🇲🇽Mexico Medical Device Regulations

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.

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.

Medical Device Technovigilance

Current technovigilance standard establishing the National Technovigilance System structure and adverse event reporting requirements. CNFV oversees compliance.

Good Manufacturing Practice for Medical Devices

GMP requirements for medical device establishments including quality systems, design controls, production, and distribution.

Labeling Requirements for Medical Devices

Labeling requirements for medical devices including Spanish language, registration number, manufacturer details, and storage conditions.

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.