The Central Drugs Standard Control Organisation (CDSCO) has issued a draft guidance document on medical device software to bring more clarity on the regulatory aspects of their usage. The document, which aims to “align the regulatory requirements” with the globally harmonised practices, provides a roadmap to the domestic device makers and importers to obtain licence for medical device software – including in vitro diagnostic (IVD) medical device software – under the Medical Devices Rules (MDR), 2017.
“This guidance document provides scope, definition, classification, standards, requirements of technical documents, and quality management system applicable for medical device software. The applicants may refer to the documents during submission of application for grant of licence to manufacture or import medical device software for sale and distribution in the country,” said Rajeev Singh Raghuvanshi, the Drug Controller General of India (DCGI).
As per the CDSCO, the software has been categorised into two broad areas: software in a medical device (SiMD) and software as a medical device (SaMD). The note elaborates on the devices that fall under these two categories. While the SiMD refers to software that are considered as a “part of” the medical device hardware and that drive or influence the use of that medical device, SaMD is a “standalone software” which is “not embedded” into a hardware medical device. Mobile apps, AI/ML-based software and cloud-based software that do not drive or influence the use of another hardware medical device is considered as SaMD.
Experts said that medical device software is an emerging area globally that has still not been fully understood by the regulators. In India too, CDSCO had released the first of guidelines around them in mid-2025, and the latest guidelines are updated based on the industry feedback.
According to EY, the Indian MedTech market, valued at $12 billion in FY24, is projected to reach $50 billion by 2030, with India’s global market share set to grow from 1.65% to 10-12% over the next 25 years. There is no separate estimate available for the medical device software segment.
“The latest guidelines cover a lot more areas. There was a lack of clarity around the definition of software as a medical device as people were unclear whether healthcare informatics and mobile apps were under this regulation,” said Rajiv Nath, forum coordinator at Association of Indian Medical Device Industry (AiMeD).
“By providing clarity on definitions, classification, and quality management requirements, the new guidelines create a foundation for safe, innovative, and globally competitive MedTech software solutions from India,” said Pavan Choudary, chairman of Medical Technology Association of India (MTaI).
Despite the fresh set of guidelines, experts said that technologies like AI are increasingly being used in MedTech sector, requiring the regulator to update these guidelines further. “These guidelines would need a revision to take into account the growing use of AI. Also, more clarity is needed on clinical evaluation protocols and algorithm change management, particularly for AI/ML-based medical devices,” said an expert.
In India, the medical device software have to conform to the standards laid down by the Bureau of Indian Standards (BIS) or as may be notified by the Ministry of Health and Family Welfare. In case no such standards are available, the devices have to conform to the International Organisation for Standardisation (ISO) or the International ElectroTechnical Commission (IEC), or by any other pharmacopeial standards.