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What is MFDS Certification for Medical Devices in South Korea?
MFDS Certification for Medical Devices in South Korea
The Ministry of Food and Drug Safety (MFDS) is the central regulatory authority responsible for the approval and supervision of medical devices in South Korea. All medical devices must be registered with or approved by MFDS before they can be imported, marketed, or sold in the Korean market.
South Korea is one of Asia’s most attractive medical device markets, driven by a highly developed healthcare system, an aging population, and strong demand for innovative medical technologies. As a result, a significant share of medical devices used in Korea is manufactured abroad. MFDS certification ensures that these products meet Korean requirements for safety, quality, and performance.
Medical device regulation in Korea is governed by the Medical Device Act and its implementing regulations. MFDS evaluates medical devices using a risk-based regulatory framework, meaning the depth of review and required documentation depend on the risk level of the device.
Foreign manufacturers cannot register medical devices directly with MFDS. Instead, they must appoint a Korean in-country representative (Korean License Holder) who acts as the legal applicant and interface with the authority throughout the certification and post-market phase.
Which Products require MFDS Certification for Korea?
Medical Device Risk Classes in Korea (Class I–IV)
MFDS classifies medical devices into four risk classes, based on intended use, invasiveness, duration of contact with the body, and potential patient risk:
- Class I – Low risk medical devices
Non-invasive, non-powered or simple powered devices, no direct therapeutic action, minimal risk in case of failure. - Class II – Medium risk medical devices
Active devices, diagnostic equipment, or devices that interact with the body but do not sustain life or remain implanted. - Class III – Medium-high risk medical devices
Life-supporting, therapeutic, or long-term invasive devices where malfunction may cause serious harm. - Class IV – High risk medical devices
Implantable, life-sustaining devices or systems that directly replace or permanently support critical body functions.
The assigned risk class determines the applicable certification pathway, testing requirements, factory audit obligations, and post-market surveillance duties.
Examples of Medical Devices by MFDS Risk Class
The following examples are indicative and may vary depending on device design and intended use.
| Class I – Low Risk Devices | Class II – Medium Risk Devices | Class III – Medium-High Risk Devices | Class IV – High Risk Devices |
| Manual examination or treatment tables (e.g. manually operated examination tables, gynecological tables) | Electronic blood pressure monitors (automatic or semi-automatic sphygmomanometers) | Ventilators (hospital, transport, neonatal) (active respiratory support systems) | Implantable pacemakers (long-term cardiac rhythm management) |
| Mechanical stethoscopes (used only for acoustic transmission, no signal processing) | Pulse oximeters (non-invasive monitoring of oxygen saturation) | Anesthesia systems and vaporizers (delivery and control of anesthetic gases) | Implantable defibrillators (ICDs) (automatic detection and correction of fatal arrhythmias) |
| Radiation shielding products (e.g. lead aprons, thyroid shields, radiation gloves) | Medical sterilizers and disinfectors (steam, plasma, UV, or chemical sterilization units) | Hemodialysis machines (extracorporeal blood purification systems) | Cardiopulmonary bypass systems (temporary replacement of heart and lung function during surgery) |
| Manual blood pressure cuffs (non-electronic, used as accessories) | Diagnostic imaging systems (X-ray, CT, MRI) (general diagnostic imaging equipment) | Defibrillators (external) (active cardiac rhythm correction) | Implantable circulatory assist devices (mechanical support for heart failure patients) |
| Manual wheelchairs (purely mechanical patient transport devices) | Electric wheelchairs (powered mobility devices for patient transport) | Infant incubators (life-supporting neonatal care systems) | Implantable neurostimulation systems (deep brain, spinal cord, or peripheral nerve stimulators) |
MFDS Certification Process by Risk Class
The MFDS certification process for medical devices in South Korea follows a clearly risk-based approach. While all medical devices are regulated under the same legal framework, the practical approval pathway changes substantially depending on whether a device falls under Class I, Class II, or the higher-risk Class III and Class IV categories. As the risk class increases, MFDS applies progressively stricter requirements with regard to documentation, testing, quality system oversight, and regulatory review.
In addition to risk classification, MFDS also distinguishes between:
- Equivalent products (comparable to already approved devices),
- Improved products (modified versions of existing devices), and
- New products (novel technologies or indications).
This distinction has a direct impact on approval timelines, documentation requirements, and whether clinical evidence is required.
Class I Medical Device Notification Process
Class I medical devices are considered low risk and are therefore subject to a simplified pre-market notification procedure rather than a formal approval. For these devices, the Korean license holder submits certain product information to MFDS, including the device name, intended use and Korean labeling. In most cases, MFDS does not conduct a technical review and does not require product testing. Once the notification has been accepted, the device may be imported and marketed in Korea without further pre-market regulatory steps.
