Chapter 1 Mexican COFEPRIS Administration Information Abstract

1. Administration and Abstract

The regulatory authority for medical devices in Mexico is the Commisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), The agency is under the jurisdiction of the Mexican Ministry of Health (Secretaría de Salud). COFEPRIS is responsible for medical device market access, market surveillance and inspection, regulatory development and update, adverse event monitoring and reporting.

2. Administrative Regulation

Ley General de Salud

3. Risk Level Classification

Classification of medical devices in Mexico follows international standards, and according to the provisions of the Mexican Ministry of Health, medical devices are classified into Class I, Class II, and Class III:

4. Entry Requirements

①ISO 13485

②Certificate of Free Sale (CFS) or Certificate to Foreign Government (CFG).

③ Instructions for Use (IFU)

④ Label

⑤ Technical documents

⑥ Test report

5. Registration Language

Spanish.

Chapter 2 Registration Flow、Cycle & Official Fee

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 Commisión 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.