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In 2019, China’s medical equipment industry continued to maintain a good momentum of development, such as production enterprises, the main revenue, R&D input, import and export trade and so on.The pharmaceutical supervisory and administrative departments throughout the country have carried out in-depth reform of the system of examination and approval of medical devices, continuously increased strict supervision over the whole life cycle of medical devices, constantly strengthened the basic construction of regulatory standards, and made new achievements in various work, which has strongly promoted the healthy and rapid development of the medical devices industry in China.
This book discusses the policy changes which affect the development of medical device industry in 2019 from many angles.In the aspect of examination and approval system reform, it is proposed to improve the standard management system of medical equipment, strengthen the capability of medical device classification management and medical device inspection; in the aspect of post-market supervision of medical devices, it is suggested to accelerate the construction of the legal system, comprehensively promote the consultation of risks, strengthen the supervision of medical device quality, etc.; it is analyzed and explained the monitoring data of bad events in 2019; it is suggested that we should actively promote the collection, analysis, analysis and examination and approval of adverse events, and control measures to reduce the products’s risk.The municipal government will take advantage of the provincial centralized procurement platform to carry out extensive volume procurement; the pilot scope of the medical device registrant system will be expanded further in 2019, and industrial innovation will be stimulated.
At the overall level of the industry, it is pointed out that the foreign trade of medical equipment in China will continue to rise in 2019, with the total import and export exceeding 50 billion US dollars, and will continue to maintain double-digit growth by 2020.The problems existing in medical equipment compliance, the construction of testing system and the quality of clinical trials are analyzed, which provide a direction for the healthy development of the industry.With medical robot, accompanying diagnosis and orthopaedic implant industry as representatives, the industry’s hot issues are clarified and their future development trend is forecasted.At the market level, this paper summarizes the market application status of medical protective materials, surgical stapler, left auricle occluder, intracranial electroencephalogram (EEG) acquisition instrument, thermal perfusion therapy of tumor body cavity, and anterior technology development of anterior segment surgical implant instrument, and gives some thoughts on its future development path.The regional level is represented by seven areas, such as Beijing, Shanghai, Guangdong, Jiangsu, Hubei, Yunnan and Inner Mongolia.The relevant data and policies on the development of medical equipment industry at the provincial level are analyzed, and the configuration of medical equipment and clinical equipment in different regions is summarized.In practice, it shows the innovative practice of promoting the healthy development of medical device industry in Shenzhen and Handan, the risk of responsibility and cognition in the actual implementation of medical device registrant system, the evaluation method of comprehensive strength of medical device industrial park, the participation mechanism of third-party organizations under the new mode of medical device CDMO, etc..
Finally, under the background of the outbreak of New Crown pneumonia, this paper discusses the guarantee system and mechanism of medical equipment supply, the guarantee system of emergency medical materials and the construction of international medical equipment supply chain, and gives some thoughts on the development of the technology application of immediate detection (POCT), the examination and approval of medical device products and the application of ECMO.