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Clinical Evidence Requirements

TR-008 · Clinical evaluation

General Medical Devices​

All devices must have clinical evidence demonstrating safe and intended performance in clinical practice. Sources include:

  • Clinical investigations of the subject device
  • Equivalent device data with justified equivalence
  • Published clinical literature
  • Post-market clinical follow-up (PMCF) data

For Class III/IV, a formal Clinical Evaluation Report (CER) using a systematic review methodology is expected. For Class II, a clinical evidence summary may suffice.

IVDs — Performance Evaluation​

IVDs require performance evaluation rather than a CER:

  • Analytical performance — sensitivity, specificity, precision, accuracy, limits of detection
  • Clinical performance — sensitivity/specificity against a reference method/gold standard
  • Stability data — shelf life and transport conditions

Overseas Clinical Data​

The MDD accepts clinical data generated outside Hong Kong, provided the study population is reasonably representative of HK patients and the device is identical or equivalent to the one submitted.