China SFDA Approval, Registration for Medical Device, and SFDA Registration Agent Services.
Wellkang Group
CE Marking Service
CCC Mark Service
List of Our Clients
About Wellkang
Contact Us Now!
100% Satisfication

CE-marking.com - click now to get your FREE CE marking guide!

WEEEregistration.com - click to get your FREE guide on WEEE registration now!

CCC-mark.com - get free CCC mark guide now!

we accept Visa, MasterCard, Eurocard, DinersClub, AmericanExpress, JCB, etc

 Home | Medical Device | Imported Products | Drug Law |

Criteria for medical devices classification
>> Provisions for medical device classification
>> Re-registration of imported medical devices in China
>> Initial registration of imported medical devices in China
>> Regulations for the supervision and administration of medical devices

As of 21 March 2010, a Single EU/EC European Authorised/Authorized Representative must be designated by a non-EU manufacturer of medical devices as required by directive 2007/47/EC, are you ready?
Register/Notify your MD-Medical Devices & IVD-In Vitro Diagnostic Medical Devices with MHRA & other EU/EFTA authorities by world-leading CE Marking Specialists based in London/UK. Click to get FREE Guide Now!

Re-registration of import products

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.

    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



     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



    9)        The certificate of commission for the After-Sale Service Agency designated in 

           China, the letter of commitment and business certificate of the commissioned 



   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”.

(Source: SFDA)

 Home | About Us | Contact Us | Copyright | Privacy Policy | Order Now |