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On the morning of July 10th, the 2023 National Medical Device Safety Promotion Week was launched in Beijing. The theme of this event is 'Safe Use of Equipment and Shared Health'.
Xu Jinghe, member of the Party Group and Deputy Director of the National Medical Products Administration, emphasized that in recent years, China's medical device regulatory work has made significant progress, the medical device industry has flourished, and people's health rights and interests have been better protected.
It is reported that as of now, the National Medical Products Administration has approved 217 innovative medical device products, with the annual approval number increasing from 1 to 55 by 2022. The approved products also cover many high-end medical devices such as heavy ion therapy systems, proton therapy systems, surgical robots, artificial blood vessels, etc., achieving a double harvest in both quantity and quality.
In 2022, the main operating revenue of medical devices will reach 1.3 trillion yuan, becoming the second largest market in the world. Xu Jinghe emphasized that the next step is to continue to deepen the reform of the evaluation and approval system, and constantly stimulate the vitality of high-quality development of industrial innovation; Continuously promoting the scientific research and application of medical device regulation, adding momentum to industrial innovation and development; Continuously strengthen system governance and enhance quality and safety supervision throughout the entire lifecycle of medical devices; Continuously building a shared governance pattern, strengthening the organic collaboration among the four levels of regulatory departments, and improving the overall governance and sharing pattern of enterprise responsibility, government supervision, social self-discipline, departmental collaboration, public participation, and legal protection; Continuously promote the construction of regulatory capacity, accelerate the improvement of the scientific, legal, international, and modern level of medical device regulation.
The safety of medical devices is related to the health and safety of the people, as well as the overall situation of economic development and social harmony and stability. The National Medical Products Administration has organized a special campaign to rectify drug safety and consolidate and improve drug safety throughout the system, strengthening supervision and risk prevention, enhancing capabilities to promote development, and effectively ensuring the quality and safety of medical devices.
In addition, in recent years, the National Medical Products Administration has prioritized the review and approval of high-end medical devices with core technologies that have Chinese invention patents, main working principles/mechanisms of action that are domestically innovative, significant clinical application value, and urgent clinical needs, in accordance with the 'Special Examination Procedure for Innovative Medical Devices' and 'Priority Approval Procedure for Medical Devices', allowing these products to be 'queued separately and run all the way'.
With the continuous implementation of supportive policies, China's medical device industry has developed rapidly in recent years. The number of production enterprises has exceeded 30000, the annual registered number of products is close to 45000, and the industry scale has exceeded 1 trillion yuan. The compound annual growth rate in the past five years has been 10.54%, which is higher than the overall growth level of China's manufacturing industry. The Chinese medical device market has accounted for 27.5% of the global market, becoming the second largest market for medical devices worldwide, with increasing industrial agglomeration and international competitiveness.
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