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NMPA Announcement on Issuing the Catalogue of Medical Devices Exempt from Clinical Trials (Revised Second Batch)

2021-03-10 15:42:52 147

   In September 2018, NMPA issued the Announcement on the Issuance of the Newly Revised Catalogue of Medical Devices Exempt from Clinical Trials, which comprehensively revised and summarized the previously published Catalog of medical devices (and in vitro diagnostic reagents) exempt from clinical trials. Consequently, the revised and summarized Catalogue of Medical Devices Exempt from Clinical Trials and Catalogue of In Vitro Diagnostic Reagents Exempt from Clinical Trials were issued respectively. On this basis, in December 2019, NMPA issued the Announcement on the Issuance of the New and Revised Catalogues of Medical Devices Exempt from Clinical Trials, and published the first batch of New and Revised Catalogues of Medical Devices (and in vitro diagnostic reagents) Exempt from Clinical Trials.

  In order to implement the Opinions on Deepening the Reform of Review and Approval System and Encouraging the Innovation of Drugs and Medical Devices issued by the General Office of the Central Committee of the Communist Party of China and the General Office of the State Council and the requirements of the State Council for deepening the reform of "streamline administration, delegate power, strengthen regulation and improve services", in accordance with the Regulations for the Supervision and Administration of Medical Devices, the Provisions for Medical Device Registration and the Provisions for In Vitro Diagnostic Reagent Registration, the NMPA organized the addition and revision of the catalogue of the second batch of medical devices (including in vitro diagnostic reagents) exempted from clinical trials. It is promulgated and implemented as of January 14, 2021.

 

国家药品监督管理局2021年第3号通告附件1.doc (Medical devices)

国家药品监督管理局2021年第3号通告附件2.doc (IVD product)