Post Marketing Surveillance Requirements of Drug and Medical Devices Stents

Abstract

This research article, titled "Post Marketing Surveillance Requirements of Drug and Medical Devices Stents" provides a comprehensive overview of the post marketing surveillance of drug eluting stents in India and European Union (EU). The drug eluting stents are used for the treatment of coronary angioplasty Drug eluting stents can significantly reduce the rate of restenosis by 60-75% as compare to bare metal stents. New technologies are often introduced into the market without proper safety and effectiveness data. To know about the safety and effectiveness of the drug eluting stents after marketing, Post marketing surveillance plays a vital role it includes Periodic Safety Update Report (PSUR) and Post Marketing Clinical Follow Up Studies (PMCF) for the identification of residual risk during the process and also explained about the functions of manufacturer and notified bodies, regulatory requirements of drug eluting stents in India and European market.