Clinical Data Requirements by Grade

Grade	Clinical data requirement
I	Generally not required. Bench testing and literature sufficient.
II	Not always required. Literature may suffice for established device types.
III	Required. Clinical evaluation report or data from recognised clinical studies.
IV	Required. Robust clinical trial data or extensive published literature.

For IVDs: Grade A/B require performance data; Grade C/D require formal performance evaluation studies.

Acceptable forms of clinical data

1. Korean clinical trial data (highest weight)
2. Foreign clinical trial data (if population and use are relevant)
3. Published scientific literature (systematic review acceptable for established technologies)
4. Post-market clinical follow-up data

When MFDS requires a Korean trial

• Foreign data not applicable to the Korean population
• First-in-class novel technology
• Specific MFDS safety/performance concerns