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Top Healthcare India News

CDSCO issues draft guidance document on conduct and regulation of medical device software

Regulation · India

CDSCO issues draft guidance document on conduct and regulation of medical device software

The Central Drugs Standard Control Organization (CDSCO) has released a draft guidance document on the conduct and regulation of Medical Device Software (MDSW) under the Medical Devices Rules (MDR), 2017 with an aim to clarity on regulatory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…See the Story

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