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To strengthen the regulation of medical devices to protect people's health

      Medical devices to as special commodities directly related to people's life and health, the main consumer markets in the world are given the high level of supervision and management requirements. Hangzhou is one of the important production and export base of China's large-scale precision medical equipment and medical electronic instruments. This report Hangzhou medical equipment's major export markets, the European Union and the United States, the two countries economies the mechanism of the implementation of legislation to regulate medical products and technical regulations system overview, a comprehensive introduction to the common technical requirements and management requirements, for Hangzhou advantage of export commodities medical electronic equipment (medical diagnostic magnetic resonance equipment, B-type ultrasonic diagnostic equipment, medical ultrasound Doppler systems, patient monitoring equipment, clinical laboratory analytical instruments, blood glucose meters and electronic sphygmomanometer, electronic thermometers, etc.) supplement the the regulations mandatory requirements of the U.S. and European markets in the environmental Protection (restriction of Hazardous Substances) and electromagnetic compatibility, as well as the various types of medical electronic equipment applicable to major domestic and international standards.

      In addition, the report on the Chinese mainland market implementation of the market access system for medical device products, systems analysis to help enterprises understand the domestic and international regulatory differences; same time, but also on the international coordination of medical device regulations and medical electrical equipment safety detection result of the global mutual recognition system (Paper No. CB system) the development status quo conducted a summarize and elaborate, with a view to the international medical devices regulatory trends and how to effectively reduce exports of medical equipment multinational market the cost and other issues for the healthcare enterprise to provide answers and help.

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