I. COFEPRIS Introduction

COFEPRIS: The regulatory body that oversees medical devices in Mexico is the Federal Commission for the Defense of Health Risks (Comisión Federal de Defensa de los Risos Sanitarios), under the jurisdiction of the Mexican Ministry of Health. Regulates medical devices and in vitro diagnostic devices (IVD). In addition to medical devices, COFEPRIS oversees pharmaceutical regulation, food safety and environmental protection.

II. Applicable Regulation

1. Basic framework: Mexico's General Health Law (Ley General de Salud)

2. Good manufacturing practice for medical devices: NOM-241-SSA1-2012.

3. Medical device product labeling regulations: NOM-137-SSA1-2008.

4. Technical vigilance program: lNOM-240.

III. Medical Devices Classification

Medical devices in Mexico are categorized as, low risk, Class I, Class II, and Class III, with low risk devices not requiring registration.

IV. Medical Device Registration Information

1. Free sale certificate FSC or CFG

2. ISO13485 quality system certificate

3. Authorization (fixed format, dual certification required)

4. Clinical evaluation reports or clinical trial reports

5. IFU and labeling

6. Security test reports

7. Other technical documents and some system documents.

The above documents are required to be available in Spanish

The registration period will vary depending on the category, probably between 4-10 months. The registration certificate is valid for 5 years.

V. System assessment

1. Class I low-risk medical device documentation requirements:

Power of attorney

Labeling of products

IFU

Agent agreement

Distribution letter from each distributor

Free sale certificate (manufacturer can sell products in China and export them abroad)

Authorization of the Ministry of Health in China.

2. There are three routes to product certification for Class I, II and III products:

(1) Criteria: Full set of technical documents that must be submitted and receive full-cycle audits compared to equivalent routes.

(2) Equivalent protocol pathway: This applies to all medical devices approved in the United States. Or, if it has been approved in Canada or Japan, but is not Class I in those countries. If it's Class I, then you have to choose the standard or standard + third party route. Fewer technical documents must be submitted than in the standard process, and the review time will be significantly reduced.

(3) Standard + 3rd party routes: this only applies to new registrations or any other modifications and newer (does not applicable to equivalent routes). This option cannot be used if the process has been previously started via an equivalent protocol route. COFEPRIS recognizes the use of third-party review (TPR). TPR is often a commercial private organization authorized by COFEPRIS to initially review applications. If all sections meet their criteria, they will write a formal technical report for COFEPRIS recommending approval. Usually, after TPR submits their report, no additional information is required to be submitted to COFEPRIS, thus speeding up the approval time. However, such service's tend to have higher fees.

Mexican Medical Device Approval Process

1. Determine product classification

2. Specify MRH

3. Approval certificate

4. Specify a distributor

5. Submit application and registration documents

6. Provide test reports

7. Comply with relevant requirements

8. Submit registration files

9. Registration approval

10. Start selling