COMPARISION OF MEDICAL DEVICE APPROVAL REGULATIONS IN U.S AND EUROPE COUNTRIES

Prathyusha B
Department of Pharmaceutics and Drug Regulatory Affairs, Krishna Teja Pharmacy College, Chadalawada Nagar, Tirupati– 517501, Andhra Pradesh, India.
Alagusundaram M
Department of Pharmaceutics and Drug Regulatory Affairs, Krishna Teja Pharmacy College, Chadalawada Nagar, Tirupati– 517501, Andhra Pradesh, India.
Jayachadra Reddy P
Department of Pharmaceutics and Drug Regulatory Affairs, Krishna Teja Pharmacy College, Chadalawada Nagar, Tirupati– 517501, Andhra Pradesh, India.

EMEA ,Quality management systems ,Filing of medical device license application ,Regulation of medical devices ,

The knowledge and compliance with regulatory requirements is a key to success in development and marketing of medical devices. As the use of medical devices has increased, stringent regulatory standards are required to ensure safety, efficacy and performance of medical devices with least adverse effects. Recently introd uced guidelines help to provide adequate guidance for effective registration by competent authorities, manufacturers and importers. The U.S medical devices regulatory framework is based on FDA‟s Center for Devices and Radiological Health (CDRH) is responsi ble for regulating and in EUROPE „The European Medicines Agency (EMEA)‟ is a decentralized body of the European Union (EU) responsible for medical device regulations. The present article overviews the detailed regulation framework for registration of medical devices in U.S and EUROPE.

5 , 2 , 2015