This episode provides a critical update on Mexico's new mandatory standard for medical device labeling, NOM-137-SSA1-2024. The host breaks down the key changes from the previous 2008 version, including the strict Spanish language requirement, new provisions for electronic labeling and Software as a Medical Device (SaMD), and updated rules for symbols and date formats. We cover the official publication and effective dates, helping manufacturers understand the timeline for compliance to maintain market access in Mexico.

- What is the new mandatory labeling standard for medical devices in Mexico?

- When does NOM-137-SSA1-2024 officially come into effect?

- Are English labels still acceptable in Mexico under the new regulation?

- How does the new standard address electronic labeling and Software as a Medical Device (SaMD)?

- What are the specific requirements for displaying expiration dates and using symbols?

- What happens if my device labeling is not compliant by the deadline?

- How does this 2024 update differ from the previous NOM-137-SSA1-2008?

Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies. We streamline global market access using a blend of local expertise and advanced AI. Whether you're navigating Mexico's new NOM-137 standard or expanding into any of our 30+ markets, our team can help with regulatory strategy, technical dossier submission, and post-market surveillance. Our technology-driven approach ensures efficiency and accuracy, helping you get to market faster. Explore our services at https://pureglobal.com, contact us at [email protected], or access our FREE AI tools and database at https://pureglobal.ai.