New Delhi: Industry bodies on Wednesday welcomed the draft guidance on medical device software issued by the Central Drugs Standard Control Organisation (CDSCO).

Medical device software is software that is either integrated into a hardware medical device (Software in a Medical Device or SiMD) or operates independently as a standalone application for medical purposes (Software as a Medical Device or SaMD).

The CDSCO, in an official notice on Tuesday, shared the draft of the guidance document to bring more clarity on regulatory aspects of medical device software and to align the requirements with best global practices.

“This guidance document provides scope, definition, classification, standards, requirements of technical documents, and Quality Management system applicable for Medical De

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