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Clinical Evidence

Overview​

Clinical evidence demonstrates that a medical device achieves its intended clinical performance and is safe for its intended use and user population. The depth of clinical evidence required scales with device risk class.

Class A — Clinical Evidence Not Generally Required​

For most Class A devices, clinical evidence is not required. A brief statement of intended use with supporting literature references is typically sufficient. Kemenkes may, for some Class A IVDs or devices with unusual intended uses, request basic performance data.

Class B — Literature-Based Clinical Evaluation​

Class B devices require a clinical evaluation report based primarily on:

  • Systematic literature search and review of published clinical data for the device or equivalent devices
  • Summary of clinical data demonstrating the device's safety and performance
  • Assessment of any residual clinical risks

A full clinical investigation is generally not required for Class B devices. However, Class B IVDs with patient-management implications may be subject to higher clinical evidence expectations.

Class C — Full Clinical Evaluation Report​

Class C devices require a full clinical evaluation report (CER):

  • Systematic literature search with documented methodology
  • Critical appraisal of identified clinical data
  • Demonstration of equivalence (if relying on data from equivalent devices)
  • Gap analysis and residual clinical risks
  • Conclusion on clinical safety and performance

Kemenkes may request local clinical performance data for some Class C device categories, particularly where:

  • The device is novel or lacks an established evidence base
  • The intended use in Indonesia differs from approved uses elsewhere
  • ASEAN-specific population or clinical practice considerations apply
warning

If Kemenkes requests local clinical data, plan for 12–24+ additional months — including BPOM clinical trial authorisation, ethics committee approval, site selection, conduct, and analysis.

Class D — Full Clinical Data Including Investigation Data​

Class D devices require the highest standard of clinical evidence:

  • Full CER per ASEAN/GHTF clinical evaluation guidance
  • Clinical investigation data (peer-reviewed publications, clinical study reports) demonstrating safety and performance for the specific device
  • Where adequate published data does not exist, a dedicated clinical investigation may be required
  • Ongoing post-market clinical follow-up (PMCF) commitment

Clinical Investigation in Indonesia​

If a clinical investigation is required (either at submission or post-approval for PMCF):

  1. BPOM approval is required before any investigation commences
  2. Ethics committee clearance from an accredited Indonesian ethics committee
  3. GCP compliance — the investigation must follow BPOM-aligned GCP guidelines
  4. Import permit (SKI) for investigational devices per shipment

See Import for Research for the clinical trial import process.

Leveraging Existing International Clinical Data​

Clinical data from the EU, US, Australia, or other ASEAN markets can and should be used to support Indonesian registration. Document the clinical data clearly in the CER, noting the source and relevance to the Indonesian intended use and patient population. Kemenkes evaluators may ask:

  • Is the intended use the same?
  • Is the patient population comparable?
  • Does the clinical evidence cover the full intended use claimed on the Indonesian label?