Navigating NOM-241-SSA1-2021: Medical Device GMP Compliance in Mexico

Medical Device Global Market Access · Nov 19, 2025 · 3m

This episode provides a detailed overview of Mexico's mandatory Good Manufacturing Practices (GMP) standard, NOM-241-SSA1-2021. The host breaks down the key requirements for medical device manufacturers, including the implementation of a Quality Management System, risk management protocols, and alignment with ISO 13485. We discuss the standard's scope, its effective date, and the practical implications for companies seeking to enter or remain compliant in the Mexican market. Key Questions - What is NOM-241-SSA1-2021 and why is it critical for the Mexican market? - How does this standard…