Publication Date: 12/09/2025
Department: Medical Device Safety Bureau, Ministry of Food and Drug Safety (MFDS)
To ensure transparency and facilitate the medical device approval process, the Ministry of Food and Drug Safety (MFDS) provides this clear breakdown of all applicable fees for product licensing. Understanding the fee structure is essential for all manufacturers and Korean Marketing Authorization Holders (K-MAHs) planning to submit an application.
This article outlines the official fees for technical document review and license issuance for Class I, II, III, and IV medical devices, as stipulated in the Enforcement Regulations of the Medical Devices Act and the Notification on Fees for Approval and Review of Medical Devices.
MFDS Fee Structure for Medical Device Approval in South Korea
1. Understanding the Two Main Fee Types
The total cost for obtaining marketing authorization for a medical device consists of two primary fees payable to the MFDS:
- Technical Document Review Fee (품목 심사 수수료): This fee is for the scientific and technical evaluation of the submission dossier to ensure the device’s safety, efficacy, and quality.
- Medical Device License (Permit) Issuance Fee (의료기기 허가증 발급 수수료): This is a fixed administrative fee for issuing the official approval certificate once the review is successfully completed.
2. Fee Schedule for All Medical Device Classes
The following table provides the standard fees for a single medical device application. Fees are subject to change based on relevant legislation; please always confirm via the official MFDS Fee Calculator.
| Medical Device Class | Technical Document Review Fee (KRW) | License Issuance Fee (KRW) | Total Estimated Fee (KRW) |
| Class I (General) | ₩ 196,000 | ₩ 117,000 | ₩ 313,000 |
| Class II (Medium Risk) | ₩ 4,924,000 | ₩ 117,000 | ₩ 5,041,000 |
| Class III (High Risk) | ₩ 7,386,000 | ₩ 117,000 | ₩ 7,503,000 |
| Class IV (Very High Risk) | ₩ 9,848,000 | ₩ 117,000 | ₩ 9,965,000 |
3. Important Notes and Additional Fee Scenarios
The base fees above apply to a standard, single-device application. Please be aware of the following scenarios which may affect the total fee payable:
- Kits and Sets: For medical devices that are kits or sets comprising multiple articles, an additional ₩ 1,000,000 is added to the Technical Document Review Fee.
- Re-examination Fee: If an application is rejected and subsequently re-submitted, a re-examination fee will apply. This fee is typically 50% of the original technical review fee for the corresponding device class.
- KGMP Audit Fees: Please note that the mandatory Korean Good Manufacturing Practice (KGMP) audit fees are separate and are paid directly to the accredited auditing organization, not the MFDS. The cost varies based on the complexity and location of the manufacturing facility.
- Third-Party Review (For certain Class II devices): Some Class II devices eligible for a third-party review will have a different fee structure set by the accredited third-party organization.
