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Terms of Use & Disclaimer

Last updated: May 2026

Please read these terms carefully before using any RAPath site. By accessing or using any page on the RAPath network (rapath.github.io and its subpaths), you agree to the terms set out below.

1. About RAPath​

RAPath is a free, open, community-maintained reference covering medical device regulatory frameworks across multiple jurisdictions. It is hosted on GitHub Pages and published under the RAPath organisation on GitHub.

RAPath is operated by contributors on a voluntary basis. It is not a company, legal entity, regulatory body, or commercial service.

Nothing on any RAPath site constitutes legal advice, regulatory advice, or professional advice of any kind.

The content on RAPath is written for general informational and educational purposes only. It is intended to help readers navigate and understand regulatory frameworks — it is not a substitute for:

  • Advice from a qualified regulatory affairs professional
  • Advice from a licensed legal practitioner
  • Official guidance from a regulatory authority
  • The authoritative text of applicable legislation, regulations, or standards

If you are making a regulatory submission, preparing technical documentation, advising a client, or taking any action that has legal or regulatory consequences, you must verify all relevant requirements against official sources and, where appropriate, seek qualified professional advice.

3. AI-Assisted Content​

Content across all RAPath sites is written with the assistance of AI tools (including Claude by Anthropic). While every effort is made to ensure accuracy, AI-generated content can contain errors, omissions, or outdated information.

AI-generated content is not a reliable substitute for official regulatory sources. Always verify information against the primary source before relying on it.

4. Accuracy, Currency, and Completeness​

Medical device regulation changes frequently. New legislation is enacted, guidance documents are updated, transitional provisions expire, and regulatory interpretations evolve. RAPath makes reasonable efforts to keep content current, but:

  • Pages may not reflect the most recent regulatory changes
  • Information may be incomplete or may not apply to your specific situation
  • Coverage varies by jurisdiction — not all regulatory requirements are covered for every country
  • Translations or plain-English summaries of legal text may not capture every nuance of the original

Always verify information against official sources before making any regulatory decision.

5. No Affiliation with Regulatory Authorities​

RAPath is an independent reference. It is not affiliated with, endorsed by, or connected to any regulatory authority, government body, or official institution, including but not limited to:

  • Therapeutic Goods Administration (TGA), Australia
  • European Commission / DG SANTE / EUDAMED
  • Health Canada
  • Health Sciences Authority (HSA), Singapore
  • Medicines and Healthcare products Regulatory Agency (MHRA), UK
  • U.S. Food and Drug Administration (FDA)
  • Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • Swissmedic, Switzerland
  • National Medical Products Administration (NMPA), China
  • Central Drugs Standard Control Organisation (CDSCO), India
  • Ministry of Food and Drug Safety (MFDS), South Korea
  • ANVISA, Brazil
  • Any other national or regional regulatory authority

References to these organisations and links to their websites are provided solely to help readers locate authoritative sources. RAPath has no formal relationship with any of them.

6. Limitation of Liability​

To the fullest extent permitted by applicable law, RAPath, its contributors, maintainers, and affiliated individuals:

  • Accept no liability for any loss, damage, cost, expense, or consequence arising from your use of, or reliance on, any content on any RAPath site
  • Accept no liability for regulatory submissions, decisions, or actions taken based on information found on RAPath
  • Accept no liability for any inaccuracy, error, omission, or outdated information on any RAPath page
  • Accept no liability for any interruption, unavailability, or change to the RAPath sites

This limitation applies whether liability arises in contract, tort (including negligence), statute, or otherwise.

If you are dissatisfied with any content on RAPath, your sole remedy is to stop using the site.

RAPath links extensively to external websites, including regulatory authority websites, legislation databases, and official guidance portals. These links are provided as a convenience and for informational purposes only.

RAPath has no control over the content, availability, or accuracy of external websites. Linking to an external site does not constitute endorsement of that site or its content. External sites have their own terms of use and privacy policies, which you should review independently.

8. Open Source and Intellectual Property​

RAPath's source code is published on GitHub and is available under open source terms. Regulatory text, legislation, and official guidance documents referenced or quoted on RAPath remain the intellectual property of their respective owners and are referenced for informational purposes under applicable fair use or open government licence terms.

Content authored by RAPath contributors (summaries, explanations, navigation text) is made available under open terms consistent with the project's GitHub repository licence. Where AI assistance has been used to generate content, contributors have reviewed and take responsibility for that content.

9. Privacy​

RAPath does not collect personal data directly. The site is hosted on GitHub Pages, which may collect server logs in accordance with GitHub's Privacy Statement. Search functionality is provided by Algolia DocSearch, which operates under Algolia's Privacy Policy.

RAPath does not use cookies for tracking, advertising, or analytics.

10. Changes to These Terms​

These terms may be updated from time to time. The date at the top of this page reflects the most recent revision. Continued use of RAPath following any update constitutes acceptance of the revised terms.

11. Questions​

If you have questions about these terms, spot an error, or have a concern about any content on RAPath, please use GitHub Discussions.

RAPath is a community reference. It exists to make medical device regulation more accessible. These terms exist to be honest about what it is and what it is not.