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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…
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