Service content of medical devices registration

1. Preparation work before registration
 a. documents assessment and sorting
 b. products classification: classify the products according to the regulation and product anticipated    
     function and make concrete registration procedure.
 C document translation: translate all the necessary documents into Chinese. The time needed will depend  
    on the amount of the documents and language classification.

2. Product specification and relevant documents compiling
The product specification should be provided before product type testing. When required by the clients, we  
will compile the product specification. It will take 1-2 weeks/ product.

3. Products type testing
We will assist you with the product type testing in the testing center correspondent to product type. There  
are ten more authorized testing center with different testing scope. Time and cost will depend on the actual
needs.

4. Clinical documents assessment and clinical trial
Some home-made and foreign products need clinical trial in China. We will help the clients to choose at least
two qualified hospitals according to the requirements of SFDA to do clinical trial. First, to make clinical
agreement and then clinical plan, and to track the course of the registration. Time and cost will depend on
the clinical agreement and statistic result of the product.

5. Product registration
90 working days according to the official regulation

6. Information feedback
Complement necessary documents, and help the clients to do the expert examining.

7. Certificate issuing and delivery
After verifying the relevant fee, we will delivery the certificate within 1 week.