| 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. |
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