Regulatory Affairs Consulting Services in Mexico

Get expert support for regulatory affairs in Mexico across the life sciences sector. We simplify compliance so you can focus on your product’s success.

Services We Offer

Enter the Mexican Market with Regulatory Compliance

Mexico is one of the largest healthcare markets in Latin America after Brazil, with growing demand for advanced therapies and pharmaceutical solutions. This presents a strong global opportunity for companies looking to enter the market. The product approval process in Mexico involves meeting defined regulatory standards before products can be introduced. Artixio offers regulatory affairs solutions in Mexico to support companies through local requirements and registration procedures.

COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios), the Mexican regulatory affairs authority was established in 2001. It works under Mexico’s Ministry of Health and is responsible for the regulation of safety, efficacy and quality of health-related products in Mexico. It requires a strict multi-step process to launch any healthcare product in Mexico.

COFEPRIS is recognized by the Pan American Health Organization (PAHO) as a National Regulatory Authority (NRA) of regional reference. This helps other Latin American countries for regulatory approvals and decreases redundant reviews. It elevates COFEPRIS as a benchmark regulator in the region, making Mexico as a key entry point for pharmaceutical companies looking to enter Latin America.

Artixio, a trusted regulatory affairs company in Mexico, supports businesses in launching their products without hassles by providing strategic services for registration and approvals.

Regulatory Authorities in Mexico

Regulatory Affairs Lifecycle in Mexico

The first technical checkpoint is to analyse the correct classification and regulatory pathway for the product. COFEPRIS assesses the classification based on composition, primary mechanism of action, intended use, and route of administration.

Medical devices are classified into four risk classes (Class I to IIIb).
Pharmaceuticals are categorized as new molecules, generics, OTCs, or biocomparables.
Nutritionals and cosmetics are further distinguished as either regulated or exempt products, based on ingredients and claims.

Compile a structured dossier with localized content which includes the following:

Administrative forms
Product composition and labeling
Manufacturing process and site information
Certificates of Free Sale (for imported goods)
GMP certificates (from recognized NRAs or via direct COFEPRIS inspection)
Quality testing reports
Clinical evidence or performance studies (if applicable)
Sample packaging or mock-ups

All documents must be submitted in Spanish, including translation of original SmPCs, labels, and technical data.

Note:

For Medical Devices: the dossier must also include risk classification, QMS documentation, and a technical file equivalent to STED.
For pharmaceuticals and Biologics: Clinical trial data is required, depending on the status of global approvals.
For nutritionals, cosmetics, and veterinary products: COFEPRIS has different templates and forms for these. However, all submissions must include safety justification, labeling proposals, and a valid Certificate of Free Sale from the country of origin.

It is important for all foreign companies to appoint a Mexican Registration Holder (MRH). MRH is responsible for maintaining the regulatory license and is accountable for COFEPRIS regulatory compliance.

It is important for manufacturing sites to be GMP-compliant for imported products. Note that the site registration should be done before or concurrently with the product registration.

Submit the dossier to COFEPRIS which then goes through a completeness evaluation followed by a technical evaluation (if the application is complete). Additional information is requested by issuing a deficiency letter, in case of data incompleteness. Also, they may ask for clarifications, additional data, or corrected translations during review.

COFEPRIS grants a Sanitary Registration Certificate (Registro Sanitario) with a unique alphanumeric (Sanitary Registration Number) code after a successful review.

This number should reflect on the secondary packaging, Instructions For Use (IFU), and marketing materials. For medical devices, it should also be included in import documentation.

Post marketing compliance is mandatory for products after launching in the market. It is important to report Adverse events, Periodic Safety Update Reports (PSURs) submissions, notification to COFEPRIS if there is any modification in labeling, shelf life, etc. It is also necessary to renew the product license every five years and it should be filed at least 90 days before expiry.

Why Artixio for Regulatory Affairs in Mexico

Partner with Artixio today to register your product with precision. Our team of experts supports and manages your regulatory filings in Mexico with compliance. Contact our Regulatory Affairs consultant in Mexico today to register your product without delays.

FAQs

What are the two possible routes for GMP compliance?

There are two possible routes including:

Recognition-based pathway: COFEPRIS accepts the registration under mutual recognition if the facility has GMP certification from the FDA, EMA, Health Canada, or other recognized agencies.
Direct inspection pathway: COFEPRIS conducts its own inspection of the facility, particularly for high-risk pharmaceuticals or biologics.

Can we use a third-party for our MRH?

Yes, you can appoint a local entity such as Artixio as your MRH or work with a partner designated through a formal agreement.

Are there any specific labeling requirements in Mexico?

Yes, all products must comply with COFEPRIS and SAGARPA regulations for labeling. This includes ensuring proper translations, ingredient disclosures, and health claims that align with Mexican health standards.

What types of products require COFEPRIS approval?

COFEPRIS regulates pharmaceuticals, biologics, medical devices, health supplements, cosmetics, and certain food products. Each category has specific submission and approval requirements.

Do all sites need COFEPRIS inspection?

If your facility is GMP-certified by a recognized agency (such as FDA, EMA), it may not be required.

Can I market my product in Mexico if it is approved in another country?

Approval in another country may streamline the process, but Mexican authorities require a separate approval. Artixio helps adapt your existing documentation for local compliance.

How can I maintain regulatory compliance in Mexico once my product is approved?

We help you stay compliant through regular reviews and updates on Mexican regulations. Artixio also assists with post-market surveillance and reporting requirements to ensure continued market access.