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.
In the development and approval process of medical devices, three types of evaluations frequently appear in regulatory requirements:
Learn how the updated ISO 10993-1 impacts biological risk assessments, gap analysis, documentation, and compliance for medical devices.
Learn how to conduct Biological Evaluations for Medical Devices using ISO 10993. Follow essential guidelines to ensure safety
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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