News: Regulatory impacts of the EU MDR IVDR and more
January 30, 2026
Understand the impacts of the EU MDR IVDR on the European market and the key global regulatory movements
Updates, guidance and expert perspectives on regulatory affairs, compliance and market access across Brazil, the United States and Europe.
Understand the impacts of the EU MDR IVDR on the European market and the key global regulatory movements
While the FDA strengthens cosmetic recalls, the EU and China are making important regulatory updates.
Entering the U.S. medical device market can be a major opportunity for international companies. However, to operate legally
The FDA has published a new guideline aligned with ICH Q3E to support the assessment of Extractables &
Check out the main regulatory news of the week, including FDA ISO 13485 harmonization via QMSR, Anvisa, and
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
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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