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.
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
Anvisa advances its Regulatory Sandbox initiative for personalized cosmetics while global regulators strengthen post-market surveillance.
In the development and approval process of medical devices, three types of evaluations frequently appear in regulatory requirements:
In addition to the MDR/IVDR review, unique device identification codes in China were given a final deadline. Learn
Learn how cosmetic registration works in the main global markets, including the U.S., EU, and Brazil, and plan
Understand the concept of regulatory reliance and how initiatives from IMDRF, FDA, and Anvisa are impacting global regulation.
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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