CFDA New Clinical Data Requirements for Foreign medical devices

CFDA has proposed changes to Order 650 that would exempt additional types of Class II and III medical devices and IVDs from clinical trial requirements, and allow greater acceptance of clinical data from foreign countries in registration applications. The main changes to CFDA foreign clinical data acceptance criteria are as follows:

  • Foreign clinical trials must have been conducted according to China Good Clinical Practice (China GCP); any deviation from China GCP should be explained and justified.
  • Foreign clinical data may be used as clinical study data for devices that would undergo the clinical trial route in China, or as a verification source for substantial equivalence to a predicate device under the Clinical Evaluation Report (CER) route.
  • CFDA reviewers will focus on differences in clinical evaluation requirements (selected clinical study endpoints, for example), ethnicity (data should apply to Chinese populations) and clinical trial conditions such as intended user populations.
  • Chinese market registrants should also discuss plans to use clinical data from foreign sources with CFDA before submitting their applications to the regulator. However, no standard process for setting up pre-submission consultations with CFDA is currently in place.
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