FAQs on medical devices registration in China are avaliable - Regulatory News - Medical Devices

We put out frequently asked questions on medical device registration in China here, which give answers to usually confused points. The questions listed as below:

Q1. Is the product a medical device?
Q2. How to classify your medical device product?
Q3. Can medical device trading company apply for the registration certificate from CFDA?
Q4. How to find the appropriate legal representative in China?
Q5. What is the registration type?
Q6. What is the practical operation to register your product in China?
Q7. What is the registration process and timeline for medical device registration in China?
Q8. What is the data requirement for medical device registration?
Q9. What are the post-registration obligations for the applicant after approval of medical device registration certificate?
Q10. How to skip or reduce the clinical trial mandate?

Please click here to have a look on details, and please feel free to let us know if you have any other questions.

May these answers make sense for you.

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