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Imported Medical Device
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  • What are medical devices?

  • Which authority is responsible for the filing/registration of MDs?

  • What is the validity of filing/registration certificates?

  • What are the necessary data the distributor of a medical device must have?

  • What are technical specifications of a medical device?

Clinical Trial

For the filing of class I MDs, clinical trial is not required. For the registration of class II and III MDs, clinical trials should be conducted.

For some products clinical trial is exempted, as listed in:
CFDA circular about the directory of class II MDs exempted from clinical trial (No. 12, 2014)
CFDA circular about registration approving work standard of domestic class III MDs and imported MDs.

For more information about clinical trials, please see Clinical Trials.

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QUICK LINKS

  • CFDA
  • CFDA MD Evaluation Center
  • PKU MD Testing Center
  • BJ Institute of MD Testing
  • National Institute for F&D Control

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