China’s Premier Li Keqiang just signed the State Council Order No. 680, announcing the Decision on Modification of “Medical Device Regulation Policy” by the State Council, effective immediately. The State Council Executive meeting suggested converting approval process of large medical equipment configuration from Non-Administrative Permit review to Administrative License approval, to further standardize and strengthen the management of large-scale medical equipment use, protection of medical quality and safety, and promote the rational allocation of medical resources.
There are 10 items in the Decision, mainly defining the legal conditions for large-scale medical equipment configuration license and departments for implementation. It is also required that large medical equipment catalog should be raised by the State Council department and submitted to the State Council for approval prior to implementation. Meanwhile, the Decision strengthened the post-license supervision and management, the provisions of the Health and Family Planning Commission in charge of monitoring and assessment of large medical equipment use; immediate corrective and legal actions should be applied once illegal uses of large medical equipment related to excessive examination or excessive treatment are identified. Corresponding legal liability would be added. The qualification management of medical equipment clinical trial institutions is to be changed from permission to filing, and exemption of medical device operating enterprises and users is to be increased.
Contact China Med Device (CMD) team if you would like to know more about CFDA’s registration process and policies or know how a policy update like this may affect your medical device’s entry to China. Please call us 978-390-4453 or email info@ChinaMedDevice.com.
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