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

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 device in Mexico? • What are the core components of the newly emphasized Quality Management System? • Does COFEPRIS now officially recognize ISO 13485 and MDSAP for GMP compliance? • What does the update mean for software as a medical device (SaMD) manufacturers? • How can foreign manufacturers streamline their path to compliance in Mexico? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.