Insights
India vs US vs EU Medical Device Approval Pathways A Practical Comparison for Manufacturers
When medical device companies plan international market entry, one of the most...
Read More
Understanding Predicate Device Challenges for Novel SaMD Products under CDSCO
Software as a Medical Device (SaMD) is increasingly important in healthcare innovation,...
Read More
FSC Rejection Due to Undeclared Post-Approval Modifications
Introduction A Free Sale Certificate (FSC) is often the final regulatory milestone...
Read More
Manufacturing Site Changes and Their Impact on Existing Licenses
In the medical device regulatory lifecycle, approval is not the finish line...
Read More