Ndct Rules

This page covers related Indian legislation applicable to medical devices.

The New Drugs and Clinical Trials Rules 2019 (ND&CT Rules) govern clinical investigation approvals from and clinical trial CDSCO for both drugs and medical devices. The Drugs (Prices Control) Order 2013 (DPCO) administered by NPPA regulates prices of certain medical devices, including coronary stents, knee implants, and other notified devices.