Mexico's New Medical Device Labeling Standard: COFEPRIS NOM-137-SSA1-2025 Compliance by 2027

In this episode, we break down Mexico's new comprehensive medical device labeling standard, NOM-137-SSA1-2025, published by the health regulator COFEPRIS. We explore the key changes from the previous 2008 version, including new definitions for 'component' and 'single-use device,' and the new mandate to include the intended use, manufacturing date, and catalog number directly on device labeling. We also discuss the critical compliance deadline of May 14, 2027, and outline practical steps that manufacturers must take during the one-year transition period to update their labels and Instructions for Use (IFU) to maintain market access in Mexico. Key Questions: - What are the most significant changes in Mexico's new medical device labeling standard, NOM-137-SSA1-2025? - How do the new definitions for 'component' and 'single-use device' affect our products? - What specific new information must be added to our device labels to comply with COFEPRIS? - What is the final deadline for all devices on the Mexican market to meet these new requirements? - How should we manage existing inventory with legacy labeling during the transition period? - What are the potential consequences of non-compliance after May 14, 2027? - What are the first steps our regulatory team should take to create a transition plan? - Does the new standard impact the requirements for Instructions for Use (IFU) as well? Sources: - https://www.emergobyul.com/news/mexicos-cofepris-publishes-final-version-medical-device-labeling-standard - https://www.pure-global.com/news-and-updates/medical-device-regulatory-news-and-updates How Pure Global can help: Pure Global helps MedTech and IVD companies access global markets faster. Our experts in Mexico can manage your transition to the new NOM-137-SSA1-2025 labeling standard, acting as your local representative and ensuring your technical dossiers are fully compliant. We use advanced AI to streamline document compilation and submission, reducing delays and costs. Whether you're a startup or a multinational, our end-to-end solutions cover regulatory strategy, quality assurance, and post-market surveillance to maintain your market presence. Contact us at [email protected], visit https://pureglobal.com, or explore our free AI tools and regulatory database at https://pureglobal.ai.