Who needs to apply for a CDSCO license for medical devices?

The CDSCO (Central Drugs Standard Control Organization) license is mandatory for manufacturers, importers, and distributors of medical devices classified under risk categories in India. As per the Medical Device Rules, 2017, anyone dealing with Class A (low risk), Class B (low-moderate risk), Class C (moderate-high risk), or Class D (high risk) devices must obtain the appropriate CDSCO registration or license. This includes domestic manufacturers, Indian authorized agents of foreign manufacturers, and even hospitals or clinics that produce devices in-house. Agile Regulatory offers expert guidance to navigate the CDSCO application process and ensures full regulatory compliance for seamless approvals.