<p>In-depth guides, explainers, and comprehensive resources on regulatory affairs, licensing processes, and compliance frameworks in India.</p>
CDSCO has tightened post-market surveillance for medical devices in 2026 — new MDSW guidance, 48-hour recall rules, and risk-based audits.…
Read MoreCDSCO's new Prior Intimation pathway and interim import procedures are reshaping BA/BE study timelines in India. Here's what sponsors and…
Read MoreIPC's January 2026 directive tightens adverse event reporting for medical device MAHs via ADRMS. Here's what license holders must do…
Read MoreCDSCO's October 2025 draft guidance on Medical Device Software is reshaping how SaMD and AI/ML tools are classified and licensed…
Read MoreCDSCO's March 2026 reforms introduce prior intimation for BA/BE studies, reducing approval times from 90 to 45 days for faster…
Read MoreNew rules effective March 7, 2026 cut approval timelines from 90 to 45 days. Prior intimation replaces licenses for low-risk…
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