An important exception is that Class I devices which are sterile or have a measuring function are not treated as Class I for regulatory purposes. These products are handled under the Class II certification process, as MFDS considers sterility and measurement accuracy to increase regulatory risk.
Certification Process for Class II Devices
Class II medical devices follow a fundamentally different process from Class I devices. This process is centered on a technical review and conformity assessment. A defining feature of the Class II pathway is that MFDS generally does not carry out the technical review itself. Instead, the review is performed by an MFDS-designated third-party certification body.
The manufacturer, through its Korean license holder, prepares a technical file that demonstrates compliance with Korean regulatory and safety requirements. This typically includes device descriptions, risk management documentation, performance data, and evidence of conformity with applicable standards. Product testing to Korean standards can also be required. In parallel, the manufacturing site must obtain Korea Good Manufacturing Practice (KGMP) certification, which confirms that the quality management system meets Korean regulatory expectations.
Once the designated third-party body has completed its review and issued a positive evaluation, MFDS grants the product certification based on that assessment. For devices that are equivalent to already approved products, clinical data is generally not required, and the review focuses on technical conformity and comparative performance.
Class III and Class IV Medical Device Approval
Although Class III and Class IV devices share certain elements with the Class II process, such as technical documentation and KGMP requirements, the regulatory intensity increases significantly with higher risk classes. The most important difference is the direct involvement of MFDS in the review process.
For Class III and Class IV devices, MFDS itself conducts the technical and regulatory evaluation rather than delegating this task to a third-party body. The required documentation is more extensive and detailed, reflecting the increased potential impact on patient safety. Depending on the device type and the degree of equivalence to existing products, MFDS may require clinical evidence to support safety and performance claims. Review timelines are longer, and regulatory scrutiny is more intensive.
KGMP certification remains mandatory for both classes, but MFDS normally joins the inspections for higher-risk devices, particularly for implantable or life-supporting products. Class IV devices, as the highest-risk category, are subject to the most stringent requirements and are often evaluated not only for initial safety and performance, but also for long-term clinical impact.
In practical terms, MFDS certification can be understood as a stepwise escalation of regulatory control.
- Class I devices are handled through a notification-based system with minimal regulatory burden.
- Class II devices require structured certification based on technical review and KGMP compliance, largely managed through MFDS-designated third-party bodies.
- Class III and Class IV devices are reviewed directly by MFDS, with deeper technical and clinical assessment.
Korean License Holder Requirement for Foreign Manufacturers
Foreign manufacturers must appoint a Korean license holder (in-country caretaker) to act as the legal applicant and registration holder for MFDS certification.
The Korean license holder is responsible for:
- Submitting applications to MFDS
- Communicating with authorities and review bodies
- Managing Korean labeling and instructions for use
- Handling post-market surveillance and incident reporting
- Coordinating KGMP audits and renewals
- Supporting the import process of products registered in its name
Using an independent license holder, rather than a distributor, allows manufacturers to
maintain long-term flexibility for their sales and distribution network and control over their
Korean registrations.
MPR International can offer such Korean License Holder services that cover all responsibilities are related to this role.
Korea Good Manufacturing Practice (KGMP) Certification
Medical devices classified as Class II and above must comply with Korea Good Manufacturing Practice (KGMP) requirements. KGMP is based on the principles of ISO 13485 but constitutes a separate regulatory certification under Korean law. Holding an ISO 13485 certificate alone is therefore not sufficient to meet Korean regulatory requirements. KGMP certification is a mandatory prerequisite for MFDS product approval and must be obtained before a medical device can be registered in Korea. Compliance is verified through audits usually conducted by MFDS-authorized Korean certification bodies. These audits typically involve an on-site inspection of the manufacturing facility to assess the effectiveness of the quality management system and its implementation. Once granted, a KGMP certificate is generally valid for three years, after which renewal is required to maintain compliance.
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Our complete package for product certifications for Korea.
Device classification and regulatory strategy
Korean license holder services
Technical documentation review
KGMP preparation and audit support
Communication with MFDS and review bodies
Post-approval lifecycle and compliance support
Our approach is practical, transparent, and focused on minimizing time-to-market while ensuring full regulatory compliance in Korea.
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MFDS Certification FAQ
No. A Korean license holder is required, but this can be an independent third party.
No. Prior approval in the country of origin is not mandatory, though it can support the application.
KGMP is mandatory for Class II, III, and IV devices.
No. Many devices can be approved based on equivalence and technical documentation.
Depending on the risk class, from a few weeks (Class I) to several months (Class III–IV).
Yes, but this requires formal MFDS notification and approval by the previous representative.
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