Home> Laws and Regulations

  • Rules for Unique Device Identification System

    2022-06-30

    The Rules are hereby formulated in accordance with the Regulations on Supervision and Administration of Medical Devices, so as to regulate the establishment of unique device identification system (UDI system) and strengthen the whole-life cycle management of medical devices.

  • Provisions for the Lot Release of Biological Products

    2022-06-30

    Provisions for the Lot Release of Biological Products, deliberated and adopted at the 11th executive meeting in 2020 of State Administration for Market Regulation on November 19, 2020, is hereby promulgated and shall go into effect as of March 1, 2021.

  • Provisions for the Supervision and Administration of Drug Manufacturing

    2022-06-30

    The Provisions for the Supervision and Administration of Drug Manufacturing, adopted at the first executive meeting of the State Administration for Market Regulation in 2020 held on January 15, 2020, is hereby promulgated and shall come into effect as of July 1, 2020.

  • Provisions for Drug Registration

    2022-06-30

    The Provisions for Drug Registration, adopted at the first executive meeting of the State Administration for Market Regulation on January 15, 2020, is hereby promulgated and shall come into force as of July 1, 2020.

  • Provisions for Crude Drugs Importation

    2022-06-30

    The Provisions are applicable to the application, approval, filing, port testing as well as supervision and administration of crude drugs importation

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