Clinical Evidence
Clinical evidence is a key element of the technical dossier for Type C and Type D devices. Vietnam follows an ASEAN-aligned approach to clinical evaluation that permits use of published literature and foreign clinical data, reducing the need for fresh local clinical investigations in many cases.
What clinical data is required?
The level of clinical evidence required is proportionate to device risk:
| Device class | Clinical evidence expectation |
|---|---|
| Type A | No clinical data required in the dossier |
| Type B | Brief clinical evaluation summary acceptable |
| Type C | Full clinical evaluation report (literature review + gap analysis) |
| Type D | Comprehensive clinical evidence; clinical investigation data usually expected |
Clinical evaluation report
For Type C and D devices, a Clinical Evaluation Report (CER) is required. The CER should:
- Define the intended purpose and target patient population
- Identify applicable clinical performance standards and acceptance criteria
- Summarise the clinical literature (systematic search and appraisal)
- Assess whether clinical equivalence to predicate devices can be established
- Identify and address any residual clinical risks
- Conclude on the clinical safety and performance of the device
Vietnam accepts CERs prepared to IMDRF MDCE guidance or MEDDEV 2.7/1 Rev 4 (EU) standards as the basis for the clinical evidence module.
Clinical investigations (trials) in Vietnam
Where existing clinical data is insufficient — particularly for novel Type D devices — DAV may require or accept a local clinical investigation. Clinical investigations in Vietnam are governed by Circular 29/2022/TT-BYT and require:
- Ethics Committee approval from a recognised Vietnamese institutional ethics committee
- DAV approval of the investigation plan before commencement
- Informed consent procedures compliant with Vietnamese research ethics law
- Compliance with GCP (Good Clinical Practice) principles
The investigation sponsor must notify DAV of serious adverse events occurring during the investigation.
Using foreign clinical data
Vietnam accepts clinical data generated in other countries as part of the clinical evidence module, provided:
- The data relates to the same device (or an equivalent device) as submitted
- The foreign clinical context is relevant to Vietnamese patients and clinical practice
- The data is from well-conducted studies with appropriate ethical oversight
Foreign approval decisions (e.g. CE marking, FDA clearance, TGA approval) can be cited as supporting evidence but do not substitute for a complete clinical evaluation.
IVD clinical performance
For IVD devices, clinical evidence takes the form of analytical performance and clinical performance data:
- Analytical performance: sensitivity, specificity, precision, accuracy vs reference method
- Clinical performance: diagnostic sensitivity, diagnostic specificity in the target population
These studies must use appropriate reference standards and be conducted in relevant patient populations.
If your device already holds CE marking or FDA clearance, the clinical evidence compiled for those submissions — particularly the CER — can form the basis of the Vietnamese clinical module, with localisation as needed. This significantly reduces the preparation burden.