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 (Database of Medical Devices) Regulations 2003
Official Language:
English
Classification:
Class I, IIa, IIb, III and AMIND
Medical Device Registration in New Zealand:
- 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