• FDA Virtual Town Hall Series - Immediately in Effect Guidanc

    FDA Virtual Town Hall Series - Immediately in Effect Guidanc

    2020/05/06

    Moderator: Irene Aihie April 22, 2020 12:15 pm ET Coordinator: Welcome and thank you for standing by. At this time all parties are in a listen-only mode until the question and answer segment of todays conference at which time you may press......More>>

  • CFDA issues Special Review and Approval Procedure for Innova

    CFDA issues Special Review and Approval Procedure for Innova

    2020/04/17

    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>>

  • Re-registration of import products

    Re-registration of import products

    2020/04/17

    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>>

  • CFDA Released the Circular on the Issuance of Guidelines for

    CFDA Released the Circular on the Issuance of Guidelines for

    2020/04/17

    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>>

  • CFDA Adjusts the Administrative Examination and Approval Pro

    CFDA Adjusts the Administrative Examination and Approval Pro

    2020/04/17

    In order to implement the Opinions of the State Council on the Reform of Examination and Approval System for Medicine and Medical Devices (Guo Fa [2015] No. 44) and the reform spirit of relevant administrative examination and approval syste......More>>

  • Initial registration of import products

    Initial registration of import products

    2020/04/17

    A.TheDirectionfortheApplicationFormofRegistration 1.AllthecontentsfilledinshallbeinbothChineseandEnglish; 2.Upontheapplication,theformshallbeprinted; 3.Alltheitemsmustbecompletelyfilledin,andasforthevacantitems,ldquo;/rdquo;shallbeusedt......More>>

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