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Terms of Use

Last Updated: December 9, 2025

IMPORTANT DISCLAIMER

Medevice.tech is an informational platform that aggregates, summarizes, and presents regulatory information from various medical device regulatory authorities worldwide. All content is generated using AI-assisted summarization and analysis tools. While we strive for accuracy, Medevice.tech should be used as a quick reference tool only. For official, legally binding information, always refer to the primary regulatory authority sources (FDA, EU Commission, MHRA, TGA, Health Canada, NMPA, etc.).

1. Nature of Service

Medevice.tech provides:

  • AI-generated summaries and analysis of medical device regulatory information
  • Curated updates from regulatory authorities including FDA, EU MDR/IVDR, MHRA, TGA, Health Canada, and NMPA
  • Educational guides and templates for regulatory professionals
  • Web scraping and aggregation of publicly available regulatory announcements
  • Links to primary source documents and official authority websites

2. AI-Generated Content Disclaimer

Medevice.tech content is generated through automated processes including:

  • AI-powered summarization using OpenAI GPT-4 and Anthropic Claude
  • Automated web scraping and content extraction
  • AI-generated explanatory articles and analysis

Users acknowledge that:

  • Information may contain errors, omissions, or inaccuracies
  • Summaries may omit important details present in original sources
  • AI-generated content may misinterpret regulatory nuances or technical requirements
  • Medevice.tech is NOT a substitute for official regulatory guidance
  • All regulatory decisions and compliance actions must be based on primary sources
  • Content may not reflect the most recent regulatory changes

3. Primary Source Authority

The only authoritative sources for medical device regulatory information are the official regulatory bodies:

  • FDA (U.S. Food and Drug Administration) - fda.gov
  • European Commission - ec.europa.eu (EU MDR/IVDR)
  • MHRA (UK Medicines and Healthcare products Regulatory Agency) - gov.uk/mhra
  • TGA (Australian Therapeutic Goods Administration) - tga.gov.au
  • Health Canada - canada.ca/health-canada
  • NMPA (China National Medical Products Administration) - nmpa.gov.cn

Users must verify all information with these primary sources before taking any regulatory or business actions.

4. No Professional Advice

Medevice.tech does not provide:

  • Legal advice or legal opinions
  • Regulatory consulting or compliance services
  • Quality management system guidance
  • Clinical or medical advice
  • Notified Body or certification services

For professional regulatory services, please consult qualified regulatory affairs professionals, legal counsel, or authorized regulatory consultants.

5. Limitation of Liability

Medevice.tech and its operators shall not be liable for:

  • Errors, omissions, or inaccuracies in AI-generated or summarized content
  • Delays in publishing regulatory updates
  • Business decisions made based on information from this site
  • Regulatory non-compliance resulting from reliance on this site
  • Product recalls, market withdrawals, or enforcement actions
  • Financial losses or damages arising from use of this service
  • Any direct, indirect, incidental, or consequential damages

6. Use of Templates and Guides

Templates and guides provided on Medevice.tech are for educational and reference purposes only. They are not guaranteed to meet specific regulatory requirements and should be reviewed and customized by qualified professionals before use in regulatory submissions. Users are responsible for ensuring compliance with applicable regulations.

7. Intellectual Property

Original content on Medevice.tech is owned by its operators. However, all regulatory information belongs to the respective regulatory authorities. Users may share and reference Medevice.tech content with attribution. Commercial use requires prior written permission.

8. Changes to Terms

We reserve the right to modify these terms at any time. Continued use of the site constitutes acceptance of updated terms. Users are encouraged to review these terms periodically.

9. Contact

For questions about these terms, please contact us through our website contact form.