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