Abstract

A REVIEW ON MEDICAL DEVICE REGULATION BY VARIOUS REGULATORY AGENCIES

Rajeshvar S. Patil*, Dr. Harshal D. Mahajan, Dr. Tanvir Shaikh, Nikhil C. Chavan, Aakash A. Chaudhari and Harshada Y. Bhadane

Abstract

Today lot's of patients depends on medical device based treatment for the diagnosis and cure the several diseases. Medical Device plays an important role in healthcare by monitoring of various medical conditions. The quality and safety depends upon the regulatory guidelines. In 1992 by five members: European Union, United States, Canada, Australia and Japan invent the Global Harmonization Task Force (GHTF) to achieve regularity between the national medical device regulatory system. This study conducts a comprehensive analysis of medical device regulation by various regulatory agencies like India, European Union (EU), United States (US), Australia and Africa.

Keywords: The quality and safety depends upon the regulatory guidelines.