1. Why classification is different between original country and China?  [Answer]

    2. Where I should register my product?  [Answer]

    3. What is definition of medical device in China?  [Answer]

    4. What are the key regulations for medical device registration in China?  [Answer]

    5. What are the meanings of the different SFDA registration types?  [Answer]

    6. What is registration process and estimated timeline for Class I medical device registration?  [Answer]

    7. What is registration process and estimated timeline for Class II and III medical device registration?  [Answer]

    8. How to compile Chinese product registration standard?  [Answer]

    9. What is the requirement on package insert and label?  [Answer]

    10. What kinds of products need clinical trial in China?  [Answer]

    11. Is there any special requirement on IVD reagent registration?  [Answer]

    12. What is the classification of IVD reagent?  [Answer]

    13. What is basic registration process and estimate timeline for IVD reagent?  [Answer]

    14. What kind of documents need to be prepared for IVD reagent registration?  [Answer]

    15. What kind of documents need to be prepared for medical device registration?  [Answer]