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.
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.
Anvisa has automated the issuance of certificates through the Solicita system. Learn what changes in the Anvisa AFE consultation!
Finding the correct technical name for your IVD in Anvisa’s database can be challenging. Learn how to do it!
Key changes for your biocompatibility strategy.
A practical guide to understand the 2025 update and what it means for your medical device documentation.
ANVISA has introduced a new petition structure for requests involving substances, functions, packaging and physical forms used in personal hygiene
ANVISA has opened a new opportunity for manufacturers of innovative medical devices seeking a clearer regulatory path in Brazil. In
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
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.
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.
Anvisa has automated the issuance of certificates through the Solicita system. Learn what changes in the Anvisa AFE consultation!
Finding the correct technical name for your IVD in Anvisa’s database can be challenging. Learn how to do it!
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