CDSCO License & Approval in India: Registration, Fees, Process & Documents
The Central Drugs Standard Control Organisation (CDSCO) is India’s national regulatory authority under the Ministry of Health and Family Welfare. It oversees the regulation of drugs, medical devices, in-vitro diagnostics (IVDs), cosmetics, and clinical trials. Obtaining CDSCO approval requires selecting the correct regulatory pathway based on your product type, risk classification, business activity, and manufacturing origin. 2026 CDSCO Regulatory Update: CDSCO's regulatory framework continues to evolve under the Medical Devices Rules, 2017 (MDR-2017). Recent official publications include updated risk-classification lists (including 2025/2026 classifications for Oncology, Radiotherapy, and Interventional Radiology), guidance for Medical Device Software, and updated registration frameworks for specified Class A non-sterile, non-measuring (NSNM) devices. Always verify your specific product standard against the latest CDSCO notification prior to application submission. What Is CDSCO...