Enlightenment on Carrying out Reporting Responsibility of Manufactures in China from Reviewing Medical Device Reporting Practice in US / 中国医疗器械杂志
Chinese Journal of Medical Instrumentation
;
(6): 545-548, 2020.
Article
in Chinese
| WPRIM
| ID: wpr-880408
ABSTRACT
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.@*CONCLUSIONS@#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.
Full text:
Available
Index:
WPRIM (Western Pacific)
Main subject:
Product Surveillance, Postmarketing
/
China
/
Equipment and Supplies
Country/Region as subject:
Asia
Language:
Chinese
Journal:
Chinese Journal of Medical Instrumentation
Year:
2020
Type:
Article
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