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/ |