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. Before you can import and sell your medical device or IVD in Mexico, COFEPRIS must review and approve your regulatory application.
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-SSA1-2021, which addresses COFEPRIS requirements for Good Manufacturing Practices (GMP).
COFEPRIS Mexico medical device regulatory process
There are two registration paths: the standard path (country of origin certification) and the equivalent path (reference countries are the US, Canada, and Japan).
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 approvals from recognized regulatory authorities that are members of the IMDRF or MDSAP.
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. COFEPRIS is required to issue a decision within 30 business days of receiving a complete application.
