Mexico medical device regulations
Official sources linkedCOFEPRIS rules and guidance for medical device market access, registration, and lifecycle compliance. Each code opens a metadata page with the official source and readable HTML when available.
| Code | Regulation | Category | Effective | Provenance |
|---|---|---|---|---|
| NOM-137-SSA1-2025 | Labeling Requirements for Medical Devices (2025) Updated labeling standard for medical devices. Replaces NOM-137-SSA1-2008 when it takes effect 360 days after DOF publication. Allows 180 additional days to exhaust existing packaging. | Labeling | May 14, 2027 | Official |
| NOM-241-SSA1-2025 | Good Manufacturing Practices for Medical Devices (2025) Updated GMP standard for medical devices. Removes classification chapter (now in Mexican Pharmacopoeia Supplement 5.0). Aligns with ISO 13485:2016. Replaces NOM-241-SSA1-2021. | GMP/QMS | November 30, 2025 | Official |
| NOM-241-SSA1-2021 | Good Manufacturing Practices for Medical Devices (2021) GMP requirements for medical device design, development, manufacturing, storage, and distribution. Replaced NOM-241-SSA1-2012. Will be obsolete November 30, 2025. | GMP/QMS | June 20, 2023 | Official |
| NOM-240-SSA1-2012 | Medical Device Technovigilance Current technovigilance standard establishing the National Technovigilance System structure and adverse event reporting requirements. CNFV oversees compliance. | Vigilance | December 30, 2013 | Official |
| NOM-241-SSA1-2012 | Good Manufacturing Practice for Medical Devices GMP requirements for medical device establishments including quality systems, design controls, production, and distribution. | GMP/QMS | October 11, 2012 | Official |
| NOM-137-SSA1-2008 | Labeling Requirements for Medical Devices Current labeling standard for medical devices, including Spanish-language information, registration number, manufacturer details, and storage conditions. Remains in force until NOM-137-SSA1-2025 takes effect on May 14, 2027. | Labeling | November 12, 2008 | Official |
| NOM-064-SSA1-1993 | Sanitary Specifications for In Vitro Diagnostic Reagents Establishes minimum sanitary specifications for diagnostic reagent supplies used as diagnostic agents in measurements of human tissue, fluid, and secretion samples (IVDs). Still mandatory for IVD evaluation. | General | 1995 | Official |
Exports carry source + retrieval dateWhat these codes are
Each row above represents one regulatory instrument. Its code is the authority’s identifier. A regulation page collects the metadata and official source; when readable HTML is available, article links can open and highlight the exact cited passage.
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