Question 1

How much does South Korea medical device registration cost?

Accepted Answer

South Korea (MFDS) medical device registration fees range from KRW 85,000 to KRW 1,495,000 depending on device class. S.E. = Substantial Equivalent (predicate device exists)

Question 2

What fees does MFDS charge for medical devices?

Accepted Answer

Approval - Class 1: KRW 85,000. Approval - Class 2 (with S.E.): KRW 130,000. Approval - Class 2 (without S.E.): KRW 1,495,000. Approval - Class 3/4 (with S.E.): KRW 719,000. Approval - Class 3/4 (without S.E.): KRW 1,495,000.

Question 3

Are South Korea medical device fees annual or one-time?

Accepted Answer

Fee structure: Per approval. See the full breakdown for details on each fee category.

Fee Item	Amount	Frequency
Approval - Class 1 Pre-market notification	KRW 85,000	Per approval
Approval - Class 2 (with S.E.) 35 days · Substantial equivalent	KRW 130,000	Per approval
Approval - Class 2 (without S.E.) 80 days · Requires clinical data	KRW 1,495,000	Per approval
Approval - Class 3/4 (with S.E.) 65 days · Substantial equivalent	KRW 719,000	Per approval
Approval - Class 3/4 (without S.E.) 80 days · Requires clinical data	KRW 1,495,000	Per approval

South Korea Medical Device Registration Fees

How much does South Korea medical device registration cost?

Are these one-time or annual fees?

What other costs should I budget for?