Useful links
Medsafe and Ministry of Health
| Resource | Link |
|---|---|
| Medsafe home | medsafe.govt.nz |
| Medsafe medical devices section | medsafe.govt.nz/regulatory/DevicesNew.asp |
| Medsafe What's New | medsafe.govt.nz/other/new.asp |
| Medsafe adverse event reporting | medsafe.govt.nz/safety/adverseevents.asp |
| Ministry of Health — medicines legislation | health.govt.nz/regulation-legislation/medicines-legislation |
| Medical Products Bill documents | health.govt.nz — Medical Products Bill |
| Device enquiries | devices@health.govt.nz |
Legislation
| Resource | Link |
|---|---|
| legislation.govt.nz (NZ legislation portal) | legislation.govt.nz |
| Medicines Act 1981 | legislation.govt.nz/act/public/1981/0118 |
| WAND Regulations 2003 | legislation.govt.nz/regulation/public/2003/0352 |
| Medicines Regulations 1984 | legislation.govt.nz |
International resources
| Resource | Link |
|---|---|
| GMDN Agency (GMDN codes) | gmdnagency.org |
| IMDRF (international guidance) | imdrf.org |
| GHTF documents (via IMDRF) | imdrf.org/documents/ghtf-documents |
| Australian TGA — medical devices | tga.gov.au/industry/medical-devices |
| Regulations.govt.nz (NZ consultations) | regulations.govt.nz |
Industry
| Resource | Link |
|---|---|
| Medical Technology Association of Australia (MTAA — covers NZ) | mtaa.org.nz |
| RAPS (Regulatory Affairs Professionals Society) | raps.org |
RAPath suite
| Jurisdiction | Link |
|---|---|
| Australia (TGA) | rapath.github.io/au/ |
| European Union (MDR/IVDR) | rapath.github.io/eu/ |
| Canada (Health Canada) | rapath.github.io/hc/ |
| Singapore (HSA) | rapath.github.io/sg/ |
| United Kingdom (MHRA) | rapath.github.io/uk/ |
| United States (FDA) | rapath.github.io/us/ |
| New Zealand (Medsafe) | rapath.github.io/nz/ |
| RAPath Hub | rapath.github.io/ |
Note: Some Medsafe URLs listed may redirect or have changed. Always verify the current URL by visiting medsafe.govt.nz and navigating to the relevant section. For device enquiries and adverse event reporting, devices@health.govt.nz is the current primary contact point.