Overview
Companies looking to commercialize medical devices internationally often target two major markets: the United States and Mexico. These countries are regulated by two robust authorities — the FDA (Food and Drug Administration) in the U.S. and COFEPRIS (Federal Commission for Protection against Sanitary Risks) in Mexico — each with distinct regulatory frameworks.
Understanding the differences between FDA and COFEPRIS approval processes is essential for planning efficient market entry, minimizing risks, and reducing time-to-market. In this blog post, we provide a clear comparison of both regulatory systems, including requirements, timelines, and strategic advantages.
Introduction
The medical device industry is growing rapidly, driven by innovation and population aging. For manufacturers, entering the U.S. and Mexican markets offers valuable opportunities — provided the regulatory requirements are properly met.
While both countries emphasize safety, efficacy, and quality, the pathways to market authorization differ. The FDA is considered a global regulatory gold standard, while COFEPRIS has been modernizing and establishing itself as a key authority in Latin America.
Documentation Requirements
FDA:
- Electronic submissions via eSTAR (for 510(k))
- Clinical studies (when applicable)
- Technical files, validation reports
- Quality system documentation (ISO 13485 is optional but recommended)
COFEPRIS:
- Spanish-language technical dossier
- International certificates (FDA, CE Mark, Health Canada, etc.)
- Labeling, instructions for use (IFU) in Spanish
- Certified translations and local review
Pro Tip: COFEPRIS accepts foreign approvals to streamline the process. The FDA typically requires substantial equivalence demonstrated through U.S.-based testing.
Advantages and Challenges
FDA (USA):
- ✅ Global recognition
- ✅ Access to the world’s largest healthcare market
- ❌ Complex and costly process
- ❌ High technical burden
Cofepris (Mexico):
- ✅ More accessible and affordable
- ✅ Strategic entry to Latin America
- ✅ Accepts international certifications
- ❌ Less predictable review timelines
❌ Ongoing digital modernization
Conclusion
For companies seeking international expansion, understanding the differences between FDA and COFEPRIS regulatory pathways is more than a compliance task — it’s a business strategy. While FDA approval provides global credibility, COFEPRIS offers a faster and more flexible entry into Latin America.
Evaluate your product’s risk level, target market, and existing certifications. In many cases, leveraging previous approvals can ease your path in Mexico. Also, partnering with local consultants or authorized third parties can significantly simplify your regulatory journey.
GRP can act as your local Agent & Register your product in U.S
Contact our team today to Inquire!
Email: info@globalregulatorypartners.com
Telephone : (+1) 781-672-4200
References
Learn more about Mexico. For the link, click here
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and South Korea. GRP helps many life science companies register their products in different countries in compliance with local regulations.