Table of Contents
Medical Device Registration in New Zealand
Click here to visit New Zealand Medsafe website.
Requirements as below:
- Technical File summary
- Essential Requirement Checklist
- Risk Management File
- Usability Report
- Clinical Evaluation
- Biocompatibility Evaluation
- Information For Safety (Labels/IFU/Implant leaflet/card etc)
- Sterilization Validation
- Stability / shelf life
- Transport Validation
Click here to contact us for more information and our service on for New Zealand.
