Overview
How to register medical devices with Cofepris in Mexico. This Blog explains risk classification, documentation, timelines, and tips for national and international companies.
Introduction
Looking to market a medical device in Mexico in 2025? Then understanding the sanitary registration process with Cofepris (Mexico’s Federal Commission for Protection against Health Risks) is essential. The regulatory framework is strict but increasingly aligned with international standards, making the country a strategic entry point into Latin America.
In this Blog, you’ll learn how the medical device registration process works in Mexico, from risk classification to required documents, timelines, and the fastest pathways to approval.
How the Medical Device Registration Process Works in Mexico
Risk Classification
The first step is to determine the risk class of your product:
- Class I: Low risk (e.g., basic bandages, gauze)
- Class II: Medium risk (e.g., catheters, surgical instruments)
- Class III: High risk (e.g., implants, cardiac valves)
Risk class determines the complexity of the dossier and the regulatory path.
Required Documentation
A complete technical dossier should include:
- Detailed technical description
- International certifications (e.g., CE Mark, FDA approval, ISO 13485)
- Manufacturer details and quality control documentation
- User manual and labeling in Spanish
- Clinical studies (required for Class II and III, when applicable)
Translations must be officially certified if documents are not in Spanish.
Registration Pathways
There are two main submission options:
- Directly with Cofepris: traditional pathway, physical or electronic.
- Through an Authorized Third Party (Tercer Autorizado): certified private entities that provide technical evaluations to speed up the process.
Your choice depends on urgency, budget, and your company’s familiarity with the regulatory process.
Timelines and Validity
- Standard review time: 3 to 8 months
- With Authorized Third Party: as fast as 1 to 3 months
- Validity of registration: 5 years, renewable if no substantial changes occur
Recognition of Foreign Registrations
Cofepris allows a simplified pathway for products already registered in countries like the USA, Canada, Japan, or EU members. International certificates can support the process under regulatory harmonization efforts.
Conclusion
The registration of medical devices with Cofepris is detailed and highly regulated, but also increasingly transparent and internationally harmonized. Preparing a solid dossier, choosing the best submission strategy, and staying compliant with documentation requirements are key to successfully entering the Mexican market.
For companies operating in health product regulation, or planning to expand into Mexico in 2025, understanding the Cofepris process is a vital strategic move.
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.