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Reglamento de Insumos para la Salud

The Reglamento de Insumos para la Salud (RIS) is the principal secondary legislation governing medical devices in Mexico. It implements the Ley General de Salud at an operational level, providing the detailed rules for classification, registration, GMP, labelling, import, and post-market obligations.

Status and authority​

  • Issued by the Executive Branch (Poder Ejecutivo Federal) under the authority of the Ley General de Salud.
  • Published in the Diario Oficial de la Federación (DOF) and periodically amended.
  • Binding on all parties — manufacturers, importers, distributors, MRHs, and healthcare facilities.

Structure and key provisions​

Definition of health supplies and medical devices​

The RIS defines the categories of insumos para la salud (health supplies), which include:

  • Medical devices (equipo médico, prótesis, órtesis, ayudas funcionales)
  • Diagnostic agents (agentes de diagnóstico — IVDs)
  • Dental products (materiales dentales)
  • Surgical and healing materials

Device classification​

The RIS establishes the three-class risk system (Class I · II · III) and delegates the detailed classification rules to the Mexican Pharmacopoeia and COFEPRIS decrees (including the July 2025 Annex decree).

Registration requirements​

The RIS specifies:

  • Which health supplies require sanitary registration (registro sanitario).
  • Which may be sold under a simplified notification or exemption.
  • Dossier requirements for each class of device.
  • The two registration routes (standard and equivalency).

MRH requirements​

The RIS establishes the requirement for a Mexico Registration Holder for foreign manufacturers and defines the MRH's responsibilities.

GMP obligations​

The RIS requires compliance with applicable NOMs (principally NOM-241) for manufacturers, importers, and distributors.

Labelling​

The RIS establishes that medical devices must comply with labelling requirements per the applicable NOM (NOM-137-SSA1-2008).

Technovigilance​

The RIS creates the framework for Mexico's technovigilance system, implemented in detail through NOM-240-SSA1-2012.

Import and export​

The RIS governs import permits, export authorisations, and the Aviso de funcionamiento requirements for import/distribution facilities.

Sanctions​

The RIS specifies the types of non-compliance subject to sanctions under the Ley General de Salud enforcement provisions.

How to access the Reglamento​

The current consolidated text is available through the Cámara de Diputados website (www.diputados.gob.mx) and the DOF. Verify the version is the most current, as amendments are made periodically.