Mexico Medical Device Regulation

COFEPRIS Medical Device Registration in Mexico: Regulations, Process, and Market Insights

Updated on 26/01/24

Regulatory Authority: Comision Federal para la Proteccion contra Riegos Sanitarios (COFEPRIS)

The mission of COFEPRIS is to protect the population from health risks arising from the use and consumption of goods and services, exposure to environmental and work factors, health emergencies, and the provision of health services through regulation, control, and prevention.

Mexico aims to establish a reliable national authority for health risk protection, focusing on technical, operational, and regulatory capacity, as well as staff development.

COFEPRIS will establish and implement policies, programs, and projects at the best international practice level, in effective coordination with public, private, and social actors.

Link for Regulatory Authority: https://www.gob.mx/cofepris

Local Regulation: https://www.gob.mx/cms/uploads/attachment/file/863392/Estrategia_de_Certidumbre_Regulatoria_dispositivos_medicos_oct2023__1_.pdf

• The General Health Law;
• The Health Law Regulations; and
• Official Mexicans Standards (NOMs)

Classification: Class I, II and III

Listing or Registration Requirements:

• Appoint a Mexico Registration Holder (MRH) who will coordinate device submissions. This may be a distributor or third-party company, but registration holder controls device registration and transferring registration is difficult and time consuming. Ensure your registration holder is long term.
• Demonstrate home country approval through Certificate of Free Sale (CFS) or Certificate to Foreign Government (CFG).
• Device must comply with ISO 13485 or equivalent in another country. No audit will be performed.
• Submit a registration dossier, which should include safety information, testing reports, clinical trial data. Approval from recognized country (Japan, Canada, or United States) may be leveraged to expedite approval
• If the device is approved COFEPRIS will issue the certificate and post confirmation of device registration on the Ministry of Health website.

Documents Required:

• Technical and scientific information to demonstrate that the medical device meets the characteristics of safety and efficacy
• Draft label in Spanish
• Instruction for use or operating manual in Spanish
• General description of the manufacturing process
• Description of the structure, materials, parts, and functions, if applicable.
• Testing reports to verify the specifications of the medical device
• Free sale certificate or equivalent, issued by the health authority of the country of origin
• Letter of representation of the manufacturer in Mexico (POA)
• Certificate of good manufacturing practices issued by the health authority of the country of origin (ISO 13485)
• Certificate of Analysis or declaration of conformity issued by manufacturers on letterhead and signed by the quality
• manager
• Notice of operation and sanitary responsible
• Copies of approval in reference countries (FDA for US or Health Canada for Canada or MHLW for TGA).
• Monograph issued by the manufacturer

Registration Timeline:

• Standard Route: 3-6 months (excluding time to respond feedback/request from COPEFRIS).
• Expedited Route (Third Party Route-TPR): 2-5 months (excluding time to respond feedback/request from COPEFRIS).
• Equivalency Route (Applicable for all medical devices approved in the US, Canada, and Japan): 3-8 months (excluding time to respond feedback/request from COPEFRIS)
• Specific Route for certain Class I (Low-Risk Medical Devices) products: 1-3 months.

Registration Fee:

• Class I – USD 630
• Class II – USD 920
• Class III – USD 1170
• Expedited Route: Fees vary from USD 2935 – USD 5870 as it set by the third party and depending on the device classification.

License Validity: 5 Years

License Renewal: Must be submitted under the same route as the original registration, no later than 150 calendar days before the expiration date.

Special Labelling Requirements: Labelling must be in Spanish

Additional Comments:

• In addition to the registration certificate, an import permit is also required for products such as Class III and implantable devices. Translation to Spanish is no longer mandatory for technical documents that are provided in English.
• All documents included in registration dossier shall be translated in

Who should make this communication:

• Manufacturer
• Authorized Representative

When to make this communication: Before placing a medical device into the market.

 Market overview:

Projected to hit US$8.09 billion in 2024, the revenue in Mexico’s Medical Devices market is led by the Cardiology Devices segment, with an estimated market volume of US$1.28 billion in the same year. Anticipating a steady annual growth rate (CAGR 2024-2028) of 4.70%, the industry is poised to achieve a market volume of US$9.72 billion by 2028.

How OMC Medical can assist you with the process

• Act as your Authorized representative

Why Choose Us

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: [email protected]