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The Central Drugs Standard Control Organisation (“CDSCO”) has issued the final Guidance Document on Medical Device Software under the Medical Devices Rules, 2017 (“MDR-2017”). The Guidance Document provides greater clarity on the regulation of medical device software in India.
The Guidance Document clarifies the regulatory framework applicable to medical device software, including Software as a Medical Device (“SaMD”), Software in a Medical Device (“SiMD”) and software associated with in vitro diagnostic medical devices.
More importantly, the Guidance Document recognises General Wellness Software, promoting a healthy lifestyle or measuring body parameters only for regular tracking and fitness purposes. It defines General Wellness Software as any software that is:
- intended to maintain or encourage a general state of health or a healthy activity, and/or
- relates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions.
While General Wellness Software is excluded from the purview of medical devices, the Guidance Document states that the intended use statement of such General Wellness Software may make claims about sustaining or offering general improvement to functions associated with a general state of health. The General Wellness Software shall however not make any reference to diseases or disorders or pathological conditions. Software intended to measure, estimate, or report physiologic values for medical or clinical purposes, including screening, diagnosis, monitoring, alerting, or management of a disease or a disorder or a condition would also not be considered as General Wellness Software.
The Guidance Document also introduces:
- a dedicated risk classification framework for SaMD;
- software-specific requirements for lifecycle management, cybersecurity, technical documentation and post-market surveillance;
- Software Bill of Materials requirements for software traceability and cybersecurity;
- an Algorithm Change Protocol for anticipated software and algorithm changes;
- interoperability with India's digital health ecosystem through the Ayushman Bharat Digital Mission;
- software-specific documentation requirements for regulatory submissions; and
- a framework for the regulatory treatment of major and minor post-approval software modifications.
Overall, the Guidance Document provides greater regulatory certainty for manufacturers, developers and importers of medical device software under the MDR-2017.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
