Medical Device Regulatory Requirements in New Zealand
| Regulatory Authority |
New Zealand Medicines and Medical Devices Safety Authority |
| Regulatory Authority Website Link |
Click Here
|
| Device Classification |
I, IIa, IIb and III, AIMD (Active Implantable Medical Device) |
| Medical Device Regulations |
Medical Device Legislation
Database of Medical Devices) Regulations 2003
(SR 2003/325)
| Click Here
|
| Registration Timeline |
It has to be notified within 30 calendar days of commercialization. |
| Requirement of Authorized Representative |
Yes |
| Language Requirement |
Labels must be in English Language |
| Database |
Web Assisted Notification of Devices (WAND) Database
| Click Here
|
| Adverse Event Reporting Form |
Download |
| Additional Information |
Devices must be notified to the WAND database within 30 calendar days of a person or organisation becoming the sponsor of the device. |
Disclaimer: This website sources information from regulatory authorities and aims for accuracy, but regulations may change without notice. Users are advised to verify details with relevant authorities before making compliance decisions. We are not responsible for errors, omissions, or outdated content.
The above information is last updated on 09/Apr/2025