The regulatory authority for medical devices in Mexico
The regulatory body for medical devices in Mexico is the Federal Commission for the Protection against Sanitary Risks (COFEPRIS), which is under the jurisdiction of the Mexican Ministry of Health (Secretaría de Salud). COFEPRIS is responsible for the market access of medical devices, market supervision and inspection, regulation formulation and updates, as well as monitoring and reporting of adverse events.
Regulatory Authority's official website link:https://www.gob.mx/cofepris
Database link: https://www.gob.mx/cofepris/documentos/registros-dispositivos-medicos
Regulatory regulations
Ley General de Salud
Risk level classification
Mexico follows international standards for medical device classification, as defined by the Mexican Ministry of Health, dividing devices into three risk-based classes:
Holder's Requirements
It must be a local legal entity in Mexico; a certified compliance officer must be appointed.
Essential conditions for entry.
①ISO 13485
② Free Sale Certificate (CFS) or Letter to Foreign Government (CFG).
③ User Manual (IFU)
④ Label
⑤ Technical documents
⑥ Test Report
Registration language
Registration process, duration and official fees
1. Registration Flow
2. Cycle & Official Fee
Chapter 3 FAQ
Q: Do all application documents for registration in Mexico have to be in Spanish?
A: When registering in Mexico, the product labels and instructions must be in Spanish. Label content should include product name, model, instructions for use, warning information, expiration date (if applicable), manufacturer information, etc.
Q: Can the Mexican registration certificate be changed?
A: If the design, manufacturing process and intended use of medical devices are changed, it is necessary to evaluate the impact of the change on product safety and effectiveness in a timely manner, and submit a change application to the Mexican health regulatory authority, and the change can be implemented after approval.
Q: How long is the Mexican registration certificate valid?
A: Five years.
Q: Can a Mexican certificate be renewed?
A: Sure. Prior to the expiration of the registration certificate, the manufacturer is required to submit a renewal application to the Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS). Renewal applications usually need to be initiated six months prior to the expiration date to ensure timely acquisition of a new registration certificate.
