{"id":24868,"date":"2026-02-16T16:13:49","date_gmt":"2026-02-16T15:13:49","guid":{"rendered":"https:\/\/www.korea-certification.com\/?page_id=24868"},"modified":"2026-02-26T16:42:53","modified_gmt":"2026-02-26T15:42:53","slug":"mfds-certification-en","status":"publish","type":"page","link":"https:\/\/www.korea-certification.com\/en\/mfds-certification-en\/","title":{"rendered":"MFDS Certification EN"},"content":{"rendered":"\n<h4 class=\"wp-block-heading is-style-header-headline-white\">your one-stop certification <strong>solution!<\/strong><\/h4>\n\n\n\n<h1 class=\"wp-block-heading is-style-h1-headline-content\"><strong>What is MFDS Certification for Medical Devices in South Korea?<\/strong><\/h1>\n\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading is-style-border-left-headline\"><strong>MFDS Certification for Medical Devices in South Korea<\/strong><\/h2>\n\n\n\n<p><strong>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.<\/strong><\/p>\n\n\n\n<p>South Korea is one of Asia\u2019s 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.<\/p>\n\n\n\n<p>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.<\/p>\n\n\n\n<p>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.<\/p>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-1 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<p><\/p>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full is-resized\"><img loading=\"lazy\" decoding=\"async\" width=\"435\" height=\"116\" src=\"https:\/\/www.korea-certification.com\/wp-content\/uploads\/ministry-of-food-and-drug-safety-korea-logo.png\" alt=\"ministry-of-food-and-drug-safety-south-korea-logo\" class=\"wp-image-24869\" style=\"width:300px\" srcset=\"https:\/\/www.korea-certification.com\/wp-content\/uploads\/ministry-of-food-and-drug-safety-korea-logo.png 435w, https:\/\/www.korea-certification.com\/wp-content\/uploads\/ministry-of-food-and-drug-safety-korea-logo-300x80.png 300w\" sizes=\"(max-width: 435px) 100vw, 435px\" \/><\/figure><\/div><\/div>\n<\/div>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading is-style-border-left-headline\">Which Products require MFDS Certification for Korea?<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Medical Device Risk Classes in Korea (Class I\u2013IV)<\/strong><\/h3>\n\n\n\n<p>MFDS classifies medical devices into four risk classes, based on intended use, invasiveness, duration of contact with the body, and potential patient risk:<\/p>\n\n\n\n<ul>\n<li><strong>Class I \u2013 Low risk medical devices<\/strong><br>Non-invasive, non-powered or simple powered devices, no direct therapeutic action, minimal risk in case of failure.<\/li>\n\n\n\n<li><strong>Class II \u2013 Medium risk medical devices<\/strong><br>Active devices, diagnostic equipment, or devices that interact with the body but do not sustain life or remain implanted.<\/li>\n\n\n\n<li><strong>Class III \u2013 Medium-high risk medical devices<\/strong><br>Life-supporting, therapeutic, or long-term invasive devices where malfunction may cause serious harm.<\/li>\n\n\n\n<li><strong>Class IV \u2013 High risk medical devices<\/strong><br>Implantable, life-sustaining devices or systems that directly replace or permanently support critical body functions.<\/li>\n<\/ul>\n\n\n\n<p>The assigned risk class determines the applicable certification pathway, testing requirements, factory audit obligations, and post-market surveillance duties.<\/p>\n\n\n\n<div style=\"height:25px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Examples of Medical Devices by MFDS Risk Class<\/strong><\/h3>\n\n\n\n<p>The following examples are indicative and may vary depending on device design and intended use.