| Objective: This paper analyzes the main situation and possible causes of the unqualified passive medical devices in China, and provide references for enterprises to strengthen production system management and improve product quality. Methods: This paper summarizes the quality status of passive medical devices in 2018-2019, summarizes the causes of disqualification, and Put forward suggestions for improvement. Results and Conclusion: The unqualified detection rate of passive medical devices in China is generally stable. The causes of the unqualified mainly lie in the lack of effective verification of product design or production process, the lack of raw material acceptance and R & D capability, the lack of factory inspection capability, and the lack of thorough understanding of standards. It is suggested that passive medical device manufacturers should increase investment in research and development, improve product design, optimize and verify production process, innovate raw materials, improve sterilization and packaging process, strengthen supplier management, strict acceptance and release inspection, and strengthen the tracking of regulations and standards.It is also suggested that the drug supervision and administration department should further guide the passive medical device manufacturers to improve. |