South Korea Medical Device Regulations: Complete Guide for Global Manufacturers

Compliance with South Korea medical device regulations involves more than leveraging an existing FDA, CE, PMDA, or NMPA approval. Even with prior certifications, manufacturers must comply with a distinct regulatory system governed by South Korea’s Medical Devices Act, its subordinate regulations, and detailed requirements from the Ministry of Food and Drug Safety (MFDS).

The Korean framework governs the entire product lifecycle, from classification and product authorization to KGMP compliance, labeling, import controls, and post-market surveillance. Manufacturers must therefore develop a Korea-specific regulatory strategy including product classification, Korean License Holder (KLH) appointment, KGMP readiness, and market authorization planning rather than treating South Korea as an extension of another market.

For full details on South Korea medical device regulations, continue reading, or contact Cisema for support with South Korea medical device registration and MFDS compliance.

South Korea Medical Device Legislative Framework

South Korea’s regulatory system for medical devices is structured as a legal hierarchy comprising:

1. Medical Devices Act 
2. Enforcement Decree of the Medical Devices Act 
3. Enforcement Rule of the Medical Devices Act 
4. MFDS Notifications and Administrative Guidance 

Together, these instruments regulate the entire product lifecycle, including:

• Device classification 
• Product notification, certification, and approval 
• Manufacturing and import licensing 
• Quality management systems 
• Labeling and advertising 
• Change management 
• Adverse event reporting 
• Product recalls and corrective actions 
• Post-market surveillance 

The framework applies not only to domestic manufacturers, but also to importers, distributors, authorized Korean license holders, and foreign manufacturers supplying products to the Korean market.

Key Regulatory Authorities

Several organizations perform regulatory functions under the authority of the Ministry of Food and Drug Safety.

Ministry Of Food and Drug Safety (MFDS)

The Ministry of Food and Drug Safety serves as the competent authority for medical devices under the Medical Devices Act.

MFDS is responsible for:

• Medical device regulation and policy 
• Device classification 
• Product authorization 
• KGMP oversight 
• Regulatory inspections 
• Import controls 
• Post-market surveillance 
• Enforcement activities 

Although some operational activities are delegated to affiliated organizations, MFDS retains ultimate responsibility for medical device regulation and market authorization. 

National Institute of Food and Drug Safety Evaluation (NIFDS)

National Institute of Food and Drug Safety Evaluation serves as the scientific review arm of MFDS. It conducts technical evaluations for higher-risk devices, including assessments of:

• Clinical evidence 
• Performance data 
• Risk management documentation 
• Software validation 
• Biocompatibility 
• Usability

National Institute of Medical Device Safety Information (NIDS)

The National Institute of Medical Device Safety Information was established pursuant to Article 42 of the Medical Devices Act and performs delegated regulatory functions assigned by MFDS.

NIDS supports notification and certification activities for eligible lower-risk devices and assists in administrative processing related to product registration and safety information management.

Core Regulatory References

The legal framework described above is implemented through several key regulatory instruments that manufacturers should understand before beginning market access activities.

The Medical Devices Act

The Medical Devices Act is the principal legislation governing medical devices in South Korea.

The Act establishes the legal basis for:

• Medical device classification 
• Manufacturing and import business licensing 
• Product notification, certification, and approval 
• Quality management and inspections 
• Adverse event and side effect reporting 
• Labeling and advertising controls 
• Corrective actions and recalls 
• Administrative enforcement 

These obligations apply regardless of where design, manufacturing, or corporate decision-making occurs. Consequently, foreign manufacturers must ensure that their global quality systems and technical documentation can support Korean regulatory obligations.

Enforcement Decree and Enforcement Rule of The Medical Devices Act

The Enforcement Decree and Enforcement Rule operationalize the Medical Devices Act by establishing detailed procedural requirements, including:

• Application procedures 
• Submission documentation 
• Quality management obligations 
• Classification criteria 
• Labeling requirements 
• Record retention 
• Safety reporting 
• Post-market surveillance 
• Change notification procedures 

Only the Korean-language version is legally binding; English translations are for reference only. 

