This episode provides a comprehensive overview of Mexico's foundational health regulation, the Ley General de Salud, and its impact on medical device market access. We explore the role and authority of the regulatory body, COFEPRIS, and break down the key requirements manufacturers must meet, from pre-market registration and GMP compliance to post-market technovigilance and import controls.

Key Questions

- What is the Ley General de Salud and why is it critical for MedTech companies?

- How does COFEPRIS regulate medical devices in Mexico?

- What are the essential components of Mexico's regulatory framework for medical devices?

- Are foreign manufacturers required to have a local representative in Mexico?

- What are Norma Oficial Mexicana (NOMs) and how do they apply to manufacturing?

- What is "technovigilance" and what are the post-market requirements?

- Does Mexico have a risk-based classification system for medical devices?

Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, streamlining global market access with a unique blend of local expertise and advanced AI tools. Our Market Access & Registration services help you identify the best markets, develop efficient regulatory strategies, and prepare technical dossiers for submission. Acting as your local representative in over 30 markets, we manage the entire registration process to get your product approved and ready for sale. Visit https://pureglobal.com/, email us at [email protected], or explore our FREE AI tools and database at https://pureglobal.ai to learn more.