News: ISO 10993-1:2025 Is Now ABNT NBR – What It Means for ANVISA
October 14, 2026
ISO 10993-1:2025 is now ABNT NBR in Brazil. See what changes in biological evaluation for ANVISA registration.
Updates, guidance and expert perspectives on regulatory affairs, compliance and market access across Brazil, the United States and Europe.
ISO 10993-1:2025 is now ABNT NBR in Brazil. See what changes in biological evaluation for ANVISA registration.
Your devices have been on the EU market for years. They have valid certificates, a technical file and
Generative AI medical devices are moving into a new regulatory phase. In its 2026 discussion paper, the FDA
ANVISA has introduced a new petition structure for requests involving substances, functions, packaging and physical forms used in
ANVISA has opened a new opportunity for manufacturers of innovative medical devices seeking a clearer regulatory path 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.
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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