Regulatory requirements for compilation of dossier and registration of aNDA for parenterals in USA

2^nd International Conference and Exhibition on Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

G.V.N.S. Krishna Chaitanya, M.P.Venkatesh, T.M. Pramod Kumar and Hari Kishan. K

Posters: Pharmaceut Reg Affairs

Abstract :

The term medical devices cover a vast range of equipment, from simple tongue depressors to haemodialysis machines. Like medicines and other health technologies, they are essential for patient care. In the light of escalating use of medical devices, stringent regulatory standards are required to ensure that the devices are safe, well studied and have least adverse reactions. Recently introduced guidelines and the amendment in the law will provide adequate guidance for both the manufacturers and competent authorities to manage cases efficiently and appropriately. A defective device may result in inaccurate patient results leading to misdiagnosis, delays in treatment, adverse events, injuries, or even death. Therefore, a thorough review of the medical device prior to being released for use by the public and effective monitoring of the medical device once placed on the market is crucial. This paper presents the regulatory requirements for medical devices in United States, European Union and Canada and also compares the regulatory requirements for the registration of the medical devices for the three countries.

Biography :

G.V.N.S. Krishna Chaitanya has completed his Bachelors in Pharmacy from JSS College of Pharmacy, Mysore. After that entered in to Sales and Marketing and was Associated with Wockhardt Health care for four months and then to Abbott Health Care in critical cardiac division as Territory Business Manager for Eight Months and Joined in Masters in Pharmacy In JSS College of Pharmacy, Mysore in Regulatory affairs group. He has attended many conferences, Presented Posters and published few Review articles in Journals.