Aug 24, 2026
MvPI Compliance Alert 2026: New Adverse Event Reporting Rules
IPC's January 2026 directive tightens adverse event reporting for medical device MAHs via ADRMS. Here's what license holders must do…
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Jun 1, 2026
CDSCO SaMD Guidance 2025–26: What India’s Digital Health Companies Must Do Now
CDSCO's October 2025 draft guidance on Medical Device Software is reshaping how SaMD and AI/ML tools are classified and licensed…
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Apr 13, 2026
BA/BE Studies India: New Prior Intimation System Cuts 90 Days
CDSCO's March 2026 reforms introduce prior intimation for BA/BE studies, reducing approval times from 90 to 45 days for faster…
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Mar 30, 2026
India’s NDCT Amendment Rules 2026: Major Regulatory Overhaul
New rules effective March 7, 2026 cut approval timelines from 90 to 45 days. Prior intimation replaces licenses for low-risk…
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