Abstract

COMPARATIVE STUDY OF MARKETING AUTHORIZATION PROCEDURE FOR MEDICAL DEVICES IN USA, EU AND JAPAN

Arpana Rana*, Medhavi Deshwal and Shivali Rahi

ABSTRACT

The medical device industry is one amongst the robust economic drivers worldwide. Medical devices contribute to the attainment of the highest standards of health of people. Without medical devices, routine medical procedures like bandaging a sprained gliding joint to diagnosing various diseases, implanting an artificial hip or any surgical intervention would not been attainable. Medical devices are employed in many diverse settings even by lay persons at home, by paramedical staff and clinicians, by opticians, dentists and extremely trained healthcare professionals in advanced medical facilities. Today there are an estimated 500,000 different kinds of medical devices. Every medical device is different and the regulatory strategies are one of the most challenging aspects of launching a device. Every major market like USA, Europe and Japan has its own set of regulatory requirements. More research is needed to understand the urgent need to harmonize national standards in order to minimize regulatory barriers, facilitate trade and improve access to new technologies.

Keywords: Marketing authorization; Medical device; Regulatory framework; Global Harmonization Task force; Post marketing surveillance; Comparison; Pre-market approval.