India, July 27 -- image credit- freepik

Software role in healthcare is becoming increasingly critical, as a diverse array of products serves various medical and administrative functions across clinical and private settings. Any software, whether alone or in combination, intended by the manufacturer for medical purposes and attracts the definition of medical device under the Drugs and Cosmetics Act, 1940 and Medical Devices Rules, 2017 (MDR-2017) is regulated as 'medical device.'

The Central Drugs Standard Control Organisation (CDSCO) has released a document to provide guidance to stakeholders (manufacturers, importers and innovators/researchers, etc.) for the submission of application to the Licensing Authority (LA) for obtaining regula...