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Regulations on Medical Device Usage and Management Amended

Several amendments to the current Regulations on the Supervision and Administration of Medical Devices have been issued by the State Council. Primarily, these updates relate to the statutory permissions required for the installation of large medical equipment and the relevant departments with responsibility for their use and management.

Under the terms of these amendments, the relevant department of the State Council will compile a catalogue of large medical equipment in compliance with record filing and clinical trial management requirements. This catalogue will be adopted for formal use following approval by the State Council. Overall, the relevant department in charge of public health and family planning will be responsible for the required supervision and evaluation of such items. 

For further details (in Chinese), please refer to the following website:

Decision of the State Council on Amending the Regulations on the Supervision and Administration of Medical Devices (State Council Decree No. 680)

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