The Central Drugs Standard Control Organisation (CDSCO) has released a detailed draft guidance on regulatory requirements for medical device software under the Medical Devices Rules (MDR), 2017. The document, dated October 21, 2025, clarifies the scope, classification, technical documentation, and quality management requirements for both domestic and overseas manufacturers.
The guidance distinguishes between Software in a Medical Device (SiMD), which is integrated with hardware, and Software as a Medical Device (SaMD), which operates independently for medical purposes. Risk classification follows MDR-2017 provisions, with SiMD aligned to the hardware’s risk and SaMD classified based on its role in healthcare decisions, ranging from Class A to Class D.
The draft outlines regulatory pathways, clinical investigation requirements, and licensing procedures. Manufacturers must maintain a comprehensive Quality Management System (QMS) and submit detailed technical documentation, including risk management reports and system architecture. Post-market surveillance, adverse event reporting, and corrective actions are mandatory, ensuring patient safety and software reliability. Stakeholders can submit comments within 30 days.