Mexico
Mexico is the second-largest medical device market in Latin America, with strong demand for innovative technologies and imported products.
Do you require help or further information?
Contact us! We are happy to advise you:
Regulatory Framework
The regulatory authority is the Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS).
Device Classification:
- Class I: Low risk
- Class II: Moderate risk
- Class III: High risk
Specific Local Requirements
| Language | Documentation in Spanish. |
| Local Representative | Mandatory for foreign companies. |
| Certifications | ISO 13485 certificate and compliance with COFEPRIS regulations. |
Challenges and Operational Advice
- Potential delays: The process may be slowed down by bureaucratic controls.
- Translations: High-quality translations into Spanish are essential.
Why Choose ISEMED
- Specific Expertise
In-depth knowledge of COFEPRIS procedures. - Complete Support
Assistance from preliminary analysis to final authorization.
FAQ
- Is a local representative required? Yes.
- Documentation language? Spanish.
- License duration? 5 years.