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New Zealand

Medical Device Registration in New Zealand

Ministry of Health:     

Ministry of Health New Zealand

Regulatory Authority:          

New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE)

Medical Device Regulation:          

Medicines Act 1981

Medicines Regulation 1984

Medicines (Database of Medical Devices) Regulations 2003

Official Language:      

English

Classification:    

Class I, IIa, IIb, III and AMIND

Registration Process:

  • Medical Device registration is processed via the WAND (Web Assisted Notification of Devices) database
  • Determine the Device Classification
  • Appoint an Authorized Representative
  • Determine the product description as per the GMDN system
  • Premarket approval of medical devices is NOT necessary. However, the product must be listed on WAND within 30 days of commercialization

Documents Required:          

  • Information to be entered in the WAND database:
  • Device risk classification
  • Manufacturer information
  • Sponsor information
  • Product description as per GMDN
  • UDI (for Class III and AIMD)
  • Product Information
  • QMS or Conformity Assessment certificate
  • CE Mark
  • Declaration of Conformity

Post-market surveillance:  

  • Death and Serious Injury – 10 calendar days
  • Minor injury – Initial report within 10 working days + Final report within 120 calendar days
  • Quality Issue – Initial report within 10 working days + Final report within 120 calendar days

Applicable QMS:          

ISO 13485

Registration Timeline:         

The product must be listed on WAND within 30 days of commercialization

Authorized Representative:          

Yes, Sponsor

License Validity:          

Does not expiry

Special Notes:    

e-IFUs are acceptable. Labels and IFUs should be in English

Want to know more about this registration process?