10 Common Pitfalls in CDSCO SaMD License Application
In India, Central Drugs Standard Control Organization (CDSCO) stringently regulates Software as a Medical Device (SaMD). Therefore, securing the CDSCO SaMD license is a mandatory requirement for marketing your product in India. Owing to its increased...
Guide to Prepare CDSCO Risk Management File for SaMD in 2026
CDSCO risk management file for SaMD is a structured documentation covering hazards, risk evaluation, controls, verification, and lifecycle oversight. It aligns with ISO 14971 and IEC 62304. Moreover, CDSCO SaMD risk management file also focuses on cybersecurity,...
12 Essential Documents for CDSCO SaMD License Application
Software as a Medical Devices are regulated in India by the CDSCO. Hence, you need to mandatorily obtain the CDSCO SaMD license to market your product in India. To obtain a CDSCO license for Software as a Medical Device (SaMD), applicants must prepare a structured set...