<\/p>\n\n\n<div id=\"tablepress-33-scroll-wrapper\" class=\"tablepress-scroll-wrapper\">\n\n<table id=\"tablepress-33\" class=\"tablepress tablepress-id-33 tablepress-responsive\">\n<tbody class=\"row-striping row-hover\">\n<tr class=\"row-1\">\n\t<td class=\"column-1\"><strong>Class I \u2013 Low Risk Devices<\/strong><\/td><td class=\"column-2\"><strong>Class II \u2013 Medium Risk Devices<\/strong><\/td><td class=\"column-3\"><strong>Class III \u2013 Medium-High Risk Devices<\/strong><\/td><td class=\"column-4\"><strong>Class IV \u2013 High Risk Devices<\/strong><\/td>\n<\/tr>\n<tr class=\"row-2\">\n\t<td class=\"column-1\"><strong>Manual examination or treatment tables<\/strong><br \/>\n(e.g. manually operated examination tables, gynecological tables)<\/td><td class=\"column-2\"><strong>Electronic blood pressure monitors<\/strong><br \/>\n(automatic or semi-automatic sphygmomanometers)<\/td><td class=\"column-3\"><strong>Ventilators (hospital, transport, neonatal)<\/strong><br \/>\n(active respiratory support systems)<\/td><td class=\"column-4\"><strong>Implantable pacemakers<\/strong><br \/>\n(long-term cardiac rhythm management)<\/td>\n<\/tr>\n<tr class=\"row-3\">\n\t<td class=\"column-1\"><strong>Mechanical stethoscopes<\/strong><br \/>\n(used only for acoustic transmission, no signal processing)<\/td><td class=\"column-2\"><strong>Pulse oximeters<\/strong><br \/>\n(non-invasive monitoring of oxygen saturation)<\/td><td class=\"column-3\"><strong>Anesthesia systems and vaporizers<\/strong><br \/>\n(delivery and control of anesthetic gases)<\/td><td class=\"column-4\"><strong>Implantable defibrillators (ICDs)<\/strong><br \/>\n(automatic detection and correction of fatal arrhythmias)<\/td>\n<\/tr>\n<tr class=\"row-4\">\n\t<td class=\"column-1\"><strong>Radiation shielding products<\/strong><br \/>\n(e.g. lead aprons, thyroid shields, radiation gloves)<\/td><td class=\"column-2\"><strong>Medical sterilizers and disinfectors<\/strong><br \/>\n(steam, plasma, UV, or chemical sterilization units)<\/td><td class=\"column-3\"><strong>Hemodialysis machines<\/strong><br \/>\n(extracorporeal blood purification systems)<\/td><td class=\"column-4\"><strong>Cardiopulmonary bypass systems<\/strong><br \/>\n(temporary replacement of heart and lung function during surgery)<\/td>\n<\/tr>\n<tr class=\"row-5\">\n\t<td class=\"column-1\"><strong>Manual blood pressure cuffs<\/strong><br \/>\n(non-electronic, used as accessories)<\/td><td class=\"column-2\"><strong>Diagnostic imaging systems (X-ray, CT, MRI)<\/strong><br \/>\n(general diagnostic imaging equipment)<\/td><td class=\"column-3\"><strong>Defibrillators (external)<\/strong><br \/>\n(active cardiac rhythm correction)<\/td><td class=\"column-4\"><strong>Implantable circulatory assist devices<\/strong><br \/>\n(mechanical support for heart failure patients)<\/td>\n<\/tr>\n<tr class=\"row-6\">\n\t<td class=\"column-1\"><strong>Manual wheelchairs<\/strong><br \/>\n(purely mechanical patient transport devices)<\/td><td class=\"column-2\"><strong>Electric wheelchairs<\/strong><br \/>\n(powered mobility devices for patient transport)<\/td><td class=\"column-3\"><strong>Infant incubators<\/strong><br \/>\n(life-supporting neonatal care systems)<\/td><td class=\"column-4\"><strong>Implantable neurostimulation systems<\/strong><br \/>\n(deep brain, spinal cord, or peripheral nerve stimulators)<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\n<\/div><!-- #tablepress-33 from cache -->\n\n\n\n<div style=\"height:60px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading is-style-border-left-headline\"><strong><strong> <strong>MFDS Certification Process by Risk Class<\/strong><\/strong><\/strong><\/h2>\n\n\n\n<p>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.<\/p>\n\n\n\n<p>In addition to risk classification, MFDS also distinguishes between:<\/p>\n\n\n\n<ul>\n<li>Equivalent products (comparable to already approved devices),<\/li>\n\n\n\n<li>Improved products (modified versions of existing devices), and<\/li>\n\n\n\n<li>New products (novel technologies or indications).<\/li>\n<\/ul>\n\n\n\n<p>This distinction has a direct impact on approval timelines, documentation requirements, and whether clinical evidence is required.<\/p>\n\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Class I Medical Device Notification Process<\/strong><\/h3>\n\n\n\n<p>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.<\/p>\n\n\n\n<p>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.<\/p>\n\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Certification Process for Class II Devices<\/strong><\/h3>\n\n\n\n<p>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.<\/p>\n\n\n\n<p>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.<\/p>\n\n\n\n<p>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.