China News Service, August 18th. On the 17th, the State Food and Drug Administration announced the "Letter on the Reply to the Proposal No. 04104 (Medical and Health Category No. 383) of the 13th National Committee of the Chinese People's Political Consultative Conference".
The State Food and Drug Administration stated that it will continue to strengthen the guidance on the registration of Class II medical devices, solidly promote the construction of Class II review training bases, strengthen the training of local review teams, and promote the improvement of review and approval capabilities.
In the work arrangement at the end of the year, the local drug supervision and administration departments will sort out and assess the approval of Class II medical devices throughout the year, promote the standardization of approval behavior, continue to do a good job in the supervision and guidance of the registration and review of Class II medical devices in China, and promote the second The technical review workflow of similar medical devices has been continuously improved to improve the review quality.
(Zhongxin Finance)
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