South Korea, known for its advanced healthcare system and technological prowess, has a robust framework for regulating medical devices. Whether you are a domestic manufacturer or an international company looking to bring your products to South Korea, understanding the registration process is crucial for compliance and market access. This blog provides an overview of the regulatory processes, key agencies, and essential requirements for medical devices in South Korea.
Health Authority for Regulation of Medical Devices in South Korea
In South Korea, the regulation of medical devices is primarily overseen by the Ministry of Food and Drug Safety (MFDS), formerly known as the Korea Food and Drug Administration (KFDA), which is responsible for ensuring the safety and efficacy of these products. Complementing the MFDS are –
Medical Device Information and Technology Assistance Center (MDITAC)
National Institute of Medical Device Safety Information (NIDS) has been entrusted with tasks related to the notification and certification of medical devices
Together, these organizations form a comprehensive regulatory framework designed to uphold high standards of medical device safety and performance in South Korea.
MFDS Laws and regulations for Medical Devices in South Korea
South Korea's regulatory framework for medical devices is grounded in a comprehensive set of laws and regulations designed to ensure the safety, efficacy, and quality of these products. Key components of this framework include:
Medical Devices Act (MDA) - The Medical Devices Act (MDA) is the cornerstone of South Korea’s regulatory framework for medical devices. Enacted to govern the manufacture, import, distribution, and use of medical devices, the MDA outlines the fundamental requirements for device registration, classification, and approval processes.
Enforcement Decree of MDA - The Enforcement Decree of the MDA provides detailed provisions on the implementation of the MDA. It elaborates on the procedural aspects of the Act, including requirements for clinical trials, device registration procedures, and conditions for approval. This decree ensures that the general principles laid out in the MDA are translated into actionable regulations.
Enforcement Regulations of MDA - Supplementing the Enforcement Decree, the Enforcement Regulations of the MDA offer framework for major regulatory programs and further specifics on the administrative processes and technical requirements necessary for compliance. These regulations cover a range of topics, from the detailed classification of devices to the stipulations for reporting adverse events and maintaining post-market surveillance.
MFDS Notification related to MDA - The Ministry of Food and Drug Safety (MFDS) issues various notifications that provide additional guidance and clarifications related to the MDA. These notifications can include updates on regulatory changes, procedural requirements, and industry best practices. They play a crucial role in ensuring that stakeholders are informed about the latest regulatory expectations and compliance requirements. Most detailed regulations for technical requirements review
MFDS Standards and Guidelines - In addition to the MDA and its associated decrees and regulations, the MFDS publishes standards and guidelines that outline specific technical and quality requirements for medical devices. These documents provide detailed instructions on aspects such as labeling, clinical evaluation, and manufacturing practices. They are essential for ensuring that medical devices meet the stringent quality and safety standards required for approval and market entry in South Korea.
Together, these laws and regulations form a robust framework designed to regulate the medical device industry in South Korea, ensuring that all products meet rigorous standards for safety and effectiveness before reaching the market.
MFDS Classification of Medical Devices in South Korea
Medical devices and IVDs in South Korea are classified into four categories based on their risk levels:
Class I: Very Low Risk Devices (e.g., bandages, non-sterile gloves)
Class II: Low Risk Devices (e.g., infusion pumps, diagnostic equipment)
Class III: Moderate Risk Devices (e.g., pacemakers, implantable devices)
Class IV: High Risk Devices (e.g., artificial heart valves, advanced diagnostic imaging systems)
The classification determines the level of regulatory scrutiny and the approval process required.
MFDS Local representative requirements for Medical Devices in South Korea
To navigate the South Korean medical device market, manufacturers are required to appoint a local representative. This representative can be a subsidiary, importer, distributor, or an independent Korean License Holder (KLH). Here are the key requirements and responsibilities for a KLH:
Requirements for a KLH:
South Korean Citizenship: The KLH must be a South Korean citizen, ensuring local representation and a thorough understanding of national regulatory requirements.
Business License: The KLH must hold a valid business license for medical device importation, demonstrating their capacity to engage in the import and distribution of medical devices.
