2019.10.19-22 Our company participated in the 82nd China International Medical Equipment Fair (CMEF Autumn Qingdao)
2021/11/19
2019.5.14-17 The 81st China International Medical Equipment Fair (CMEF Spring Shanghai)
2019.5.14-17 The 81st China International Medical Equipment Fair (CMEF Spring Shanghai)
2021/11/19
2018.4.11-14 Our company participated in the 79th China International Medical Equipment Fair (CMEF Spring Shanghai)
2021/11/19
2017.5.15-18 Our company participated in the 77th China International Medical Equipment Fair (CMEF Spring)
2021/11/19
2022-8-10 An overview of the scientific research and practice of medical device regulation in China
Proposed by Japanese and American scientists in the early 21st century, regulatory science has become one of the most important research fields in regulatory affairs, especially in the field of medical device regulation, which has great application potential. Medical device regulatory science is the application of regulatory science in the field of medical devices. The research on medical device regulatory science is helpful to encourage technological innovation, promote industrial development, and ensure that medical institutions can use medical devices with reasonable price, effective and safe. However, looking at the status quo of medical device regulatory scientific research in various countries and regions, few of its achievements can be systematically applied to regulatory practice, and scientific supervision is mainly based on traditional models such as expert review, format review and empirical data. The efficiency of medical device approval and the speed of industrial innovation still need to be improved. , therefore, to strengthen the regulation of medical equipment scientific research, focus on new situations and new problems in the medical field, focus on biological technology, material technology, information technology application in the field of medical apparatus and instruments, emerging technologies such as strengthen the innovative products and interdisciplinary product evaluation, review and supervision of scientific research, in a timely manner to solve the emerging technology products and regulatory issues of performance evaluation, Improve the scientific level of medical device research and development, review and production process, enhance the ability to evaluate and review the safety and effectiveness of new products, and ensure that supervision follows the pace of scientific and technological progress and industrial innovation and development. In recent years, the rapid progress of biomaterial technology, the rapid development of information and communication technologies such as Internet of things, 5G, artificial intelligence and big data, and gradually widely used in the field of medical devices, has brought great challenges to the traditional regulatory model. At the same time, the rapid development of China's medical device industry, innovative medical devices constantly emerge, the people are full of expectations for the application of advanced technology in innovative medical devices, put forward new requirements for the development of medical device supervision and scientific research. The formulation of reasonable and effective regulatory laws and regulations will directly affect the development of the medical device industry, and indirectly affect the healthy development of the entire medical industry. Specifically, national regulatory laws and regulations can help protect the market and support industrial development, but the main goal is to achieve the best medical services through safe and clinically effective medical devices. So regulators need to think about whether the latest regulations are better at achieving that goal than previous ones, and whether they can estimate how much they will deter risky devices from coming to market. In general, the scientific research on medical device supervision in China mainly comes from three aspects. First, regulatory authorities need more scientific decision-making methods and tools to support regulatory work. The lack of sufficient scientific basis for regulatory departments leads to the situation that regulatory work relies heavily on the results of expert reviews, and a limited number of expert reviews is not enough to become the whole basis for regulatory work. From another perspective, if medical equipment manufacturers use a similar, product validation method based on expert opinion (mainly based on interviews with patients or expert), may be regarded as a lack of evidence and cannot get the confirm of regulators, this is because regulators wouldn't use a limited number of expert opinion as a review of all the basis. Therefore, regulatory authorities need to have more scientific methods and tools to review and evaluate product safety and effectiveness. In recent years, regulatory research has vigorously promoted the application of data decision-making in regulatory work, and more effective data analysis methods and tools have been used to support various reviews and decisions in regulatory work. At the same time, any regulatory regulation has benefits, costs and risks. To design regulatory regulations by optimizing the ratio of benefits to risks, it is necessary to understand the interdependence of economy and technology. Without understanding these interrelationships, regulatory authorities will lack a scientific basis for decision-making, and regulatory actions may be blind. Therefore, it is a key task of regulatory science to study these interdependencie
2021/08/11
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