AN OVERVIEW OF THE POST MARKETING SURVEILLANCE OF MEDICAL DEVICES

Anish Desai* and Sunaina Anand

ABSTRACT

Medical Devices are evolving at a rapid rate to meet growing healthcare demands. The success, safety and efficacy of these health tools are critical and uncompromising. In today`s regulatory set-up, approval of medical devices stands on equivalence. Proof of clinical efficacy and long term safety is not a regulatory requirement. This article highlights the regulatory challenges faced by medical device manufacturers. Furthermore, particular emphasis is given to safety monitoring through post-marketing surveillance.

Keywords: Medical Devices, Safety, Post-marketing surveillance, Regulatory, Monitoring.