Introduction to the Korea approval system and overview
The medical device approval process in South Korea is a structured framework designed to ensure the safety, efficacy, and quality of devices entering the market. Navigating this system can be complex, especially for international manufacturers unfamiliar with its unique aspects. This guide breaks down the process into four essential categories: Korean Good Manufacturing Practice (KGMP), MFDS Product Approval, Import/Manufacturing Licenses, and Reimbursement Listing. Additionally, we’ll compare these steps with the FDA’s approval system and the EU’s 2017/745 Medical Device Regulation (MDR) to provide global context.
4 Steps (4 big milestore)
1. Korean Good Manufacturing Practice (KGMP)
KGMP is South Korea's quality management system, mandate for class II-IV devices. It aligns closely with ISO13485 but includes additional localized requirements.
Process in Korea:
- Conduct an on-site or remote audit by MFDS-accredited bodies
- Ensure compliance with documentation and production standards.
- Obtain KGMP certification before product approval.
FDA Comparison:
FDA requires quality system regulation (QSR) compliance under 21 CFR part 820, which focuses on similar principles but without mandatory third-party audits for all devices.
MDR Comparison:
The MDR 2017/745 enforces ISO13485 compliances as part of its requirements but relies heavily on Notified Bodies for quality audits.
2. MFDS Product Approval
Product approval involves submitting a dossier to the Ministry of Food and Drug Safety(MFDS). Requirements depend on device classification.
Process in Korea:
- Class I : Notification only
- Class II-IV: Submit technicla documentation, clinical data(if required), and performance test results
- MFDS reviews and provides a decision
FDA Comparison:
The FDA offers three pathway: 510(k) clearance (for low-to-moderate risk), premarket Approval (PMA) for high-risk devices, and De Novo clasisfication for novel devices.
MDR Comparison:
EU MDR mandates submission to a Notified Body for clinical evaluation, even for moderate-risk devices, with stricter scrutiny on clinical evidence than MFDS.
3. Import License or Manufacturing License (Representative requirements)
An imprt license or manufacturign license is mandate. This is a concept of representative instead of overseas manufacturer.
Process in Korea:
- Foreign manufacturer must designate a Korean representative to obtain the imprt license
- Domestic companies must apply for a manufacturing license after meeting facility and KGMP standards
FDA comparison:
The FDA does not differentiate between import and manufacturing license but requires a device establishment registration for all manufactueres.
MDR comparison:
The EU MDR requires Authorized Representatives for non-EU manufactueres but no distinct import license process.
4. Reimbursement Listing
In South Korea, Obtaining a reimbursement listing from the Health insurance review and assessment service(HIRA) is critical for market access
Process in Korea:
- Submit clinical and economic data (or comparison table with predicated device)
- Justify pricing based on the device's value and cost-effectiveness
- Reimbursement apporval separate from regulatory approval
FDA comparison:
The FDA does not handle reimbursement, this falls under the centers for Medicare & Medicaide Services(CMS) in the U.S., often requiring additional evidence of cost-effectiveness.
MDR comparison:
EU MDR similarly separates reimbursement from regulatory approval, wiht each EU member state managing its reimbursement policies independently.
Conclusion of Korea approval process
Navigating South Korea’s medical device approval process involves a clear understanding of its four critical categories: KGMP certification, MFDS product approval, import/manufacturing licenses, and reimbursement listing. While these steps share some similarities with the FDA and EU MDR systems, unique features such as KGMP audits and the HIRA reimbursement process set South Korea apart. By comparing these frameworks, manufacturers can better align their strategies for global market access, ensuring compliance and streamlined approval in South Korea.