News: MDR and IVDR Under Review, QMSR in Force, and More
February 13, 2026
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.
Updates, guidance and expert perspectives on regulatory affairs, compliance and market access across Brazil, the United States and Europe.
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.
Understand the impacts of the EU MDR IVDR on the European market and the key global regulatory movements shaping the future.
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
The FDA has published a new guideline aligned with ICH Q3E to support the assessment of Extractables & Leachables (E&L), along with supporting documentation that includes
Check out the main regulatory news of the week, including FDA ISO 13485 harmonization via QMSR, Anvisa, and TGA.
Learn how the updated ISO 10993-1 impacts biological risk assessments, gap analysis, documentation, and compliance for medical devices.
Discover the truth behind the “Anvisa bans fiberglass nails” topic and explore other important regulatory updates.
Learn how to navigate the Anvisa medical device registration process and bring your product to the Brazilian market with confidence.
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.
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.
Understand the impacts of the EU MDR IVDR on the European market and the key global regulatory movements shaping the future.
Entering the U.S. medical device market can be a major opportunity for international companies. However, to operate legally and safely,
The FDA has published a new guideline aligned with ICH Q3E to support the assessment of Extractables & Leachables (E&L),
Check out the main regulatory news of the week, including FDA ISO 13485 harmonization via QMSR, Anvisa, and TGA.
Learn how the updated ISO 10993-1 impacts biological risk assessments, gap analysis, documentation, and compliance for medical devices.
Discover the truth behind the “Anvisa bans fiberglass nails” topic and explore other important regulatory updates.
Learn how to navigate the Anvisa medical device registration process and bring your product to the Brazilian market with confidence.
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