CDSCO issues draft guidance document on conduct and regulation of medical device software

Software Is Becoming the New Stethoscope — India’s SaMD Guidance Arrives Just in Time

India’s healthcare system is undergoing its most significant digital shift since the arrival of telemedicine. With AI-enabled diagnostics, remote monitoring, digital therapeutics, and algorithm-driven decision support now entering routine care, software is no longer supporting healthcare — it is increasingly delivering healthcare. Recognising this transformational moment, the Central Drugs Standard Control Organisation (CDSCO) has issued […] The…

CDSCO issues draft guidance document on conduct and regulation of medical device software

The Central Drugs Standard Control Organization (CDSCO) has released a draft guidance document on the conduct and regulation of Medical Device Software (MDSW) under the Medical Devices Rules (MDR), 2017 with an aim to clarity on regulatory requirements for medical device software and align India’s framework with globally harmonized practices.  The guidance outlines comprehensive provisions related to the scope, definitions, classification, appli…