Regulatory Framework Overview
Mexico's medical device regulatory system is built on three tiers of legislation and standards, all administered by COFEPRIS under the authority of the Ministry of Health (Secretaría de Salud / SSA).
The three tiers
Tier 1 — Ley General de Salud (General Health Law)
The Ley General de Salud is Mexico's primary federal health legislation. It:
- Establishes COFEPRIS as the federal authority for health risk protection.
- Creates the legal requirement for sanitary registration (registro sanitario) before placing medical devices on the market.
- Sets out the broad framework for GMP, advertising, import/export, and enforcement.
Tier 2 — Reglamento de Insumos para la Salud
The Health Supplies Regulation implements the Ley General de Salud. It provides:
- Definitions of medical devices and health supplies (insumos para la salud).
- Device classification criteria (Class I · II · III).
- Registration routes (standard and equivalency).
- Specific documentation requirements for each class.
- Import licence and distributor authorisation rules.
Tier 3 — Normas Oficiales Mexicanas (NOMs)
NOMs are mandatory technical standards. The key device NOMs are:
| NOM | Subject | Status |
|---|---|---|
| NOM-241-SSA1-2025 | Good Manufacturing Practices (GMP) | In force from April 2025 |
| NOM-137-SSA1-2008 | Labelling of medical devices | In force (draft update 2024) |
| NOM-240-SSA1-2012 | Technovigilance | In force (draft update 2024) |
COFEPRIS — the regulator
COFEPRIS was established in 2001 as a deconcentrated body within the Ministry of Health. Its mandate for medical devices includes:
- Pre-market: granting and denying sanitary registration.
- Quality systems: overseeing GMP compliance via inspections.
- Post-market: managing the national technovigilance system through the CNFV (Centro Nacional de Farmacovigilancia).
- Enforcement: conducting market surveillance, seizures, sanctions, and recalls.
COFEPRIS is a member of the IMDRF (International Medical Device Regulators Forum) and the PANDRH (Pan American Network for Drug Regulatory Harmonization), driving progressive alignment with international standards.
DIGIPRiS — the online platform
All submissions to COFEPRIS — registrations, renewals, modifications, import permits — are made through the DIGIPRiS online portal (Sistema Integral de Gestión de Permisos, Registros e Insumos para la Salud). See DIGIPRiS portal guide.
Recent reforms
COFEPRIS has undergone significant modernisation since 2024:
- The Equivalency Route now recognises all IMDRF and MDSAP member authorities (formalised June 2025).
- A new classification framework with three Annexes was published July 2025.
- NOM-241 was substantially updated in 2025.
- Renewal periods of up to 10 years were introduced in January 2026.