COFEPRIS Mexico Simplifies Procedures: A New Era for Healthcare Product Registration
In a historic move for the Latin American healthcare sector, COFEPRIS (Mexico) has announced administrative simplification measures to eliminate bureaucratic bottlenecks. As of May 4th, 2026, the entry of health technologies into the country will be accelerated through digital processes and Reliance mechanisms. For GRP Mexico clients, this change is even more advantageous due to our direct presence in the country.
The Future of Digital Health: ANVISA and the New Era of AI in Software as a Medical Device (SaMD)
This Blog details the revision of RDC No. 657/2022 by ANVISA, driven by the rise of Generative AI. We discuss how new risk classification criteria impact the development of software that diagnoses and suggests treatments, ensuring patient safety without stifling innovation.
Brazil and Mexico: A New Era of Sanitary Integration and Innovation in Latin America
This article explores the recent strengthening of bilateral cooperation between the regulatory agencies of Brazil and Mexico. The central focus is the harmonization of standards to accelerate the registration of medicines and medical devices, while fostering regional biotech innovation hubs.
Mexico Strengthens Health Security: The Transition from the CNFV to the New CENAFyT
Mexico has taken a decisive step in modernizing its healthcare system with the creation of the National Center for Pharmacovigilance and Technovigilance (CENAFyT). Integrated into the General Health Law, this new body expands supervisory powers over both medicines and medical equipment, ensuring greater protection for all citizens.
The New period of Regulation in Mexico: Modernization and Sovereignty (2024–2026)
Between 2024 and 2026, Mexico underwent a profound transformation of its regulatory landscape for medicines and vaccines. Led by COFEPRIS, this shift focuses on agility through the “regulatory reliance” model, ensuring that medical innovation reaches patients faster without compromising scientific rigor or national sovereignty.
COFEPRIS Introduces Abbreviated Regulatory Pathway (“Reliance”) to Accelerate Health Product Approvals in Mexico
On 2025, the Mexican Federal Commission for Protection against Sanitary Risks (COFEPRIS) published a new regulatory framework in the Diario Oficial de la Federación (DOF) establishing an abbreviated regulatory pathway for sanitary licenses of health products. This mechanism is grounded in the concept of regulatory reliance, whereby COFEPRIS recognizes the evaluation outcomes of trusted foreign regulatory authorities (Reference Regulatory Authorities – RRAs) as the basis for its own approval decisions.
Leadership Transition at COFEPRIS: Regulatory Consistency Risks and the Need for Stability
The Federal Commission for the Protection against Sanitary Risks (COFEPRIS) is Mexico’s national regulatory authority responsible for protecting public health by overseeing medicines, medical devices, food products, tobacco, and other health-related inputs. COFEPRIS plays a central role in ensuring product safety, authorizing market access, and establishing technical regulatory requirements across the country.
Strategic Alliance in Mexico: COFEPRIS and CCINSHAE Join Forces to Strengthen Patient Safety
This blog details the recent agreement signed between the Federal Commission for Protection against Sanitary Risks (COFEPRIS) and the Coordinating Commission of National Institutes of Health and High Specialty Hospitals (CCINSHAE). The primary objective is to optimize the detection of adverse reactions and medical device incidents within the most complex health institutions in the country.
Strengthening Health in Latin America: Brazil and Mexico Join Forces in Historic Agreements
In a strategic move to strengthen public health in Latin America, Brazil and Mexico are advancing negotiations to sign important bilateral agreements. Preliminary discussions, which took place in August, involved a Brazilian delegation led by Vice President Geraldo Alckmin and the Mexican government, led by President Claudia Sheinbaum. The main focus of these agreements is cooperation in key areas such as vaccines, medicines, and regulatory harmonization. The final agreements are expected to be signed in 2026.
Anvisa’s Regulatory Agenda and Strategic Plan
This Blog analyzes the importance of ANVISA’s 2024-2025 Regulatory Agenda and its 2024-2027 Strategic Plan for companies operating in regulatory affairs. The text explains how these documents serve as a planning guide, helping companies anticipate new regulations and align their strategies to ensure compliance and operational efficiency.
COFEPRIS: Self-Verification Guide for Warehouses Storing and Distributing Medicines and Other Health Supplies
Mexico’s health regulatory authority, COFEPRIS, has published a Self-Verification Guide designed for companies operating warehouses that store and distribute medicines and other health-related supplies. This initiative aims to strengthen compliance with sanitary regulations, standardize procedures, and help businesses identify nonconformities—ultimately improving safety and traceability across the supply chain.
COFEPRIS x FDA: What Are the Key Differences in Medical Device Regulatory Pathways?
Companies looking to commercialize medical devices internationally often target two major markets: the United States and Mexico. These countries are regulated by two robust authorities — the FDA (Food and Drug Administration) in the U.S. and COFEPRIS (Federal Commission for Protection against Sanitary Risks) in Mexico — each with distinct regulatory frameworks.
Understanding the differences between FDA and COFEPRIS approval processes is essential for planning efficient market entry, minimizing risks, and reducing time-to-market. In this blog post, we provide a clear comparison of both regulatory systems, including requirements, timelines, and strategic advantages.