New Zealand medicine and medical device safety authority is in charge of the registration process of medical and IVD devices in New Zealand.  A sponsor of a medical device sold in the New Zealand market is responsible to ensure the device has already been approved either by the US FDA and/or has been CE marked per the relevant EU MD Directives.

Web Assisted Notification of Devices (NZ WAND) is used for notifying MEDSAFE about devices currently marketed in New Zealand.  Our country specific (*) regulatory services in New Zealand include:

Medical Device Specific regulation strategy reports, Medical Device Registration with MEDSAFE, Australia Sponsor Representation for Medical Device manufacturers, Wand registration as well as Arazy Group’s unique line of GlobaR - Global Regulatory Hub™ products.

GlobaR Dossier™
GlobaR - One World Process™
GlobaR Submission Center ™
Universal Authorized Representative™
 
Please fill in the following form and submit your inquiry or discuss it with one of our online specialists. Let's get your products registered in New Zealand!

(*) New Zealand Regulatory Affairs services are part of the diverse professional consulting services provided by Arazy Group and can be found thorough this web site and inquired on through our form or online chat service.