Notice on Issuing the Administrative Measures for the Monitoring and Re-evaluation of Adverse Events of Medical Devices (for Trial Implementation)
Release time:
2018-08-08
Notice on Issuing the Administrative Measures for the Monitoring and Re-evaluation of Adverse Events of Medical Devices (for Trial Implementation)
Guo Shi Yao Jian Xie [2008] No. 766
The Food and Drug Administration (Drug Administration) and Health Department of all provinces, autonomous regions and municipalities directly under the Central Government, the Health Bureau of Xinjiang production and Construction Corps, the China Institute for the Control of Pharmaceutical and Biological products, the Drug Evaluation Center of the State Food and Drug Administration, the Technical Evaluation Center of Medical Devices, and the Drug Certification Management Center:
In order to strengthen the monitoring and re-evaluation of adverse events of medical devices, according to the Regulations on the Supervision and Administration of Medical Devices, the Ministry of Health and the State Food and Drug Administration have formulated the Administrative Measures for the Monitoring and Re-evaluation of Adverse Events of Medical Devices (for Trial Implementation), which are hereby issued to you for your careful implementation.
State Food and Drug Administration the People's Republic of China Ministry of Health
December 29, 2008
Measures for the Administration of Monitoring and Re-evaluation of Adverse Events of Medical Devices (for Trial Implementation)
http://www.sda.gov.cn/WS01/CL0059/34994.html
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