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Regulatory Guide - Medical Devices - Re-registration of import products
Re-registration of import products
 
2011/7/4 9:21:24¡¡Source: ¡¡Hits:

1. The Direction for the Application Form for Registration
     1) All the contents shall be in both Chinese and English£»
     2) All  the contents must be printed£»
     3) All  the items must be completely filled in, and as for the vacant items, ¡°/¡± shall 
        be  used to show inapplicability£»
     4) 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 carried in the test reports, operation instructions of the
        product, and so on; 
     5) Any enterprise shall not set up the format for the Application Form for 
        Registration without authorization. The Application Form may be downloaded from
        the website:  http://www.sda.gov.cn/ylqjzc/setup.exe
    2.  As for the medical devices products manufactured by enterprises abroad, they 
        shall be re-registered 6 months prior to the date of expiry of the registration
        certificates. Upon the application for re-registration, the following materials shall
        be submitted: 
     1) The qualification certificate of the Applicant.
     2)  Copy of the original registration certificate.
     3) The certificate recognized by the government of the Country (Region) of Origin to
        authorize the products as medical devices to enter into the market of the
        country.
     4) Technical Standards of Products: Requirements of Safety and Technical
        Performance of Products, and the corresponding experimental measures (the
        standards of the products to be registered).
     5) Operation manual of Products.
     6) Type test Reports issued by the Medical Devices Quality Detection Agency
        authorized by the State Drug Administration within the recent one year£¨applied
        to Products of Class II and Class III£©.
     7) Product Quality Follow-up Reports.
        The Product Quality Follow-UP Reports presented by the Manufacturer or after-
        sale service agency after the application in the medical units of China.
     8) The Product Quality Guaranty presented by the Manufacturer, to guarantee that
       the quality of the products registered and sold in China are unanimously the
       same  as that of the identical products put into market in the Country (Region) of
       Origin.
     9) The certificate of commission for the After-Sale Service Agency designated in
       China, the letter of commitment and business certificate of the commissioned
       agency.
     10) The Self-Guarantee Declaration on the authenticity of the materials submitted.
        Note: The requirements for the documents listed in Items (1), (3), (4), (5), (6), (8), (9),
       (10) shall be consistent with those carried in ¡°the Initial Registration of Import   Products¡±.


 

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