How to register an IVD medical device with CDSCO?
October 18, 2024 ⚊ 1 Min read ⚊ Views 12 ⚊ HEALTH
To register an IVD medical device with CDSCO, applicants must submit a completed Form MD-14 along with required documents, including device master files, performance evaluation reports, and labeling details. The application must also include information on the device’s safety and effectiveness, as well as compliance with ISO standards. CDSCO reviews the submission for conformity with Medical Device Rules, 2017. Upon successful evaluation, the registration certificate is issued in Form MD-15. Applicants must also pay the prescribed fees and ensure ongoing compliance with regulatory standards.
Read details: https://www.dueranconsultancy.com/in-vitro-diagnostics
Tags: drugs, health
