Combination Products — Drug-Device
A combination product combines a medical device with a pharmaceutical, biological, or IVD reagent. Common examples: drug-eluting stents, prefilled syringes, drug-coated balloons.
Lead regulator determination
MFDS determines the applicable regulatory pathway based on the Primary Mode of Action (PMOA):
| PMOA | Regulatory pathway |
|---|---|
| Device component achieves primary effect | Medical Devices Act (MFDS device division) |
| Drug/biological component achieves primary effect | Pharmaceutical Affairs Act (MFDS pharma division) |
When the PMOA is unclear, submit a combination product determination inquiry to MFDS.
Technical documentation requirements
Must address both device and drug aspects: device performance/safety data + drug pharmacological data (compatibility, stability, leachables), and a combined safety evaluation.