Updates, guidance and expert perspectives on regulatory affairs, compliance and market access across Brazil, the United States and Europe.
Generative AI medical devices are moving into a new regulatory phase. In its 2026 discussion paper, the FDA examines how risk, evidence, postmarket monitoring and third-party
Learn more about the FDA’s regulatory framework for AI-powered medical devices and other global recent updates.
In the development and approval process of medical devices, three types of evaluations frequently appear in regulatory requirements: biological evaluation, clinical evaluation, and toxicological evaluation. Although
In addition to the MDR/IVDR review, unique device identification codes in China were given a final deadline. Learn more.
Alternatives for cosmetic animal testing advance with new FDA guidance and other global updates.
Learn how cosmetic registration works in the main global markets, including the U.S., EU, and Brazil, and plan a safe export strategy.
Understand the concept of regulatory reliance and how initiatives from IMDRF, FDA, and Anvisa are impacting global regulation.
Global updates on MDR and IVDR, the QMSR in the U.S., and new regulatory requirements for cosmetics in China and the U.S. market.
Key changes for your biocompatibility strategy.
A practical guide to understand the 2025 update and what it means for your medical device documentation.
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