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Scientific supervision promotes the healthy development of medical equipment industry

2017/12/6

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  On April 16,the Symposium on Supervision over Food and Drug Administration in Shenzhen and Regulatory Policy on Medical Devices sponsored by China Pharmaceutical News Agency and Shenzhen Drug Administration was held in Shenzhen.Nearly 100 representatives from the national food and drug regulatory system and the medical device industry conducted exchanges and discussions around the topics of medical device regulation,quality control and industrial development.

  In recent years,China's medical equipment industry has been expanding,showing a pattern of big market,big circulation and big development.According to statistics from the Ministry of Industry and Information Technology,in 2012,the total industrial output value of medical equipment enterprises above designated size in China reached 295.8 billion yuan,an increase of 27.83%over 2011.At present,the regulatory system of medical devices in our country has been continuously improved,and a relatively complete administrative supervision system at the national,provincial,municipal and county levels has been gradually formed,and technical support systems including technical review,inspection and examination,quality management system inspection and adverse event monitoring have been gradually established.The important rules and regulations and management practices covering all aspects of the development,production,operation and use of medical devices have been formulated and a regulatory system based on the"Regulations on the Supervision and Administration of Medical Devices"supplemented by 10 departmental rules and regulations and more than 200 normative documents.