Regulatory Framework for Medical Devices in South Korea

Overview of the South Korean Medical Device Market

The South Korean medical device market has a market size of approximately 8.5 trillion Korean won (approximately 780 billion yen) as of 2023, with an annual average growth rate (CAGR) of approximately 6.5%. Despite being a relatively compact market with a population of 51.8 million, South Korea has established itself as a hub in the Asian medical device market through high medical standards and aggressive adoption of cutting-edge medical technologies.

Notably, South Korea is experiencing one of the world’s most rapid aging populations. The country entered an aging society in 2000 (when the population aged 65 and over reached 7%), became an aged society in 2018 (when this figure exceeded 14%), and is predicted to enter a super-aged society in 2025 (when the figure will exceed 20%). This demographic shift is driving demand for medical devices, particularly diagnostic equipment, monitoring devices, and home medical devices. According to projections from the Ministry of Food and Drug Safety (MFDS), the home medical device market is expected to grow from approximately 6 trillion won in 2019 to approximately 15 trillion won by 2025. In particular, demand is expected to increase for devices for chronic disease management, such as electrocardiographs, blood glucose meters, and blood pressure monitors, as the aging population advances.

South Korea has excellent healthcare access globally, with nearly 100% coverage by its national health insurance system. Centered around Seoul, the capital, approximately 360 general hospitals and approximately 3,500 specialty hospitals are in place. Large medical institutions such as university hospitals are particularly aggressive in adopting the latest medical devices, making them significant markets for imported medical devices.

Legal Framework for Medical Device Regulation in South Korea

Medical device regulation in South Korea is based on the Medical Device Act, which was enacted in 2003 and established a regulatory framework specific to medical devices, independent from the previous pharmaceutical law. The current regulatory system incorporates international medical device regulation harmonization while including Korea-specific requirements.

Regulatory Authorities and Their Roles

The main agencies responsible for medical device regulation in South Korea are as follows:

The Ministry of Food and Drug Safety (MFDS) is the central pharmaceutical authority that oversees medical device approvals and certifications, post-market surveillance, and GMP inspections. In 2013, it was renamed from the Korea Food and Drug Administration (KFDA) and simultaneously relocated its headquarters from Seoul to Cheongju in North Chungcheong Province. Its authority was also strengthened, becoming a ministry-level organization.

The National Institute of Medical Device Information (NIDS) is responsible for reviewing Class I medical devices.

The Korea Medical Devices Industry Association (KMDIA) functions as an industry organization providing information and aggregating industry opinions.

Medical Device Classification System

South Korea classifies medical devices into four classes based on risk. This classification system is generally aligned with international classifications, but individual device classifications are sometimes determined using Korea-specific judgment.

Class	Classification	Risk Level	Examples
Class I	Low Risk	Minimal	Medical beds, stethoscopes
Class II	Moderate Risk	Moderate	Electronic thermometers, MRI equipment
Class III	Moderate-to-High Risk	High	Artificial joints, hemodialyzers
Class IV	High Risk	Highest	Implantable cardiac pacemakers, coronary stents

Approval and Certification Process

Medical devices sold in South Korea must follow different processes depending on their class.

The Product Approval/Certification process varies by class. For Class I devices, only notification is required. For Class II devices, either certification or approval is required. For Class III and IV devices, approval is mandatory.

Manufacturing and Import License requirements specify that domestic manufacturers must obtain a manufacturing license, while importers of overseas products must obtain an import license.

The Korea License Holder (KLH) requirement mandates that overseas manufacturers designate a legal representative in South Korea. The KLH serves as the liaison between the applicant and MFDS and manages the importation of registered devices.

Matter	Class I	Class II	Class III/IV
Review Period	5 business days	25 business days	55-70 business days
Review Fee	85,000 won	2.4 million won	5.61-13.38 million won

Electronic filing through MFDS’s Electronic Medical Information System (e-DIS) is mandatory.

Technical Documentation Requirements

Approval and certification applications must include the following technical documentation.

Product overview information includes basic information such as product descriptions, intended uses, and mechanisms of action. Safety and efficacy materials include data on biological safety, electrical safety, and performance testing, with required levels varying by class. For medical devices of Class II and above, submission of inspection information and performance testing results are required. For Class IV devices, submission of a Summary of Technical Electronic Document (STED) is mandatory.

Manufacturing information includes manufacturing processes and quality management system details. For clinical data, clinical trial data may be required for new Class III and IV medical devices. However, if equivalence to existing products can be demonstrated, existing clinical data may be utilized. It should be noted that South Korea’s distinction between clinical research and clinical trials is less clear than in Japan, and new medical devices often require unique clinical trial data. This is more stringent compared to Japan, where equivalence assessment is relatively more readily accepted.

Translation requirements mandate that all technical documents must include a certified Korean translation. English translations alongside Korean are often not accepted. Foreign data prepared in English is typically acceptable, but foreign data prepared in languages other than English must be submitted with a full certified translation.

GMP (Good Manufacturing Practice) Requirements

South Korea has unique K-GMP standards called Korea Good Manufacturing Practice (K-GMP) for medical device manufacturing. Since 2014, these standards have been based on ISO 13485 but include Korea-specific requirements. Foreign manufacturers must also demonstrate K-GMP compliance, and inspections by MFDS may be conducted.

