News: MDR/IVDR Revision and Unique Device Identification Codes in China
April 10, 2026
In addition to the MDR/IVDR review, unique device identification codes in China were given a final deadline. Learn more.
Updates, guidance and expert perspectives on regulatory affairs, compliance and market access across Brazil, the United States and Europe.
In addition to the MDR/IVDR review, unique device identification codes in China were given a final deadline. Learn more.
Understand the impacts of the EU MDR IVDR on the European market and the key global regulatory movements shaping the future.
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 it!
What is In Vitro Diagnostics? Discover how IVDs play a vital role in healthcare, the key applications, regulatory pathways, and more.
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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