India Risk Classification for Software as Medical Device

Introduction – Software as Medical Device (SaMD) Classification in India

The rapid growth of digital health technologies has significantly transformed the healthcare industry in India. Innovations such as smartwatches, health tracking devices, wearables, telemedicine solutions, and devices incorporating Artificial Intelligence (AI) and Machine Learning (ML) algorithms have become integral to healthcare. The Central Drugs Standard Control Organization (CDSCO) regulates such technologies, referred to as Software as Medical Device (SaMD), under the Medical Device Rules 2017 in India to ensure safety, efficacy, and compliance with established standards.

CDSCO defines SaMD as software intended by its manufacturer for use in humans or animals, which does not achieve its primary action by pharmacological, immunological, or metabolic means, but assists in its intended function. SaMD can be registered either as part of the primary device or as standalone software if it serves specific purposes such as diagnosis, prevention, monitoring, treatment, or alleviation of disease; assisting with injury or disability; supporting life; disinfection of devices; or controlling conception. These guidelines were formalized under the notification S.O. 648(E) on February 11th, 2020, ensuring that both standalone software and software integrated with devices are regulated under the Medical Device Rules 2017 in India.

India is Updating Existing Risk-Based Classifications for Medical Devices

On January 6th, 2025, CDSCO issued a new notification, MED-16014(12)/1/2024-eoffice, updating the classification of medical devices. This draft annexure primarily revisits the existing classifications and adds new devices to align with global regulatory frameworks. However, there are no changes in the classifications for Software as Medical Device (SaMD), which remain consistent with the guidelines established under notification 29/Misc./03/2020-DC (198).

Click here to see the table published by CDSCO to help manufacturers determine the Software equipment classification in India based on their intended use and to streamline the medical device registration in India. The complete classification table for SaMD remains unchanged, and manufacturers are encouraged to refer to the existing CDSCO medical device classification in India guidelines when determining risk classifications for their software products.

Conclusion for Software as Medical Device in India

The CDSCO continues to emphasize a risk-based approach to regulate Software as Medical Device (SaMD) under the Updated CDSCO medical device rules in India. While the new notification MED-16014(12)/1/2024-eoffice introduces updates for other medical device classifications, the risk categories for SaMD remain unchanged. Manufacturers must adhere to the existing guidelines for SaMD classification to ensure compliance with medical device registration in India.

To achieve medical device compliance in India, manufacturers must comply with the Medical Device Rules 2017 in India and classify their software products. If you need assistance understanding the latest regulations or navigating the registration process for Software as Medical Device (SaMD) in India, contact Morulaa. Our consultancy team provides expert guidance to help manufacturers comply with the rules and ensure seamless registration. For more information, reach us at [email protected].