Background and Aim: From this new crown pneumonia epidemic, it can be found that the existing system is still unable to meet the needs of emergencies such as public health. It is necessary to do a good job of system reserves for the accessibility of drugs and medical devices from the level of laws and regulations. This needs to be sorted out to achieve accessibility. The existing regulations and systems should be improved to meet the needs of medical device use in public health and other emergencies. However, medical devices cannot fully meet clinical needs due to factors such as long research and development and inspection cycles, wide applicable standards, insufficient production capacity, and cumbersome review processes. In public health emergencies, medical devices that serve as auxiliary or direct treatment play a crucial role and play an indispensable role. Therefore, whether medical devices can function safely and effectively has become a determining principle. By conducting procedural testing on a specific medical device in public health emergencies in 2022, the qualification status of such medical devices can be more clearly and intuitively analyzed, And the specific problems with unqualified medical devices, and these medical devices during this period based on the obtained data. Materials and Methods: Safety testing of medical devices used in 8 public health events using Chinese national standards Results: 87% of the samples meet national standards and pass the inspection Conclusion: Laws and regulations need to be improved, there are hidden dangers in regulation, the ability of regulatory teams needs to be improved, medical device enterprises have problems, medical devices should strictly follow national standards, and the public should actively participate in medical device regulation
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Ziyue Sheng (2024) studied this question.
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