Approval of Medical Devices in South Korea
The key to successful approval in South Korea
Over the past years, South Korea has emerged as an increasingly significant market for medical devices. To successfully introduce and commercialize medical devices in South Korea, companies must comply with the requirements set by the Ministry of Food and Drug Safety (MFDS). These requirements vary based on the risk classification of the medical device. For example, manufacturers of Class II and higher devices must demonstrate compliance with the Korean Good Manufacturing Practice (KGMP) quality system standards. Additionally, non-Korean companies are required to appoint a local representative, known as a Korea License Holder (KLH), to facilitate regulatory processes.
In order to launch a medical device in the South Korean market, companies must first meet the regulatory requirements. The Ministry of Food and Drug Safety (MFDS) oversees and establishes the regulatory framework for medical devices.
The Medical Device Safety Bureau operates under the Ministry of Food and Drug Safety (MFDS) in South Korea. This bureau is organised into three sections: Legislation, Market Surveillance, and Special Market Surveillance. The National Institute of Food & Drug Safety Evaluation (NIFDS) is responsible for evaluating medical devices, including product evaluation and the review of technical documentation.
The definition of medical devices in South Korea is regulated under Article 2 of the Medical Device Act, Act No. 14330 (December 2016). It includes instruments, machines, apparatus, materials, software, or similar products designed for use with humans or animals.
The Enforcement Decree of the Medical Device Act outlines detailed regulations and procedures for the application of the law. These include the review of technical documentation, notification of Class I medical devices, amendment applications for medical devices, and import license applications. These steps are essential for companies wishing to introduce medical devices in South Korea.
Approval Process for Medical Devices in South Korea
There are three requirements for market entry of medical devices in South Korea:
KGMP (Korean Good Manufacturing Practice):
KGMP defines the quality management system requirements for medical device manufacturers. These requirements are based on the ISO 13485 standard and include additional national requirements, such as language requirements for labeling. Compliance with these requirements is mandatory for manufacturers of Class II and higher devices. Only after receiving the KGMP certificate can the manufacturer submit an application for product registration.
Local Representative KLH (Korea License Holder)
Foreign manufacturers are required to appoint a local representative in South Korea. This representative serves as the intermediary between the manufacturer and the MFDS or the accredited body for regulatory matters. Additionally, the KLH holds the medical device license and can act as an importer. The KLH must fulfil the following conditions:
- Residence and registered office in South Korea
- Registration as an authorized KLH with the MFDS and possession of an import license
- Registered quality manager in accordance with MFDS requirements
Apart from supporting product registration and acquiring the KGMP certificate, the KLH has the following responsibilities:
- Registration for reimbursement and listing on the reimbursable medical devices list
- Annual and monthly reporting to the MFDS for imports and UDI
- Submission of license modifications for design changes
- Compliance with Korean labeling requirements and maintenance of the DMR (Device Master Record)
- Continuous market surveillance for quality assurance
Product Registration in South Korea: Risk Classification
The registration of medical devices in South Korea begins with identifying their risk class, which defines the specific requirements and approval processes.
There are four risk classes according to the Global Harmonization Task Force (GHTF) classification system:
- Class I: Very low risk
- Class II: Low risk
- Class III: Moderate risk
- Class IV: High risk
Classification Rules: The classification rules are defined in Notification 2017-6, "Medical Device Classification." Article 3 refers to an annex that assigns each medical device to a specific class. This enables manufacturers to identify the classification of their medical device.
If the medical device is classified as Class I, a notification is required. For Class II, III, and IV devices, the registration process depends on whether a similar product is already available in South Korea. Class II devices that can reference an equivalent or modified product will have their submission documentation reviewed by an accredited body (3rd Party review). For all other classes, the MFDS is responsible for the evaluation of the documentation.
Class I - Notification
Medical devices in Risk Class I are registered in South Korea via Pre-Market Notification. This registration is carried out electronically by the National Institute of Medical Device Safety Information (NIDS).
Class II - Certification or Approval Based on Equivalent Products
For Class II medical devices in South Korea, the submission process depends on whether an equivalent product is already on the market. There are four types:
- Equivalent Product
(Substantially Equivalent Device, SE Device): A product that is considered equivalent to the one being registered in aspects such as intended use, mechanism of action, materials used, performance, testing specifications. Certification is provided by an MFDS-accredited body in this case. - Recognized Equivalent Product (Recognized SE Device):
If more than three equivalent products of a medical device type are available on the market, the MFDS may classify it as a recognized equivalent product. This category involves the least submission effort. - Modified Product:
This medical device is equivalent in terms of intended use, mechanism of action, and materials but differs in performance, testing specifications, and instructions for use. Additional documentation is required compared to the first category. - New (Novel) Product:
As there is no equivalent product on the market, it is treated as a new product. Approval from the MFDS is required, including the submission of clinical data.
New Class II, Class III, and IV: Submission to MFDS
New medical devices in Risk Class II, as well as Class III and IV (regardless of whether there is an equivalent product), must be approved by the MFDS.
For Class III and IV medical devices with an equivalent product, an extensive review of the Technical Documentation (TDR) is necessary.
Class IV medical devices require Technical Documentation in the STED format in Korean. The appendices do not need to be translated at the initial stage.
Test Reports
Test reports included in the Technical Documentation must meet both national requirements in South Korea and international standards.
If the submitted test reports are found to be inadequate, additional testing may be required. Such additional tests must be carried out by laboratories accredited by the Korean regulatory authority (MFDS).
Review of Technical Documentation and Safety/Efficacy
While the Technical Documentation Review (TDR) is adequate for medical devices with an equivalent product, new medical devices in Risk Classes II, III, and IV without an equivalent product require an additional Safety and Efficacy Review (SER). The SER focuses on the safety and effectiveness of new features not previously available in South Korea. This submission includes a clinical study.
Market Surveillance
In South Korea, the KLH is responsible for market surveillance. Manufacturers must report adverse events within the following timeframes:
- Within seven days: Adverse events that resulted in death or are life-threatening
- Within 15 days:
- Hospitalization or prolonged hospitalization
- Irreversible or serious disability or impairment of function
- Presence of a congenital anomaly or abnormality
- Within 30 days: All other adverse events
Notification of Changes
Any modifications affecting the license must be reported. Changes that impact the safety and effectiveness of the medical device or manufacturer information require approval. Minor changes, on the other hand, can be submitted as a notification. The changes will be recorded in the certificate.
Summary: Regulation of the Medical Device Market in South Korea
The medical device market in South Korea is regulated by strict requirements. Key regulatory aspects include:
- KGMP Quality Management System Requirements: Based on ISO 13485, compliance is mandatory for all Class II, III, and IV devices.
- Determination of Risk Class: Identifying the risk class of the medical device to be registered.
- Equivalent Products: Reducing registration effort through equivalent products.
- Designation of a Local Representative (KLH): Foreign manufacturers must appoint a KLH who acts as a liaison between the manufacturer and the regulatory authority.
- Korean Labeling: Must be completed prior to market entry.
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