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About RAPath

What is RAPath?​

RAPath is a free, independent, open-source reference covering medical device regulatory frameworks across multiple international jurisdictions. It is designed to help regulatory affairs professionals, manufacturers, importers, and anyone working in the medical device industry navigate the regulatory landscape more easily.

RAPath does not replace official sources — it helps you find them faster.

What RAPath covers​

RAPath provides plain-English summaries of publicly available regulatory information across the following 19 jurisdictions:

  • Australia — Therapeutic Goods Administration (TGA)
  • European Union — EU MDR / IVDR
  • United Kingdom — MHRA
  • United States — FDA
  • Canada — Health Canada
  • Singapore — Health Sciences Authority (HSA)
  • Japan — Pharmaceuticals and Medical Devices Agency (PMDA)
  • Switzerland — Swissmedic
  • China — National Medical Products Administration (NMPA)
  • India — Central Drugs Standard Control Organisation (CDSCO)
  • South Korea — Ministry of Food and Drug Safety (MFDS)
  • Brazil — ANVISA
  • Malaysia — Medical Device Authority (MDA)
  • Indonesia — BPOM / Kemenkes
  • Vietnam — Drug Administration of Vietnam (DAV) / Ministry of Health
  • Russia — Roszdravnadzor
  • Mexico — COFEPRIS
  • Saudi Arabia — Saudi Food and Drug Authority (SFDA)
  • New Zealand — Medsafe

Each jurisdiction site covers the regulatory framework from start to finish — classification, pre-market pathways, post-market obligations, legislation, and guidance.

How content is created​

All RAPath content is:

  • Sourced from publicly available information only — legislation, official guidance documents, and public regulatory publications. No internal, confidential, or non-public information from any regulatory authority is used or referenced.
  • Written with AI assistance — content is drafted using AI tools and reviewed for accuracy before publication.
  • Linked to authoritative sources — every page links directly to the official regulatory source so you can verify information independently.

RAPath is maintained on a voluntary basis by contributors in their own time, using their own equipment and resources.

What RAPath is not​

RAPath is not:

  • Legal advice or regulatory advice of any kind
  • Affiliated with, endorsed by, or connected to any regulatory authority or government body
  • A substitute for official regulatory guidance or qualified professional advice
  • A consulting service or commercial product

Always verify information against official sources before making any regulatory decision. If you are preparing a regulatory submission or advising a client, seek qualified professional advice.

See the Terms of Use & Disclaimer for the full legal terms.

Independence and governance​

RAPath is an independent open-source project, created and maintained outside of any professional role or employment responsibilities.

Content is developed without reference to any internal, unpublished, or non-public regulatory material. RAPath does not engage with, advise, or represent sponsors, manufacturers, importers, distributors, or any other entity regulated by a medical device authority.

Where a potential conflict of interest is identified, content may be reviewed, modified, or restricted to maintain impartiality.

Contributing​

RAPath is open source and welcomes contributions. If you spot an error, an outdated reference, or a gap in coverage, you can:

  • Open an issue or discussion on GitHub
  • Submit a pull request with a correction or addition

All contributions are reviewed before publication. Contributors are expected to source content from publicly available regulatory information only.

Questions or concerns​

If you have a question about RAPath, spot an error, or have a concern about any content, please use GitHub Discussions.

RAPath exists to make medical device regulation more accessible. It is built on the belief that clearer navigation of public regulatory information helps everyone — manufacturers, regulators, patients, and the public.