Medical Device As Software: Has CDSCO Guidance Changed The Rules?

Key Points:

• The CDSCO's Draft Guidance on Medical Device Software clarifies the application of existing Medical Devices Rules to software without introducing new regulatory requirements.
• It distinguishes between Software in a Medical Device (SiMD) and Software as a Medical Device (SaMD), providing a risk-based classification framework for SaMD based on its clinical impact.
• The guidance aims to reduce regulatory uncertainty for software developers while ensuring patient safety, reflecting a structured approach to the evolving digital health landscape.

Background: The Central Drugs Standard Control Organisation (CDSCO) issued the Draft Guidance on October 21, 2025, to address regulatory ambiguities surrounding medical device software in India. This follows the inclusion of software under the definition of "drug" in the Drugs and Cosmetics Act, 1940, and ongoing judicial scrutiny regarding its classification and regulation.

What's Next: The final form of the Draft Guidance is anticipated following stakeholder consultations, with expectations for its implementation to clarify regulatory processes for medical device software.