Comprehensive Study on Medical Device Regulation in India, Japan and Europe

Abstract

All devices carry a certain degree of risk and could cause problems in specific circumstances. Several medical device issues cannot be detected until extensive market experience is gained. As an example, an implantable device could fail in a manner that was not predictable at the time of implantation; the failure may reflect conditions unique to certain patients. For alternative devices, part failure can also be unpredictable or random. This current approach to device safety is to estimate the potential of a device changing into a hazard that could result in safety problems and harm. This estimate is commonly referred to as the risk assessment. The regulatory authority of various countries has their own standards for approval or disapproval of medical devices.