• Final approval is granted to the foreign manufacturer.
• Import license will have the Medical Device Registration Record as the attachment and include the following information:

          - Manufacturer's name, address.

          - Address of actual manufacturing site(such as OEM site)

          - Name of the device (English/Chinese).

          - Model information of the device (English/Chinese).

          - Name and code of approved Chinese product standard.

          - Product structure, components, accessories, key performance parameters.

          - Indications/Intended use.

          - Name of the registration agent.

          - Name of the after sales service agent      

• Company information must be consistent:

         - Company address, manufacturer plant address, OEM plant address.

         - Consistent in original approval (i.e. CE/FDA 510(K)/CFG), authorization letters and SFDA

           application forms.

         - Change in the manufacturing plant address will be considered a new registration.

         - Any inconsistency and the submission dossier will be rejected.

• Product information must be consistent:

        - Product name / brand name, models, product code, accessories.

        - Consistent in original approval (i.e. CE/FDA 510(K)/CFG), authorization letters and SFDA

          application forms.

        - Adding models or accessories only can only be done during a renewed registration or it will

          be considered as a new registration.

• Sample testing for registration is a full type testing:

       - Testing items include performance items and safety items (i.e. biocompatibility test, electrical

          safety test etc.).

       -Testing is based on the Chinese standards and product specifications drafted by the

         registration agent in China.

       -If after submission, SFDA reviewer feels more performance or safety requirements need to be

        added in the Chinese product standard, testing on these items need to be supplemented.

• Testing center selection is also very important:

       - There are 10 major SFDA authorized test labs in China each with a different scope of testing.

       - Selecting the wrong test site can lead to an SFDA rejection of the test report.

       - For Products with a new technology which may not be listed in any scope of a test lab, we 

         strongly suggest client apply to the SFDA before conducting the testing.

       - The application could take 3~6 months. An applicant can combine this application with

         a classification application, and send to the SFDA at the very beginning of the registration

         process.

• Chinese Product Standard drafting is the most important part of the registration:

       - Because it is not reviewed by the CMDE before testing and sample testing is done

         on the company's draft standard.

       - If the standard is deemed unsatisfactory, the CMDE/SFDA may request the company to

         revise the specifications and re-test -- that means the company has to spend extra time

         and money.

       - Also, the SFDA will use product standard to determine if different models can be registered

         under one application.

• Foreign company must provide sufficient information to support the drafting of Chinese specification by the registration agent:

       - Detailed information on product shape, appearance, and exact dimensions should be

         provided.

       - Additional information on the structure of the device may also be required, such as circuit

         diagrams, etc.

       - Detailed specifications of technical parameters, including name, range, limits, relevant testing

         methods, and a full performance test report.

       - Quality control documents for finished products, such as SOPs are also required.

• Foreign company must provide sufficient information to support the drafting of Chinese specification by the registration agent:

        - For any standards / requirements mentioned, please provide a full report:

        - General requirements for electronic safety (IEC 60601-1/ IEC61010-1).

        - Biocompatibility (ISO 10993).

        - Sterility test report.

        - Stability testing report or shelf-life determination testing report.

• For implant products, technical information on raw materials should also be provided.