T. Kavya1, K. Sunil Kumar2
1Department of Pharmaceutics-DRA, Sun Institute of Pharmaceutical Education and Research, Kakupalli, Nellore, Andhra Pradesh, India.
2Associate Professor, Department of Pharmaceutics-DRA, Sun Institute of Pharmaceutical Education and Research, Kakupalli, Nellore, Andhra Pradesh, India
A B S T R A C T
A Medical Device is a product which is used for medical purposes in patients, in diagnosis, therapy or surgery; whereas medicinal products (also called pharmaceuticals) achieve their principal action by pharmacological, metabolic or immunologicals means. Medical devices act by other means like physical, mechanical, thermal, physico-chemical or chemical means. The market potential for medical devices is very high when compared to pharmaceuticals. The global market for medical products and hospital supplies is over$220 billion (2009). As like pharmaceuticals, medical devices too have regulatory issues during the development of the product. The four phases of development such as research, development, regulatory and post market studies play a vital role in getting a device into the market. The project mainly deals with the regulations concerning medical devices product registrations in regulated (United States, Health Canada) and emerging markets (India, Brazil & Singapore). Different levels of regulatory controls imposed on different classes of devices. The core area will be dealing with the type of submissions to health regulatory authorities, Types of approvals, crucial factors involved in classification of medical devices, Clinical trial related issues and comprehensive data for Product registrations. The project also deals with GHTF (global harmonization task force) an international body that frames guidelines for medical devices which are accepted globally. GHTF plays a major role in framing guidance documents which are accepted globally. It prevents the trade barrier and allows safe access to medical devices in different parts of the world.