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Announcement of the National Medical Products Administration on Issuing Measures to Optimize Whole Life-Cycle Regulation in Support of the Innovative Development of High-End Medical Devices ([2025 ]No. 63)
2025-10-14
To thoroughly implement the principles of the Third Plenary Session of the 20th CPC Central Committee and the requirements of the Opinions of the General Office of the State Council on Comprehensively Deepening the Reform of Regulation of Drugs and Medical Devices to Promote the High-Quality Development of the Pharmaceutical Industry (GBF [2024] No. 53), and to improve the review and approval mechanisms, strengthen whole life-cycle regulation, fully support major innovations in high-end medical devices, promote the application of more new technologies, new materials, new processes, and new methods in the healthcare field, better meet public health needs, and enhance China's international competitiveness in high-end medical devices, the National Medical Products Administration hereby proposes the following supporting measures.
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Policy Interpretation of the Quality Management Specifications for Online Sales of Medical Devices
2025-07-21
With the rapid development of e-commerce, the online medical device sales market in China has experienced explosive growth in recent years. According to statistics, from 2018 to the present, the number of medical device distributors engaged in online sales has increased from 8,717 to over 360,000, while the number of third-party platform enterprises has grown from 77 to 851.
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NMPA Announcement on Further Improvement and Optimization of Matters Concerning the Production of Imported Medical Devices in Domestic Enterprises in China (No. 30, 2025)
2025-06-11
To thoroughly implement the decisions of the CPC Central Committee and the State Council on advancing high-level opening-up, fully carry out the requirements of the Opinions of the General Office of the State Council on Comprehensively Deepening the Regulatory Reform of Drugs and Medical Devices to Promote the High-Quality Development of the Pharmaceutical Industry (GBF [2024] No. 53), continuously deepen the reform of medical device regulation, and promote the high-quality development of the medical device industry, the following adjustments and optimizations are hereby made to certain provisions of the Announcement.
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Transcatheter Mitral Valve Clip System Approved for Marketing
2025-06-11
Recently, the innovative product Transcatheter Mitral Valve Clip System of Hangzhou Dawneo Medical Technology Co., Ltd. is approved by China NMPA.
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Aortic Covered Stent System Approved for Marketing
2025-06-11
Recently, the innovative product "Aortic Covered Stent System" of Lifetech Scientific (Shenzhen) Co., Ltd. is approved by China NMPA.
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Interpretation of the NMPA Announcement on Further Adjustment and Optimization of Matters Concerning the Production of Imported Medical Devices in Domestic Enterprises in China
2025-06-11
The NMPA Announcement on Further Adjustment and Optimization of Matters Concerning the Production of Imported Medical Devices in Domestic Enterprises in China (No. 30, 2025) was issued on March 18, 2025.
