Updates, guidance and expert perspectives on regulatory affairs, compliance and market access across Brazil, the United States and Europe.
Entering the U.S. medical device market can be a major opportunity for international companies. However, to operate legally and safely, companies must meet FDA requirements. One
Check out the main regulatory news of the week, including FDA ISO 13485 harmonization via QMSR, Anvisa, and TGA.
Learn how the Modernization of Cosmetics Regulation Act (MoCRA) transforms industry standards and how to achieve FDA compliance.
Discover a step-by-step guide to FDA medical devices approval, outlining the process, requirements, and key considerations for manufacturers.
Key changes for your biocompatibility strategy.
A practical guide to understand the 2025 update and what it means for your medical device documentation.
Understand how ANVISA’s RDC No. 1,030/2026 may impact cosmetic formulations, product portfolios, and regulatory compliance deadlines in Brazil.
Anvisa advances its Regulatory Sandbox initiative for personalized cosmetics while global regulators strengthen post-market surveillance.
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,
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
Understand the concept of regulatory reliance and how initiatives from IMDRF, FDA, and Anvisa are impacting global regulation.
The UK regulatory authority opens a consultation on CE mark recognition and highlights other key global regulatory updates.
Entering the U.S. medical device market can be a major opportunity for international companies. However, to operate legally and safely,
Check out the main regulatory news of the week, including FDA ISO 13485 harmonization via QMSR, Anvisa, and TGA.
Learn how the Modernization of Cosmetics Regulation Act (MoCRA) transforms industry standards and how to achieve FDA compliance.
Discover a step-by-step guide to FDA medical devices approval, outlining the process, requirements, and key considerations for manufacturers.
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