23/09/2026
The CDSCOโs Guidance Document on Medical Device Software provides important clarity on the regulatory framework for Medical Device Software (MDSW) under the Medical Devices Rules, 2017, covering software development, risk classification, clinical evidence, cybersecurity and post-market compliance.
๐๐๐ฒ ๐ญ๐๐ค๐๐๐ฐ๐๐ฒ๐ฌ:
โข The regulatory status of software depends primarily on its intended medical purpose.
โข AI/ML, SaaS, cloud-based and connected software may qualify as MDSW where they perform medical functions.
โข MDSW follows a risk-based classification from Class A to Class D.
โข Manufacturers must maintain a Quality Management System covering the software lifecycle, including cybersecurity and updates.
โข Clinical evidence, verification and validation must support the softwareโs safety, performance and intended use.
โข The Guidance emphasises cybersecurity, version control and traceability throughout the software lifecycle.
โข Post-market compliance includes AI/ML drift monitoring, cybersecurity, adverse-event reporting and corrective actions.
In this article, Manisha Singh and Shivi Gupta examine the CDSCO Guidance and its implications for regulating and managing the lifecycle of Medical Device Software, including AI/ML-enabled products.
Read more: https://www.lexorbis.com/cdsco-issues-guidance-on-medical-device-software-under-the-medical-devices-rules-2017/