Clinical Evaluation Report
for NMPA Registration

Clinical Pathways for Medical Device Registration in China

China CER Bootcamp 101

1 comment

  1. Tracy says:

    How do I know if my device is clinically exempted in China?

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Training Videos

Clinical Evaluation Phases

China CER vs. EU MDR CER

Differences China CER EU MDR CER
Periodic update Periodical update is required but updating frequency not clear Class I: every 5 years
Class II: every 2 years
Class IIb implantable and III: annual
  • Class I
  • Class II&III listed on clinical evaluation exemption catalogue
No exemption
Clinical evaluation plan Not required Required (also includes clinical development plan)
Chinese literature search Required Not required
State of the Art Required and shall include intended clinical superiority Required and shall be supported by a literature search report
Comparison device
  • Equivalent device
  • Comparable device
  • Equivalent device
Choice of comparison device
  • Must be approved in China
  • Must be CE-marked (however, exceptions can be considered)
  • Clinical (more comparison items)
  • Technical (more comparison items)
  • Biological
  • Clinical
  • Technical
  • Biological (more stringent)
Equivalence justifications Must be robust and supported by non-clinical or clinical data Rationales would be sufficient in most cases
PMCF May required for some devices Required

CER Service Process

Make Strategies for Clinical Evaluation
Data Collection
Writing and Review
NMPA Review & Follow Up

We Can Support

  • Clinical Evaluation Strategy
  • Complete CER Writing
  • Literature Search and Review
  • NMPA Supplemental Requests
  • CER Training
  • Translation
  • Complete CRO Services
  • Overseas Clinical Data Assessment
  • Real-World Study

Our Cases


BradyKnows is leading in the clinical evaluation of cutting-edge products via innovative pathway. Examples are the World’s First integrated CT Linear Accelerator and China’s First MR-Linac.

Unmet Clinical Needs

BradyKnows is committed to the clinical evaluation of advanced medical devices to resolve the unmet clinical needs of millions of patients. Examples are implants for hearing aid and glaucoma.

High Risk Devices

BradyKnows is the expert for the clinical evaluation of Class III high risk devices. Examples are automated external defibrillator, orthopedic implants, and surgical robots.



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