• Regulations for the Supervision and Administration of Medica

    Regulations for the Supervision and Administration of Medica

    2018/06/28

    Article 1 These Regulations are hereby formulated with a view to strengthening the supervision and administration of medical devices, ensuring their safety and effectiveness and protecting human health and life safety. ......More>>

  • Re-registration of import products

    Re-registration of import products

    2018/06/28

    The Name of Devices and Model, Name and Address of Manufacture must be unanimously the same as the contents carried in the documents approved by the government of the Country (Region) of Origin, and must be consistent with the contents concerned c......More>>

  • Initial registration of import products

    Initial registration of import products

    2018/06/28

    A. The Direction for the Application Form of Registration 1.All the contents filled in shall be in both Chinese and English; 2.Upon the application, the form shall be printed ; ......More>>

  • CFDA issues Special Review and Approval Procedure for Innova

    CFDA issues Special Review and Approval Procedure for Innova

    2018/06/28

    On February 7, 2014, China Food and Drug Administration (CFDA) issued the Special Review and Approval Procedure for Innovative Medical Devices (interim), which will be put into force as of March 1, 2014. The Procedure is an approval channel for innova......More>>

  • CFDA issues Special Review and Approval Procedure for Innova

    CFDA issues Special Review and Approval Procedure for Innova

    2018/06/28

    On February 7, 2014, China Food and Drug Administration (CFDA) issued the Special Review and Approval Procedure for Innovative Medical Devices (interim), which will be put into force as of March 1, 2014. The Procedure is an approval channel......More>>

  • CFDA Released the Circular on the Issuance of Guidelines for

    CFDA Released the Circular on the Issuance of Guidelines for

    2018/06/28

    In order to implement the Medical Device Supervision and Management Ordinance (State Council Decree No. 650) and the Opinion of the State Council on the reform of drug and medical device review and approval system (Guo Fa [2015] 44), and to......More>>

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