MFDS Registration: The KLH must be officially registered with the MFDS, which involves meeting specific regulatory criteria and maintaining compliance with South Korean laws.
Quality Manager: The KLH is required to employ a qualified quality manager to oversee the adherence to quality standards and regulatory requirements.
Responsibilities of a KLH:
Liaison Role: The KLH acts as the primary liaison between the manufacturer and the MFDS, ensuring effective communication and facilitating regulatory processes.
GMP Application: They are responsible for handling the Good Manufacturing Practice (GMP) application process, which is essential for ensuring that medical devices are manufactured in accordance with quality standards.
Product Registration: The KLH manages the registration of medical devices with the MFDS, a crucial step for obtaining market approval and ensuring compliance with local regulations.
Product License Ownership: The KLH holds the product license, thereby taking responsibility for the legal authorization required to market and distribute the device in South Korea.
Post-Market Surveillance (PMS) Compliance: They ensure that post-market surveillance requirements are met, including monitoring the device's performance and managing any adverse events or recalls.
Additional Considerations for the KLH
Dual KLH Appointments: A single medical device can have two KLHs appointed for its importation into South Korea. Each KLH will be distinguished by its name on the product certificate. To appoint a second KLH, the manufacturer must establish a formal contract and re-register the device under the new KLH.
Labeling Requirements: The MFDS mandates that the information (name and registered address) of the KLH must be included on the medical device and in vitro diagnostic (IVD) labels. This ensures transparency and compliance with South Korean labeling regulations.
MFDS Medical Device Registration Pathways in South Korea
Medical devices must obtain product registration or approval and quality compliance certification before being introduced to the South Korean market. There are three registration pathways available:
Pre-Market Notification
Pre-Market Certification
Pre-Market Approval
MFDS GMP Requirements for Medical Devices in South Korea Class II, III, and IV medical devices and IVDs must secure a KGMP Certificate before they can be registered. In contrast, Class I medical devices and IVDs are not required to obtain GMP Certification. Depending on the risk classification, on-site inspections may be carried out by either a third-party reviewer or the MFDS.
MFDS Labeling and UDI Requirements for Medical Devices in South Korea
Articles 20-23 of the Medical Device Act outline the labeling requirements. All labeling must be provided in the Korean language. Starting from 2019, UDI barcode labeling is required for medical devices based on their classification: Class IV devices in 2019, Class III in 2020, Class II in 2021, and Class I in 2022.Devices must be registered in a specific database managed by the Medical Device Information & Technology Assistance Center (MDITAC), which tracks production, marketing, and usage information for device traceability.
MFDS Documentation Requirements for Medical Devices in South Korea
The Technical File application must be provided in Korean, though foreign data in English is usually acceptable. If the data is in a language other than English, a notarized translation of the entire text is required. Documentation for Class IV medical devices must be submitted in STED Format, while for Class III and Class II (New Devices), the use of STED format is optional.
MFDS Pre-Requisites for Medical Device Registration in South Korea
To register a medical device in South Korea, you must obtain a Manufacturing Business License if you are a domestic manufacturer, or an Import Business License if you are importing medical devices and IVDs. These licenses should be obtained from the regional MFDS office where the business is located. Approvals from the health authority of the country of origin are not required.
MFDS Validity of Medical Device Approvals in South Korea
In South Korea, medical device approvals are valid for 5 years, whereas the KGMP Certificate is valid for 3 years. This distinction ensures that while device approvals have a longer validity period, the quality management certification needs to be renewed more frequently.
MFDS License Transfer for Medical Devices in South Korea
To transfer medical device registration or approval, you must transfer the KGMP certificate and re-register the device under the new KLH. This process ensures that the device continues to meet regulatory standards under the new license holder.
The registration of medical devices in South Korea is a complex process that requires careful planning, thorough documentation, and adherence to strict regulatory standards. However, with the right preparation and understanding of the regulatory landscape, companies can successfully navigate the MFDS registration process and gain access to the lucrative South Korean market.
If you're looking to register a medical device in South Korea, partnering with regulatory experts like Artixio can simplify the process and ensure compliance with all local regulations. Contact us today at info@artixio.com to learn how we can support your registration efforts and help bring your medical device to market in South Korea.
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