Conformity evidence
No mandatory conformity assessment
Unlike Australia, the EU, the US, or the UK, New Zealand does not prescribe a formal conformity assessment procedure. There are no defined routes (no Annexes, no 510(k) equivalent). The Sponsor is simply responsible for ensuring evidence exists that the device is safe and performs as intended.
However, Medsafe may request technical documentation at any time — before, during, or after supply. If a Sponsor cannot produce adequate evidence on request, Medsafe can take enforcement action.
Accepted overseas evidence
Medsafe has confirmed it accepts the following as evidence of conformity with safety and performance requirements:
| Evidence type | Issuing body |
|---|---|
| CE certificate from a Notified Body | EU Notified Body |
| ARTG listing (Australian Register of Therapeutic Goods) | Australian TGA |
| 510(k) clearance, PMA approval, or De Novo order | US FDA |
| Medical Device Licence | Health Canada |
If a device holds any of these, this is generally considered strong evidence that the device meets safety and performance standards acceptable in New Zealand.
What if there is no overseas clearance?
Devices that have not been cleared or approved by any major overseas regulator can still be supplied in New Zealand. However, the Sponsor and manufacturer must hold:
- A technical file or design dossier documenting the device
- Risk management records (ideally aligned with ISO 14971)
- Clinical or performance evidence — clinical data, literature review, or pre-clinical testing
- Quality management system records (ideally aligned with ISO 13485)
- Labelling and IFU meeting GHTF/SG1/N43:2005
The standard of evidence expected is proportionate to the device's risk class — Class I devices require minimal documentation while Class III or AIMD devices require comprehensive clinical evidence.
When Medsafe requests documentation
Medsafe may request technical documentation:
- During a targeted audit or market surveillance sweep
- In response to an adverse event report
- Following an international safety signal
- As part of an investigation into a Sponsor or manufacturer
Sponsors must respond to Medsafe information requests within the timeframe specified. Refusing or failing to respond is an offence under the Medicines Act 1981.
Good practice recommendation
Even though no specific documentation format is mandated for NZ, Sponsors and manufacturers supplying higher-risk devices should maintain documentation aligned with:
- ISO 13485 — Quality management systems for medical devices
- ISO 14971 — Risk management for medical devices
- GHTF/SG1/N011 — Summary Technical Documentation (STED) for demonstrating conformity
This ensures that documentation is also suitable for other markets and meets Medsafe's expectations if requested.