COFEPRIS Mexico Medical Device Regulations

Key medical device and IVD regulations in Mexico

The Comisión Federal para la Protección contra Riesgos Sanitarios, known as COFEPRIS, is the division within the Mexican Secretariat of Health that regulates medical devices in Mexico. COFEPRIS medical device regulations cover advertising, manufacturing, and importation of health-related products and industries, including drugs, food, medical devices, organ transplants, and even environmental protections. Confirm whether sanitary registration or an applicable exemption applies before import/supply, and separately assess establishment, import and labeling requirements.

COFEPRIS enforces requirements in two primary health regulations:

General Health Law (Ley General de Salud) outlines the regulatory framework for medical devices and pharmaceuticals.

Regulations of Health Supplies (Reglamento de Insumos para la Salud) addresses specific regulatory requirements for medical devices.

COFEPRIS also develops its own standards and regulations, called NOMs, which is abbreviated from Norma Oficial Mexicana. NOMs exist for a range of activities concerning medical devices, such as NOM-241-SSA1-2025 (link in Spanish), which addresses COFEPRIS requirements for Good Manufacturing Practices (GMP).

COFEPRIS Mexico medical device regulatory process

There are two registration routes: the Standard Route (country of origin certification) and the Equivalency (or Abbreviated) Route, which leverages your existing device registration from a recognized authority.

Standard Route

This route involves submitting a complete registration dossier to COFEPRIS. The dossier must include comprehensive technical documentation, clinical evidence, labeling information, and other required documents. COFEPRIS conducts a thorough review of the submitted dossier, which can take a considerable amount of time due to the complexity and volume of submissions.

Equivalency Route (Abbreviated Pathway)

Effective September 1, 2025, COFEPRIS has expanded eligibility criteria and shortened review timelines for the Equivalency Route, also known as the Abbreviated Regulatory Pathway. This route allows manufacturers to obtain expedited marketing authorization in Mexico based on prior authorization from a regulator of a country on the IMDRF Management Committee — covering FDA, EU CE marking, Health Canada, Swissmedic, ANVISA, TGA, MFDS, and NMPA — with full MDSAP members additionally recognized for GMP certification. (The ICH- and WHO-listed authorities in the Lineamientos apply to medicines, not devices.)

To qualify, the medical device submitted must be identical to the version approved by the reference authority. This includes formulation, manufacturing process, intended use, and technical specifications. Submission requirements include: Certificate of Free Sale (CFS) and conformity assessment from your reference authority, Clinical Evaluation Report (CER), risk analysis, draft labeling in Spanish, and more. The route specifies a 30-working-day decision framework, subject to the applicable complete-application and procedural conditions; this is not a guaranteed total launch time.

Apply each legal layer to the right question

Use the official COFEPRIS procedure directory and issued authorization terms. Foreign approval, a CE mark or a quality certificate has a specific evidentiary role and should not be presented as a universal waiver of the Mexican requirements. See classification, labeling and postmarket maintenance.