CDSCO Medical Device Registration in India – Complete Guide
Medical devices in India are regulated by the Central Drugs Standard Control Organization (CDSCO) to ensure safety, quality, and efficacy. The CDSCO Medical Device Registration process is an obligatory step for manufacturers and importers who wish to market or sell their devices in the country. This verification mechanism ensures that each device is safe to operate and compliant with global healthcare standards and patient safety norms. Understanding the CDSCO for Medical Device Regulation The Central Drugs Standard Control Organization is the governing authority for medical device regulations under the Drugs and Cosmetics Act, 1940, framed within the Medical Devices Rules, 2017. These rules categorize devices into four risk-based classes: Class A – Low risk (e.g., Surgical dressings) Class B – Low to moderate risk (e.g., Infusion sets) Class C – Moderate to high risk (e.g., Orthopedic implants) Class D – High risk (e.g., Heart valves, Pacemakers) Each category has distinct req...