Regulations on the Supervision and Administration of Medical Devices Officially Released (attached is comparisons between the new and old regulations)

  • 2021-03-18
(Promulgated by Order No. 276 of the State Council of the People's Republic of China on January 4, 2000, revised and adopted at the 39th Executive Meeting of the State Council on February 12, 2014,
revised and adopted at the 119th Executive Meeting of the State Council on December 21, 2020 in accordance with the Decision of the State Council on Amending the Regulations on the Supervision and Administration of Medical Devices on May 4, 2017)

Chapter I     General
Chapter II    Registration and Archive of Medical Devices
Chapter III    Production of Medical Devices
Chapter IV    Operation and Use of Medical Devices
Chapter V    Addressing of Adverse Events and Recall of Medical Devices
Chapter VI    Supervision and Inspection
Chapter VII    Legal Liabilities
Chapter VIII    Supplementary Provisions
(Excerpt from: http://www.camdi.org/news/9814, to read the full text, please click the link)

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