controls on medical devices were expected to increase significantly on commencement of the Australia New Zealand Therapeutic Products Authority (ANZTPA).  However, there is now uncertainty regarding the future of ANZTPA.  It is expected that Medsafe will therefore introduce further regulatory controls on the distribution of medical devices.  We take every opportunity to provide input into proposed regulations and guidelines for medical devices and can provide advice on the regulatory controls as they become apparent.  We can provide:

• WAND and DEAL notifications
• Advice on best approach to transitioning devices to any new regulatory scheme
• NZ manufacturers of medical devices who wish to enter the larger markets of Australia, Canada and the European countries will require their products to be CE marked.  CARSL Consulting can assist with:
  • ISO 13485 preparation and implementation
  • Conformity Assessment and CE marking
  • Technical file development
  • Registration in Australia and Europe

We also have expertise to assist medical device manufacturers with:

• Sterilisation
• Clean Rooms
• GMP and SOP's
• Quality and Operational Manuals