Class I medical devices are exempt from GMP review. In contrast, manufacturers of Class II devices typically undergo inspections by accredited third-party auditors (TPAs), although MFDS reserves the right to participate in audits. Manufacturers of Class III and IV devices undergo inspections by both TPAs and MFDS. In some cases, on-site inspections may be waived, with only documentary review conducted. It is noteworthy that the implementation rate for on-site sample testing for Class III/IV devices exceeds 70%, making thorough preparation essential.

Characteristic Requirements and Practical Considerations

Local language requirements mandate that applications be submitted primarily in Korean. Translation of technical documents requires specialized expertise, and coordination with law firms or consulting companies is important.

K-GMP inspection is required for Class II and above medical devices, with GMP compliance assessments conducted at manufacturing facilities. For overseas manufacturers, either documentary or on-site inspections are conducted.

The UDI (Unique Device Identification) system is being progressively implemented in South Korea. Adoption has begun with Class III/IV devices and is advancing in stages to strengthen traceability.

Post-market surveillance requires medical device manufacturers to submit adverse event reports and periodic safety information as part of post-market safety management.

Comparison with Japanese Pharmaceutical Regulation

South Korean medical device pharmaceutical regulation shares many basic frameworks with Japan’s regulatory system, as both countries classify medical devices into four classes based on risk and employ class-specific approval and certification processes. However, several important differences exist.

Regulatory independence differs in that South Korea established an independent legal framework for medical devices through the Medical Device Act in 2003, whereas Japan revised the pharmaceutical law in 2014 to the Pharmaceutical Affairs Law but does not have a standalone medical device law.

QMS evaluation and certification systems differ, with Japan having developed an advanced certification system utilizing registered certification bodies (third-party certification organizations), while South Korea relies primarily on MFDS with limited roles for certification bodies.

Pre-market approval data requirements also differ. Japan emphasizes data demonstrating equivalence, whereas South Korea more frequently requires unique test data.

GMP inspection frequency is higher in South Korea, where foreign manufacturers more frequently undergo on-site GMP inspections.

Clinical evaluation approaches differ, with Japan relatively more readily accepting clinical data evaluations based on existing literature or equivalent products. South Korea more frequently requires unique clinical trial data for novel medical devices.

Language requirement stringency is higher in South Korea, where Korean language requirements for application documents are more strict, and acceptance of English materials is limited.

Ethnic factor considerations in South Korea’s practice show a tendency to emphasize data reflecting the characteristics of Asians (Koreans) in medical device performance evaluation, though this is a customary practice rather than an official requirement.

Understanding these differences and appropriately addressing the regulatory requirements of both countries is crucial for medical device business expansion in the East Asian market.

Trends in International Harmonization

As a member of the International Medical Device Regulators Forum (IMDRF), South Korea actively participates in international regulatory harmonization. Additionally, it plays a leading role in the Global Harmonization Working Party (GHWP) and promotes expansion of Mutual Recognition Agreements (MRAs) with ASEAN countries. Harmonization is advancing particularly in the following areas:

SaMD (Software as a Medical Device) regulation is progressing with the adoption of international guidelines for medical device software. RPS (Regulated Product Submission) is advancing with the adoption of international standards for electronic submission formats. AI medical device regulation was strengthened when the AI Medical Device Review Guidelines were revised in 2024, enhancing alignment with international standards. The UDI (Unique Device Identification) system has begun phased implementation starting with Class III/IV devices.

Regarding the Medical Device Single Audit Program (MDSAP), South Korea is an affiliate member, and the “MDSAP Review Results Application Guidelines” was issued in February 2024, enabling medical device manufacturers to utilize MDSAP audit reports and certificates in their QMS evaluations.

Latest Developments (As of March 2025)

South Korean medical device regulation continues to evolve, with the following points attracting particular attention:

Regarding AI medical devices, the AI Medical Device Review Guidelines were revised in 2024, providing clearer review criteria. Clinical performance evaluation requirements for medical devices using deep learning have been clarified, and alignment with international standards has been strengthened.

For digital medical devices, the establishment of “Security Guidelines for Digital Medical Devices Against Cybersecurity Threats” is planned, with security requirements being clarified. Additionally, the establishment of “Good Manufacturing Practices for Digital Medical Devices” is being considered.

For telemedicine devices, some of the exceptional measures introduced in response to COVID-19 have been made permanent, and approval processes for telemedicine devices have been established.

For the UDI system, phased implementation has begun with Class III/IV devices, strengthening traceability.

In vitro diagnostic device regulation has been streamlined since 2024, with Class I in vitro diagnostic devices now subject only to notification requirements, and duplicate submission of quality manager qualification certificates exempted.

Regarding medical device item classification, the “Regulations on Medical Device Items and Item-Specific Classes” were partially revised in February 2024, resulting in the establishment of 42 new small-category items, the reclassification of 8 small-category items, and the redefinition of 2 small-category items.

Important Considerations

It is essential to review the latest MFDS guidance (English version: https://www.mfds.go.kr/eng/) at the time of actual application submission. In particular, details regarding clinical evaluation requirements and quality system review are revised annually, making coordination with local law firms or consulting companies strongly recommended. MFDS proactively updates regulatory developments, and it is important to monitor regulatory revisions related to AI medical devices, digital medical devices, and in vitro diagnostic devices since 2024.