Medsafe guidance documents
All official Medsafe guidance documents are published on the Medsafe website. Below are the key guidance pages and documents for medical device sponsors and manufacturers.
note
RAPath links to official Medsafe guidance — content is not reproduced here. Always access guidance directly from Medsafe to ensure you have the current version.
Medical device regulatory pages
| Resource | URL |
|---|---|
| Medical devices overview | medsafe.govt.nz — Devices |
| WAND database guidance | medsafe.govt.nz — WAND |
| Regulatory requirements for sponsors | medsafe.govt.nz — Sponsor requirements |
| Risk classification | medsafe.govt.nz — Classification |
| Exempt devices (Schedule 1) | medsafe.govt.nz — Exemptions |
| Adverse event reporting | medsafe.govt.nz — Adverse events |
| What's new | medsafe.govt.nz — What's new |
GHTF guidance documents adopted by Medsafe
The Global Harmonization Task Force produced a series of guidance documents that form the international baseline for Medsafe's regulatory expectations:
| GHTF document | Topic |
|---|---|
| GHTF/SG1/N43:2005 | Labelling for medical devices |
| GHTF/SG1/N011 | Summary Technical Documentation (STED) |
| GHTF/SG1/N015:2006 | Principles of Medical Devices Classification |
| GHTF/SG3/N15R8:2005 | Quality Management System — Process Validation |
| GHTF/SG5/N1R8:2007 | Clinical Evidence — Key Definitions |
| GHTF/SG5/N2R8:2007 | Clinical Evaluation |
GHTF documents are available via the IMDRF website at imdrf.org.
Categorisation service
If you are uncertain whether your product is a medical device, or how it would be classified, Medsafe offers an advisory categorisation service. Submit:
- Product description
- Labelling and instructions for use
- Promotional materials and intended use statement
Contact: devices@health.govt.nz