Enlightenment on Carrying out Reporting Responsibility of Manufactures in China from Reviewing Medical Device Reporting Practice in US

Objective By introducing the Medical Device Reporting (MDR) system and related inspection practice of the US, this paper puts forward some suggestions on implementing reporting responsibility of manufactures in China. Methods The MDR system and the related inspection system in the US were systematically analyzed. Results The US had established a sound system for discovering and reporting MDR, and a mechanism for inspecting the implementing of manufactures, forming an effective post-market surveillance system. Conclusion By learning from the experience of the US, we can carry out the post-market surveillance of medical devices adverse events in China from the aspects of implementing the existing system, strengthening the reporting ability and perfecting the inspection mechanism.