Medical Device Regulation: A Model Framework
(2003; 3 pages)

The term “medical devices” covers a vast array of products from simple tongue depressors to magnetic resonance equipment. The intended primary mode of action of a medical device on the human body, in contrast with that of medical products, is not metabolic, immunological or pharmacological although it may be assisted in its function by such means. With around one and a half million different devices available, it is one of the fastest growing markets today. As a consequence, the regulatory approval and licensing of medical devices is becoming more and more challenging. Ensuring the availability of quality medicines and health care products begins with effective management at national level. National medicines regulatory authorities operate with varying success in many countries and aim to achieve effective regulation of medicines. The responsibilities of regulatory authorities are broad and activities may include licensing and control of manufacture, import, export, sale, distribution, promotion and advertising; supervision and control of clinical trials; assessing safety, efficacy and quality; conducting post-marketing surveillance and monitoring adverse events; inspecting manufacturers, importers, wholesalers and dispensers at regular intervals, and providing unbiased information to professionals and the public.
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