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Drug Administration on the release of medical devices exempt from clinical trials catalog

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Jan 14,2023

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Notice of the Drug Administration on the release of the directory of medical devices exempt from clinical trials (second batch of revisions)

In September 2018, China Drug Administration issued a "Notice on the publication of a new revised directory of medical devices exempt from conducting clinical trials" (No. 94 of 2018), the medical devices (and in vitro diagnostic reagents) issued earlier exempt from conducting clinical trials directory has been comprehensively revised and summarized, respectively, issued a revised summary of the "directory of medical devices exempt from conducting clinical trials" and "the Exempt from clinical trials of in vitro diagnostic reagents directory". On this basis, in December 2019, China Drug Administration issued a "Notice on the publication of the new and revised directory of medical devices exempt from clinical trials" (No. 91 of 2019), announced a number of new and revised medical devices (and in vitro diagnostic reagents) exempt from clinical trials directory.

To implement the General Office of the CPC Central Committee, the General Office of the State Council "on deepening the review and approval system reform to encourage innovation in drugs and medical devices" and the State Council to deepen the "management and service" reform requirements, to further improve the management of medical device registration, according to the "supervision and management of medical devices regulations" "medical device registration management methods In vitro diagnostic reagent registration management approach", China Drug Administration organization added and revised the second batch of medical devices (and in vitro diagnostic reagents) exempt from clinical trials directory. Now be announced, effective from the date of publication.

Notice is hereby given.

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