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Clinical Evidence Requirements

Role of clinical evidence in Singapore registration​

Clinical evidence supports the conclusion that a medical device is safe and performs as intended for its claimed intended purpose. The requirement for clinical evidence and its depth varies by device class and evaluation route.

What counts as clinical evidence​

HSA accepts a range of clinical evidence types:

  • Clinical investigations (trials) conducted specifically for the device;
  • Published literature on equivalent or similar devices;
  • Post-market clinical follow-up data;
  • Clinical data from overseas regulatory submissions (e.g. the FDA's Summary of Safety and Effectiveness Data, or a CE clinical evaluation report);
  • Real-world evidence and registry data.

Clinical evidence by route​

Full evaluation: Clinical evidence is always required. The depth and scope depend on the device class and risk level. HSA will assess whether the evidence is sufficient to support the claimed intended purpose.

Abridged evaluation: The reference agency's assessment provides some confidence, but HSA still reviews clinical evidence as part of its evaluation. The level of scrutiny is reduced compared to Full.

Expedited and Immediate routes: Reduced clinical evidence requirements — the overseas approvals and marketing history provide the primary assurance. Summary clinical data and labelling from the reference jurisdiction are typically required.

Using overseas clinical data​

Clinical data generated outside Singapore is acceptable provided:

  • The patient population studied is relevant to the intended Singapore patient population;
  • The device tested is the same as the device being registered in Singapore;
  • The study design, conduct, and data quality meet applicable standards.

Clinical trials in Singapore​

Devices that require clinical evidence that can only be generated in Singapore (e.g. where overseas data is insufficient or the device is novel) may need to conduct a clinical trial under HSA's medical device clinical trial framework. See HSA: Clinical trials for medical devices.

Official sources​