News: Automatic issuance impacts Anvisa AFE consultation and more!
October 24, 2025
Anvisa has automated the issuance of certificates through the Solicita system. Learn what changes in the Anvisa AFE
Updates, guidance and expert perspectives on regulatory affairs, compliance and market access across Brazil, the United States and Europe.
Anvisa has automated the issuance of certificates through the Solicita system. Learn what changes in the Anvisa AFE
Malaysia joins MDSAP, expanding global audits. Plus: FDA software guidance, IMDRF PCCP guideline, and Anvisa’s new import process.
Finding the correct technical name for your IVD in Anvisa’s database can be challenging. Learn how to do
Learn how in vitro testing cosmetics provides ethical and scientifically relevant methods to ensure safety without animal testing.
What is In Vitro Diagnostics? Discover how IVDs play a vital role in healthcare, the key applications, regulatory
Proven steps for Quality Control Medical Devices and how a robust QMS aligned with ISO 13485:2016 can help
Understand the essential role of PMS in ensuring compliance with MDR 2017/745 and its impact on medical device
Discover the key differences between MDR 2017/745 and ISO 13485 in quality management for medical devices.
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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