MFDS Notifications

Many operational requirements are established through MFDS notifications rather than the Medical Devices Act itself.

Key examples include:

• Regulation on the Permission, Notification, Review, Etc. of Medical Devices 
• Regulations on Labeling and Description of Medical Devices 
• Regulations on Unique Device Identification Management of Medical Devices 
• Regulation on Management of Safety Information Including Medical Device Side Effects, Etc. 

Manufacturers should therefore identify the specific notification applicable to their product category rather than relying solely on the Act.

KGMP Requirements (Quality System Control Under MFDS Law)

Korean Good Manufacturing Practice (KGMP) requirements form part of the quality management framework established under the Medical Devices Act and related MFDS regulations.

KGMP is implemented through the Standards of Good Manufacturing Practice for Medical Devices, as well as related standards applicable to in-vitro diagnostic medical devices and digital medical devices.

MFDS has also published an English compilation of GMP regulations (February 2026), including these standards and relevant provisions of the Enforcement Rule.

Although ISO 13485 certification supports compliance readiness, it does not replace KGMP requirements, as MFDS applies Korea-specific procedural and inspection criteria. Many overseas manufacturers mistakenly assume that ISO 13485 certification alone is sufficient for Korean market entry. In practice, KGMP compliance remains a separate regulatory requirement, and working with an experienced local regulatory partner can help manufacturers avoid unnecessary delays and compliance issues.

Medical Device Classification in South Korea

Medical device classification is governed by the Medical Devices Act and detailed classification criteria established through MFDS notifications and regulatory guidance.

MFDS applies a four-tier, risk-based classification system aligned with GHTF/IMDRF principles. The applicable regulatory route is determined by risk level, novelty, and equivalence to existing devices.

According to the MFDS Medical Devices Approval Process framework:

For Class II devices:

• Certification (via NIDS): Applies where substantial equivalence can be demonstrated in intended use, mechanism of action, materials, performance, and labeling.
• Approval (MFDS/NIFDS): Applies where the device is novel, lacks equivalence, introduces new technology, requires clinical evidence, or involves combination-product or digital health features.

Although certification is generally more streamlined than approval, manufacturers must still prepare technical documentation that satisfies Korean regulatory requirements.

Special Regulatory Considerations

Certain device categories are subject to additional MFDS regulatory requirements that may affect classification, evidence burden, or approval pathways.

In Vitro Diagnostic Medical Devices

In-vitro diagnostic (IVD) medical devices are regulated under a dedicated legislative framework comprising the Act on In-Vitro Diagnostic Medical Devices (체외진단의료기기법), its implementing regulations, and applicable GMP requirements. 

Manufacturers should not assume that regulatory requirements applicable to general medical devices automatically apply to IVDs.

AI-Based Medical Devices

South Korea has emerged as a leading regulator of AI-enabled medical devices, with the MFDS issuing multiple guidance documents covering artificial intelligence, machine learning, software as a medical device (SaMD), and digital therapeutics. 

Depending on the product, manufacturers may be expected to provide additional evidence relating to:

• Software validation 
• Algorithm performance and reliability 
• Clinical evaluation 
• Data quality and integrity 
• Cybersecurity 
• Post-market monitoring and software change management 

AI-specific regulatory considerations should be assessed early in product development to align supporting evidence with MFDS expectations.

Digital Medical Devices

Digital products may also fall within the scope of the Digital Medical Products Act, which introduced a dedicated framework for software-based and digital healthcare technologies. As a result, depending on the product's characteristics and intended use, manufacturers may need to comply with both the Medical Devices Act and the Digital Medical Products Act.

