The Central Drugs Standard Control Organization (CDSCO), on July 2026, issued the Guidance Document on Medical Device Software (MDSW) to provide regulatory guidance for manufacturers, importers, innovators, and researchers seeking approvals for Medical Device Software, including In Vitro Diagnostic (IVD) Medical Device Software, under the Medical Devices Rules, 2017 (MDR-2017). The document clarifies that it is intended for guidance and does not introduce any new regulatory controls.
The guidance outlines the scope, definitions, intended use, risk-based classification, applicable standards, quality management system (QMS) requirements, licensing authorities, regulatory pathways, and documentation requirements for the manufacture, import, clinical investigation, and marketing of Medical Device Software. It also distinguishes software regulated as a medical device from general wellness and fitness software that falls outside the scope of the MDR-2017.
The document specifies that test licence applications for Medical Device Software must be submitted through the National Single Window System (NSWS), while commercial permissions, manufacturing/import licences, and registration applications must be filed through the CDSCO Medical Devices Online Portal. It also provides detailed guidance on clinical investigations, post-marketing regulatory requirements, and document checklists to facilitate regulatory compliance.
[Doc No. CDSCO/MD/GD/MDSW/01/2026]
