New Zealand
New Zealand is a small but advanced market, with a well-structured healthcare system and openness to innovative medical devices.
Do you require help or further information?
Contact us! We are happy to advise you:
Regulatory Framework
The regulatory authority is Medsafe, an agency of the Ministry of Health.
Device Classification:
- Class I: Low risk
- Class IIa, IIb: Moderate risk
- Class III: High risk
Specific Local Requirements
| Language | Documentation in English. |
| Local Representative | Not mandatory. |
| Certifications | CE, FDA, and TGA certifications are accepted. |
Challenges and Operational Advice
- Self-certification based system: Post-market surveillance is strict.
- Periodic updates: It is necessary to keep information up to date on the WAND portal.
Why Choose ISEMED
- Regulatory Support
Assistance with preparation and management of notifications on the WAND system. - International Expertise
Knowledge of requirements to facilitate market entry.
FAQ
- Is a local representative required? No.
- Documentation language? English.
- Registration duration? Unlimited, with periodic updates.