Medical Device Regulatory Reference — Plain English. Properly sourced.
RAPath is an independent open-source reference for medical device regulation across 19 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 |
| 🇳🇿 New Zealand | Medsafe | Live | rapath.github.io/nz |
| 🇪🇺 European Union | MDR & IVDR | Live | rapath.github.io/eu |
| 🇬🇧 United Kingdom | MHRA | Live | rapath.github.io/uk |
| 🇨🇭 Switzerland | Swissmedic | Live | rapath.github.io/swiss |
| 🇨🇦 Canada | Health Canada | Live | rapath.github.io/hc |
| 🇺🇸 United States | FDA | Live | rapath.github.io/us |
| 🇲🇽 Mexico | COFEPRIS | Live | rapath.github.io/mx |
| 🇧🇷 Brazil | ANVISA | Live | rapath.github.io/br |
| 🇯🇵 Japan | PMDA | Live | rapath.github.io/jp |
| 🇨🇳 China | NMPA | Live | rapath.github.io/cn |
| 🇰🇷 South Korea | MFDS | Live | rapath.github.io/kr |
| 🇮🇳 India | CDSCO | Live | rapath.github.io/in |
| 🇸🇬 Singapore | HSA | Live | rapath.github.io/sg |
| 🇲🇾 Malaysia | MDA | Live | rapath.github.io/my |
| 🇮🇩 Indonesia | BPOM | Live | rapath.github.io/id |
| 🇻🇳 Vietnam | DAV / MOH | Live | rapath.github.io/vt |
| 🇷🇺 Russia | Roszdravnadzor | Live | rapath.github.io/ru |
| 🇸🇦 Saudi Arabia | SFDA | Live | rapath.github.io/sa |
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 includes 19 free, interactive tools — no account required.
| Category | Tools |
|---|---|
| Classification | Device Classification Wizard, IVD Classification Track, SaMD Decision Tree |
| Planning | Regulatory Timeline Planner, Regulatory Fee Estimator |
| Analysis | Jurisdiction Comparison Tables, MDSAP Value Map, Regulatory Gap Analysis |
| Manufacturers | GSPR / Essential Req. Mapper, Clinical Evidence Calculator, Labelling Requirements Checker, Post-Market Obligations Calendar |
| Importers & Distributors | Import Requirements Checker, Distributor Obligations Guide, Submission Readiness Checklist |
| RA Consultants | Acronym & Glossary Lookup, Economic Operator Map, Regulatory Process Flow |
| Software / SaMD | Cybersecurity Requirements |
RAPath is a community reference. Regulatory affairs professionals who flag errors, suggest improvements, or contribute content make this resource better for everyone.
⚠️ Independent open-source project. All content is derived from publicly available sources only — legislation, official guidance documents, and public regulatory publications. No internal, confidential, or non-public information from any regulatory authority is used or referenced.Content across all RAPath sites is written with AI assistance and is intended as a navigation aid only — not legal or regulatory advice, and not affiliated with any regulatory authority. Always verify against official regulatory sources before making any regulatory decision.
- Docusaurus v3 — documentation framework
- GitHub Pages — hosting
- Content written with AI assistance (Claude by Anthropic)
Last updated: May 2026