Regulation of Medical Device with Special Emphasis on its Registration Procedure and Adverse Event Reporting System in US and Australia

Author(s)

Parikh, V.H., Thula, K.C., Maheshwari, D.G.

Author's Affiliation

Abstract

A medical device is an instrument, apparatus, implant, in vitro reagent, or similar or related article that is used to diagnose, prevent, or treat disease or other conditions, and does not achieve its purposes through chemical action within or on the body. Regulation of device has also evolved due to an increasing awareness of the need for more consistent approach to regulatory documentation. The Global Cardiovascular Device industry is growing rapidly and exhibits signs that it will continue to evolve and expand to reach $97 billion by 2015. Over 80 million people suffer from cardiovascular diseases globally with more than 17 million deaths every year. Cardiovascular devices are life threatening devices and it is directly affecting the patient’s life so strict and specific regulation is requiring for high-risk medical devices. In US, Food and Drug Administration evaluates high-risk medical device such as cardiac implantable, pacemaker, and implantable cardioverter-defibrillators via the Pre-Market Approval process. In Australia, Therapeutic Goods Administration regulates the medical device under the Australian Register of Therapeutic Goods. This article discuss about the general introduction about medical device, its classification, registration procedure, documentation required for registration and adverse event reporting system of medical device in US and Australia.

Keywords

FDA, 510(k), PMA, CDRH, TGA, DEAL

Cite This Article

Parikh, V.H., Thula, K.C., Maheshwari, D.G. (2015). Regulation of Medical Device with Special Emphasis on its Registration Procedure and Adverse Event Reporting System in US and Australia, International Journal for Pharmaceutical Research Scholars (IJPRS), 4(1), 61-73.