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.
Medical Device Registration at Cofepris: Everything You Need to Know in 2025
How to register medical devices with Cofepris in Mexico. This Blog explains risk classification, documentation, timelines, and tips for national and international companies.
Mexico’s Modernized GMP Guidelines: Advancing Pharmaceutical Regulation
On March 20, 2025, Mexico’s Federal Commission for the Protection Against Health Risks (COFEPRIS) implemented revisions to its Good Manufacturing Practice (GMP) guidelines to align with international regulatory standards and enhance global recognition. These updates are designed to optimize compliance processes, reduce administrative burdens, and strengthen the efficiency and competitiveness of Mexico’s pharmaceutical sector in the global market.
Mexico’s COFEPRIS Enhances New Molecules Committee to Accelerate Pharmaceutical Innovation
Mexico’s Federal Commission for the Protection Against Health Risks (COFEPRIS) has strengthened the expertise of its New Molecules Committee, a key regulatory body responsible for evaluating novel pharmaceutical agents. This initiative aims to enhance evidence-based decision-making, expedite drug approval processes, and expand public access to cutting-edge treatments. By integrating specialized experts, COFEPRIS seeks to streamline regulatory reviews and reinforce Mexico’s role as a leading hub for pharmaceutical research and innovation.
“The inclusion of these specialists will significantly enhance evidence-based decision-making with the highest scientific rigor,” stated COFEPRIS Commissioner Armida Zúñiga Estrada in a 14 March announcement. Furthermore, their work will have a direct impact on the availability of innovative treatments.
Mexico’s Patent Office, COFEPRIS Sign Agreement on Drug Patents
Officials with Mexico’s patent office and its pharmaceutical regulator have signed a new agreement aimed at preemptively clarifying patent protections for drugs in hopes of speeding the review process.
Health Canada Continues to Actively Monitor Supply of Medical Devices
Health Canada’s role in managing medical device shortages in Canada. It explains how the government continuously tracks and updates the list of devices in short supply, ensuring transparency and quick responses to potential shortages. By working closely with manufacturers, importers, and healthcare providers, Health Canada aims to stabilize the supply chain through regulatory adjustments and proactive policies.
IMDRF Releases Key Guidance Documents for Medical Device Software
The International Medical Device Regulators Forum (IMDRF) has released two key guidance documents to support the regulation of medical device software. These include Good Machine Learning Practice for Medical Device Development: Guiding Principles (IMDRF/AIML WG/N88 FINAL:2025) and Characterization Considerations for Medical Device Software and Software-Specific Risk (IMDRF/SaMD WG/N81 FINAL:2025). These documents aim to enhance global regulatory harmonization and assist medical device manufacturers in navigating compliance requirements for software-based and AI-driven technologies.
EMA Launches Early Scientific Advice Program for High-Risk Medical Devices
The European Medicines Agency (EMA) has launched a new Early Scientific Advice (ESA) program aimed at supporting the development of high-risk medical devices. This initiative seeks to provide manufacturers with timely regulatory guidance, ensuring that innovative medical technologies meet the necessary safety and efficacy standards before reaching the market.
Stakeholders Ask FDA to Harmonize Guidelines for Oligonucleotide-Based Therapies
The biopharmaceutical industry and other stakeholders are pressuring the US Food and Drug Administration (FDA) to harmonize its regulatory guidelines for oligonucleotide-based therapies. The request aims to eliminate discrepancies in the development, manufacturing and approval requirements for these innovative treatments, which have shown great potential in the fight against various genetic and infectious diseases.
Health Canada Makes Clinical Information on Medical Devices Publicly Accessible
Health Canada Makes Clinical Information on Medical Devices Publicly in a significant move toward greater transparency in healthcare, Health Canada (HC), the country’s medical device regulator, has announced that clinical information submitted in support of medical device applications is now publicly available. This development marks a crucial step in empowering healthcare professionals, researchers, and the general public with access to critical data.
FDA Proposes Framework to Bolster Credibility of AI Models in Drug Development
The U.S. Food and Drug Administration (FDA) has unveiled a groundbreaking draft guidance aimed at advancing the credibility of artificial intelligence (AI) models in drug and biological product development. This marks a significant milestone as it is the agency’s first formal guidance on AI in this domain, underscoring its commitment to innovation while maintaining rigorous regulatory standards.
FDA Suggests Collecting data on Ovarian Toxicity in Cancer Drug Trials
The US Food and Drug Administration (FDA) is recommending that sponsors include the collection of data on ovarian toxicity in the development of cancer drugs.