New regulation on Supervision of Medical Devices was promulgated

2021. 3. 26

New regulation on Supervision of Medical Devices was promulgated

Premier Minister of the State Council Li Keqiang recently signed an order of the State Council, promulgating the Regulations on Supervision and Administration of Medical Devices (hereinafter referred to as the “Regulations”), which would be implemented on June 1, 2021. There are all 107 articles in the Regulations, including general provisions, registration and filing-record of medical devices, production of medical devices, operation and use of medical devices, handling of adverse events and recall of medical devices, supervision and inspection, legal liability and supplementary provisions.            

Meanwhile, the comprehensive department of the National Medical Products Administration issued the Notice on the Establishment of the Publicity Group of the Regulations on Supervision and Administration of Medical Devices on March 19 and decided to set up a publicity group to strengthen the study, publicity and implementation of the Regulations.
 
Source: People's Daily, Ministry of Justice, Gov.cn

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