CDSCO registration for SaMD in India is mandatory for all Software as a Medical Device products under the Medical Devices Rules (IMDR) 2017. SaMD is classified into Class A (low risk), B (low-moderate), C (moderate-high), and D (high risk). The registration process requires filing with the Central Drugs Standard Control [...]
CDSCO registration for dental medical devices is mandatory under India’s Medical Device Rules (MDR), 2017. All dental devices — from basic instruments to complex implants — must be licensed before manufacture, import, or sale in India. CDSCO classifies dental devices into Class A (low risk), Class B (low-moderate risk), Class [...]
To legally manufacture or import sunscreen in India in 2026, you need a cosmetic license under the Drugs and Cosmetics Act, 1940. Importers must apply using Form COS-1 and receive Form COS-2 (import license) from CDSCO. Manufacturers must apply using Form COS-5 and receive Form COS-8 (manufacturing license) from the [...]
