Decoding NOM-241: Mexico's New GMP Framework for Medical Devices

Medical Device Global Market Access · Aug 22, 2025 · 3m

This episode unpacks the crucial updates in Mexico's NOM-241-SSA1-2021, the mandatory standard for Good Manufacturing Practices for medical devices. We explore the enhanced Quality Management System (QMS) requirements, the formal inclusion of Software as a Medical Device (SaMD), and the significant decision by COFEPRIS to accept ISO 13485 and MDSAP certifications from foreign manufacturers, streamlining market access. Key Questions: • What is NOM-241-SSA1-2021 and when did it become mandatory for medical device manufacturers? • How does the new standard change the definition of a medical…