BR and Associates

The healthcare industry in India is booming and has significantly increased the demand for medical devices. To maintain safety, efficacy, and quality , all medical devices entering the Indian market or being manufactured locally must comply with the regulatory framework established by the Central Drugs Standard Control Organization (CDSCO) . The process of CDSCO Medical Device Registration plays a crucial role in ensuring compliance and market authorization. This article provides a comprehensive overview of CDSCO registration in India , including its importance, classification of devices, registration process, and the reasons why it is mandatory for manufacturers and importers. Importance of CDSCO Medical Device Registration The CDSCO , operating under the Directorate General of Health Services and the Ministry of Health and Family Welfare, regulates the import, manufacture, sale, and distribution of medical devices in India. Main Importance of CDSCO for Medical Devices : Safety and...

  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...