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The device audit center of the State Food and Drug Administration publicly solicited opinions on the proposed new and revised catalogue of medical devices exempted from clinical evaluation (2022 exposure draft)

A few days ago, the official website of the medical device technical evaluation center of the State Drug Administration issued a notice to publicly solicit opinions on the proposed new and revised catalogue of medical devices exempted from clinical evaluation (2022 exposure draft). The original text is as follows:

All relevant units:

In order to implement the opinions of the general office of the Central Committee and the general office of the State Council on deepening the reform of the evaluation and approval system and encouraging the innovation of drugs and medical devices (office Zi [2017] No. 42), further standardize the clinical evaluation of medical devices, and expand the scope of the catalogue of medical devices exempted from clinical evaluation and the catalogue of in vitro diagnostic reagents exempted from clinical trials (hereinafter collectively referred to as the exemption catalogue), Our center has initiated the preparation and revision of the 2022 exemption catalogue.

On the basis of the preliminary work, our center has formed the”recommended new and revised list of medical devices exempted from clinical evaluation (2022 draft for comments)” (see Annex 1), which will be open for comments on the center’s website from now on. At the same time, all relevant units are also invited to put forward suggestions on the addition and revision of the exemption catalogue issued in 2021. For relevant comments or suggestions, please fill in the feedback form (see Annexes 2 and 3) and send it to the email address before August 8, 2022:[email protected] 。 When sending an email, please indicate”feedback on 2022 exemption catalogue” at the subject of the email.

Attachment:1It is suggested to add and revise the catalogue of medical devices exempted from clinical evaluation (2022 exposure draft) xlsx(download)

          2.Exemption list feedback form -md.xlsx(download)

          3.Exemption list feedback form -ivd xlsx(download)

State Drug Administration

Medical device technical evaluation center

July 5th, 2022