China
Clinical Evaluation Report
CER
for NMPA Registration

China CER Bootcamp 101

• What is Clinical Evaluation?
  Clinical evaluation is the ongoing activities of using scientifically sound methods to evaluate and analyze clinical data to confirm the safety, clinical performance and/or effectiveness of a medical device within its scope of application.
• What are inputs of clinical evaluation?
  The input of clinical evaluation is mainly derived from clinical trial reports, clinical literature and clinical experience data.
• CER via Equivalence vs. CER via Clinical Trial Data
  If the product is developed based on existing mature technology and the intended use is unchanged, it is most likely to complete the clinical evaluation through the clinical data of equivalent medical devices. High-risk products that are based on new technologies with little or no experience, or based on existing technologies with expanded intended use, are more likely to require clinical trial data.
• What is Equivalent Device?
  The similarity between the product under application and the same kind of product in terms of the scope of application, technical and/or biological characteristics renders no significant clinical differences in the safety, clinical performance and/or effectiveness of the two, then the two products are considered to be equivalent.
• What is Comparable Device?
  When the comparison device and the product under application are not equivalent, but the two have broad similarities in the scope of application, technical and/or biological characteristics, the comparison device can be regarded as a comparable device. Clinical data from comparable devices can only be used as part of clinical evidence in CER.
• How to Choose an Equivalent Device?
  The equivalent device must have already been approved in China, has the same scope of application, the same or similar technical and biological characteristics as the subject device. It is preferred to use the manufacturer’s previous generation products or products of the same series as comparative devices.
• How to Determine the Necessity of Clinical Trials?
  The necessity of clinical trials should fully consider the scope of application of medical devices, technical characteristics, biological characteristics, risk levels, differences with existing medical devices or existing diagnosis and treatment methods, etc., if the results of non-clinical research and/or existing clinical data are insufficient to prove that the product meets the basic principles of medical device safety and performance, clinical trials may be required.
• What are the Common Questions from Reviewers for CER via Equivalence?
  • Missing comparison items
  • issing supporting info
  • Need to submit the full-text of selected publications and translated copies if not in Chinese
  • Consistency issues
• What are the Common Questions from Reviewers for CER via Clinical Trial Data?
  • Need to submit all appendices in the protocol or report
  • Ethics committee approval documents are required
  • China GCP compliance issues
  • May request CRF, summary from each study site, clinical study agreement between sponsor and investigators
  • A final CSR instead of an interim analysis report shall be submitted
  • No signatures on CSR

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