Medical Devices Rules may introduce fee and documentation requirements for post-marketing clinical investigations

The Drugs Technical Advisory Board has recommended to formally require applications for post-marketing clinical investigations to be submitted in Form MD-22, accompanied by the prescribed fee and information specified in the Seventh Schedule. The proposal also recommends a INR 1 lakh fee for permission to conduct such investigations. The amendment would provide a defined regulatory and fee framework for post-marketing clinical investigations of medical devices.