CDSCO Medical Device Registration in India – A Complete Guide
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...