Classification Rules and Criteria
Primary method — product code lookup
The most straightforward approach: look up your product in the MFDS Classification Table which assigns a specific grade to each listed device type. Search via udiportal.mfds.go.kr.
When the table does not apply
Submit a product classification inquiry (분류 민원) via the MFDS eSubmission portal when:
- Your product is novel and not yet listed
- Your product could fall under multiple product types
Key classification factors
| Factor | Determines |
|---|---|
| Intended use and body contact | Primary grade driver |
| Duration of contact | Transient / short-term / long-term |
| Invasiveness | Surface / body orifice / surgically invasive / implantable |
| Active vs non-active | Energy delivery raises grade |
Software, accessories, and combination products
- SaMD: classified by intended function and risk — see SaMD classification
- Accessories: classified independently from the parent device
- Combination products: MFDS determines which Act governs — see Combination products