State Drug Administration "Medical Device Adverse Event Monitoring and Reevaluation management Measures (Draft Amendment)" (draft for comment) notice of public solicitation of comments
2021-12-25 16:32
In order to implement the Regulations on the Supervision and Administration of Medical Devices (Decree No. 739 of The State Council) and further standardize the management of adverse event monitoring and reevaluation of medical devices, we have drafted the Measures for the Management of Adverse Event Monitoring and Reevaluation of Medical Devices (Draft Amendment) (Draft for comments), which is now open to the public for comments. The public can provide feedback in the following ways and means:
1. Log on department of justice of the People's Republic of China, the Chinese government legal information network (http://www.moj.gov.cn, http://www.chinalaw.gov.cn), enter the main menu of "legislative comment" on the homepage.
2. Email qxjgsjcc@163.com. When sending an email, please indicate "Medical Device Adverse Event Monitoring and reevaluation Management Measures (Draft amendments)" in the subject line of the email.
3. Address: Department of Medical Device Supervision and Administration, National Medical Products Administration (No. 1, North Lu Yuan, Exhibition Road, Xicheng District, Beijing), postcode 100037, and please indicate "Administrative Measures for Monitoring and Reevaluation of Medical device Adverse Events (Draft Amendment)" on the envelope.
The deadline for feedback is December 22, 2021.
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