Manufacturers should evaluate requirements relating to:

• Software lifecycle management 
• Cybersecurity 
• Data governance 
• Version control 
• Product maintenance 
• Digital medical device GMP

Innovative Medical Devices

The Medical Device Industry Promotion and Innovative Medical Device Support Act established Korea's innovative medical device designation program.

Eligible products may benefit from:

• Priority consultation 
• Accelerated review 
• Regulatory support measures 
• Expedited market access opportunities 

Manufacturers developing AI, robotics, digital health, or other breakthrough technologies should assess eligibility early in the regulatory planning process.

Post-Market Controls

Regulatory obligations do not end once a device receives authorization.

Under the Medical Devices Act and the Regulation on Management of Safety Information Including Medical Device Side Effects, Etc., manufacturers and Korean license holders remain responsible for ongoing compliance throughout the product lifecycle.

Key post-market obligations include:

• Adverse event reporting under MFDS safety information regulations 
• Complaint handling and safety signal escalation 
• Corrective and preventive actions (CAPA) in accordance with MFDS quality system requirements 
• Maintenance of traceability and regulatory quality records 
• Labeling updates, UDI management, and safety communication controls 
• Field safety corrective actions and product recalls under MFDS enforcement authority 

Any significant modification affecting intended use, design, manufacturing processes, software functionality, materials, sterilization methods, or labeling should be evaluated against applicable MFDS change-management requirements before implementation.

Final Thoughts

South Korea is often regarded as a relatively accessible medical device market because its regulatory framework is built on internationally recognized risk-based principles. Yet manufacturers frequently encounter delays when they assume that an FDA, CE, or other overseas approval can be transferred into the Korean system with minimal adaptation.

The companies that achieve the most efficient market entry are those that treat Korea as a distinct regulatory jurisdiction from the outset. This is becoming increasingly important as MFDS expands its oversight of digital health technologies, AI-enabled devices, software lifecycle management, and post-market performance.

For companies seeking support with South Korea medical device registration and ongoing regulatory requirements, contact Cisema today for tailored, local support throughout the product lifecycle.

About the Author: Will Noh

Will Noh brings more than 14 years of Regulatory Affairs and Quality Assurance experience across the medical device and healthcare industries, with deep expertise in South Korea’s Ministry of Food and Drug Safety (MFDS) regulatory framework. As Regulatory Affairs Manager at Cisema Korea, he supports international companies seeking market access in South Korea, providing regulatory, quality, and Local Authorized Representative (LAR) services for pharmaceuticals, medical devices, quasi-drugs, and cosmetics.

Further Information

Explore Cisema's services for medical device registration in South Korea.

References

• Act on In-Vitro Diagnostic Medical Devices (체외진단의료기기법)
• ⁠Digital Medical Products Act (디지털의료제품법)
• Enforcement Decree of the Medical Devices Act (의료기기법 시행령)
• Enforcement Rule of the Act on In Vitro Diagnostic Medical Devices (체외진단의료기기법 시행규칙)
• Enforcement Rule of the Medical Devices Act (의료기기법 시행규칙)
• Guidelines for Approval and Review of Generative AI Medical Devices (생성형 인공지능 의료기기 허가·심사 가이드라인)
• Medical Device GMP Regulations (의료기기 제조 및 품질관리기준)
• Medical Devices Act (의료기기법)
• MFDS Medical Devices Approval Process (의료기기 허가·인증·신고 절차)
• Regulation on Management of Safety Information Including Medical Device Side Effects, Etc. (의료기기 부작용 등 안전성 정보 관리에 관한 규정)
• ‍‍Regulations on Labeling and Description of Medical Devices (의료기기 표시·기재 등에 관한 규정)‍
• Regulations on Unique Device Identification Management of Medical Devices (의료기기 표준코드의 표시 및 관리요령)‍
• Regulation on the Permission, Notification, Review, Etc. of Medical Devices (의료기기 허가/신고/심사 등에 관한 규정)‍
• Standards of Good Manufacturing Practice for Digital Medical Devices (디지털의료제품 제조 및 품질관리기준)