CDSCO has released the updated list of approved laboratories authorized to conduct performance evaluation of In Vitro Diagnostic (IVD) medical devices. This update, effective 29 June 2026, is important for IVD manufacturers planning regulatory submissions in India.
Learn the regulatory process, documentation requirements, CDSCO guidance, fees, and practical considerations for obtaining a Free Sale Certificate (FSC) for medical device export from India.
Understanding the CDSCO manufacturing license process is important for medical device manufacturers operating in India. This article provides a practical overview of device classification, licensing forms, documentation requirements, and key regulatory expectations under MDR 2017.
