Medical Device Regulatory Reference — Plain English. Properly sourced.
RAPath is an open, community-maintained reference for medical device regulation across 16+ jurisdictions. Every page is written in plain English, links back to the authoritative legislative or regulatory source, and is openly available to anyone who needs it.
| Jurisdiction | Regulator | Status | URL |
|---|---|---|---|
| 🇦🇺 Australia | TGA | Live | rapath.github.io/au |
| 🇪🇺 European Union | MDR & IVDR | Live | rapath.github.io/eu |
| 🇨🇦 Canada | Health Canada | Live | rapath.github.io/hc |
| 🇸🇬 Singapore | HSA | Live | rapath.github.io/sg |
| 🇬🇧 United Kingdom | MHRA | Live | rapath.github.io/uk |
| 🇺🇸 United States | FDA | Live | rapath.github.io/us |
| 🇯🇵 Japan | PMDA | Live | rapath.github.io/jp |
| 🇨🇭 Switzerland | Swissmedic | Live | rapath.github.io/swiss |
| 🇨🇳 China | NMPA | Live | rapath.github.io/cn |
| 🇮🇳 India | CDSCO | Live | rapath.github.io/in |
| 🇰🇷 South Korea | MFDS | Live | rapath.github.io/kr |
| 🇧🇷 Brazil | ANVISA | Lives | rapath.github.io/br |
| 🇲🇾 Malaysia | MDA | Live | rapath.github.io/my |
| 🇮🇩 Indonesia | BPOM | Live | rapath.github.io/id |
| 🇻🇳 Vietnam | DAV / MOH | Live | rapath.github.io/vt |
| 🇷🇺 Russia | Roszdravnadzor | In progress | rapath.github.io/ru |
Regulatory frameworks for medical devices are accurate but difficult to navigate. Legislation is authoritative but hard to read. Official guidance is comprehensive but scattered across multiple sources.
RAPath sits between official sources and the reader — structured, searchable, and plain English — with every page linked back to the authoritative legislative or regulatory source. It is not a replacement for official regulatory sources. It is a navigation aid.
RAPath is for:
- Regulatory affairs professionals and consultants
- Sponsors and manufacturers entering new markets
- Importers and distributors
- Anyone new to medical device regulation in any of the covered jurisdictions
RAPath is a community reference. Regulatory affairs professionals who flag errors, suggest improvements, or contribute content make this resource better for everyone.
⚠️ Content across all RAPath sites is written with AI assistance and is intended as a navigation aid only. Always verify against official regulatory sources before making any regulatory decisions. RAPath is not affiliated with any regulatory authority. Nothing on this site constitutes legal or regulatory advice.
- Docusaurus v3 — documentation framework
- GitHub Pages — hosting
- Algolia DocSearch — search
- Content written with AI assistance (Claude by Anthropic)
Last updated: May 2026