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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.

PMCF is typically required for higher-risk devices (Class III/IV) or when clinical evidence from pre-market sources is limited.