Artixio’s Product Registration Services in Mexico

Streamlining your product registration journey in Mexico with local expertise.

Services We Offer

Product Registration Support In Mexico for Life Sciences

Artixio helps life sciences companies with Mexico’s product registration process. With our knowledge of local regulations, we guide you through every step to meet compliance requirements and achieve faster market entry.

Regulatory Authority in Mexico

In Mexico, product registration is managed by the Federal Commission for the Protection against Sanitary Risks (COFEPRIS). This regulatory body is responsible for verifying that products, including pharmaceuticals, medical devices, and other life sciences items, comply with the country’s health and safety regulations.

COFEPRIS is central to the approval process, ensuring products comply with local standards before they can enter the Mexican market.

Registration Process in Mexico

Pre-Registration Consultation
Product Classification
Document Preparation
Submission to COFEPRIS
Review and Evaluation
Approval and Market Authorization
Post-Market Surveillance

Why Partner with Artixio for Product Registration in Mexico?

Over 15 years of experience in helping life sciences companies enter the Mexican market.
Dedicated local experts with in-depth knowledge of COFEPRIS and its requirements.
Comprehensive compliance strategies to meet all local regulations and requirements.
End-to-end services from document preparation to post-market surveillance.
Strong network with regulatory authorities to streamline the approval process.

FAQs

Can Artixio assist with product registration for both new and existing products in Mexico?

Yes, Artixio provides support for both new product registrations and renewals or updates for existing products. We assist with re-evaluations, re-registration, and changes to the product dossier as required by COFEPRIS.

What is the role of COFEPRIS in the product approval process in Mexico?

COFEPRIS is the primary regulatory authority responsible for overseeing the registration and approval of healthcare products in Mexico. It ensures that all products meet local safety, efficacy, and quality standards before they are approved for sale.

How do local regulatory requirements in Mexico differ from other countries?

Mexico has specific regulatory requirements that can differ from other countries, particularly in terms of documentation, labeling, and safety data for certain products. Additionally, COFEPRIS requires specific certifications and proof of local manufacturing or authorized representation, which may not be required in other regions.

Can Artixio assist with registration for imported products in Mexico?

Yes, Artixio supports the registration of both local and imported products. We assist with the necessary documentation, importation procedures, and ensuring that all local regulatory requirements for imported products are met by COFEPRIS.