COFEPRIS Mexico Medical Device Regulations
COFEPRIS must approve your regulatory application before you can sell your medical device in Mexico.
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-SSA1-2025 (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 approvals from recognized regulatory authorities, such as FDA, EMA (EU CE Marking under MDD, IVDD, MDR, and IVDR), Health Canada, Swissmedic, ANVISA, TGA, MFDS, and NMPA, as well as other ICH, WHO, IMDRF, and MDSAP-recognized bodies.
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.
Regulatory UpdateMexico COFEPRIS Registration Guidance 2026Regulatory UpdateMexico NOM-137-SSA1-2025 Medical Device Labeling UpdateRegulatory UpdateCOFEPRIS 2026 Guidance on Electronic NotificationsRegulatory UpdateCOFEPRIS 2026 Modifications Guideline for Medical DevicesBlog ArticleHow to register medical devices and IVDs in MexicoBlog ArticleTurn FDA & EU Approvals Into Global Market AccessBlog ArticleMedical Device Registration Costs and Timelines for Brazil, Mexico, and ColombiaBlog ArticleMexico’s Abbreviated Regulatory Pathway is a Game-Changer for Medical Device Market AccessVideoUnderstanding Mexico's New Abbreviated PathwayVideoHow to Register a Medical Device with the US FDAFull COFEPRIS Support for a Simple Annual Fee
Pure Global replaces fragmented regulatory consulting fees with a single annual cost that covers registration, representation, and ongoing compliance. From faster, AI-enabled dossier preparation to post-market surveillance, everything required to keep your device compliant in Mexico is included. No hourly billing or unexpected invoices.
Frequently asked questions
Although an Affiliate Member to the Medical Device Single Audit Program (MDSAP), Mexico recognizes MDSAP Certificates as Good Manufacturing Practices (GMP) evidence. Manufacturers can leverage MDSAP Certification as a reference market when applying via the Abbreviated (or Equivalency) route . Therefore, if a foreign Manufacturer already holds an MDSAP certificate, it can use it in place of a Mexican GMP inspection report when applying for new device registrations.
Medical device registrations are initially valid for five years. Renewal application must be submitted at least 150 days before the registration expiration date. There are two types of renewals: first-time renewals , which require a more comprehensive documentation package (including GMP certification and a technovigilance report). second or subsequent renewals , which generally involve reduced documentation provided the device has remained compliant and unchanged. In January 2026, COFEPRIS introduced a reform that allows subsequent renewals to be granted for periods of up to ten years. All renewals are subject to government fees, assessed per product and based on risk class: MXN 12,374 (approximately USD 700) for Class I and Class I Low Risk, MXN 18,149 (approximately USD 1,027) for Class II, and MXN 23,098 (approximately USD 1,307) for Class III. Fees and renewal policies may change without notice. Check our Fee Calculator for up-to-date government fees in 14 markets.
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