<\/p>\n\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Class III and Class IV Medical Device Approval<\/strong><\/h3>\n\n\n\n<p>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.<\/p>\n\n\n\n<p>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.<\/p>\n\n\n\n<p>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.<\/p>\n\n\n\n<p>In practical terms, MFDS certification can be understood as a <strong>stepwise escalation of regulatory control<\/strong>.<\/p>\n\n\n\n<ul>\n<li><strong>Class I devices<\/strong> are handled through a notification-based system with minimal regulatory burden.<\/li>\n\n\n\n<li><strong>Class II devices<\/strong> require structured certification based on technical review and KGMP compliance, largely managed through MFDS-designated third-party bodies.<\/li>\n\n\n\n<li><strong>Class III and Class IV devices <\/strong>are reviewed directly by MFDS, with deeper technical and clinical assessment.<\/li>\n<\/ul>\n\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading is-style-border-left-headline\"><strong>Korean License Holder Requirement for Foreign Manufacturers<\/strong><\/h2>\n\n\n\n<p>Foreign manufacturers must appoint a Korean license holder (in-country caretaker) to act as the legal applicant and registration holder for MFDS certification.<\/p>\n\n\n\n<p>The Korean license holder is responsible for:<\/p>\n\n\n\n<ul>\n<li>Submitting applications to MFDS<\/li>\n\n\n\n<li>Communicating with authorities and review bodies<\/li>\n\n\n\n<li>Managing Korean labeling and instructions for use<\/li>\n\n\n\n<li>Handling post-market surveillance and incident reporting<\/li>\n\n\n\n<li>Coordinating KGMP audits and renewals<\/li>\n\n\n\n<li>Supporting the import process of products registered in its name<\/li>\n<\/ul>\n\n\n\n<p>Using an independent license holder, rather than a distributor, allows manufacturers to<br>maintain long-term flexibility for their sales and distribution network and control over their<br>Korean registrations.<\/p>\n\n\n\n<p>MPR International can offer such Korean License Holder services that cover all responsibilities are related to this role.<\/p>\n\n\n\n<div style=\"height:30px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading is-style-border-left-headline\"><strong>Korea Good Manufacturing Practice (KGMP) Certification<\/strong><\/h2>\n\n\n\n<p>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.<\/p>\n\n\n\n<div style=\"height:30px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading is-style-border-left-headline\"><strong>MPR <\/strong>Services<\/h2>\n\n\n<section class=\"mpr-theme-services\" style=\"background: url('https:\/\/www.korea-certification.com\/wp-content\/uploads\/leistungen_background_korea_-1.jpg') no-repeat\">\r\n    <div class=\"mpr-theme-services-container\">\r\n        <div class=\"mpr-theme-services-introduction\">\r\n            <h1><span class=\"is-style-h1-headline-content\">Your One-Stop Certification Solution.<\/span><\/h1>\n<p>Our complete package for product certifications for Korea.<\/p>\n        <\/div>\r\n        <div class=\"mpr-theme-services-service-container\">\r\n                            <div class=\"mpr-theme-services-service\">\r\n                    <div class=\"mpr-theme-services-service-icon\">\r\n                        <img decoding=\"async\" class=\"icon\" src=\"https:\/\/www.korea-certification.com\/wp-content\/uploads\/angtragsvorbereitung_2.svg\" alt=\"\">\r\n                    <\/div>\r\n                    <p><strong>Device classification<\/strong> and regulatory strategy<\/p>\n                <\/div>\r\n                            <div class=\"mpr-theme-services-service\">\r\n                    <div class=\"mpr-theme-services-service-icon\">\r\n                        <img decoding=\"async\" class=\"icon\" src=\"https:\/\/www.korea-certification.com\/wp-content\/uploads\/angtragsvorbereitung_1-test-1.png\" alt=\"\">\r\n                    <\/div>\r\n                    <p><strong>Korean license holder<\/strong> services<\/p>\n                <\/div>\r\n                            <div class=\"mpr-theme-services-service\">\r\n                    <div class=\"mpr-theme-services-service-icon\">\r\n                        <img decoding=\"async\" class=\"icon\" src=\"https:\/\/www.korea-certification.com\/wp-content\/uploads\/angtragsvorbereitung.svg\" alt=\"\">\r\n                    <\/div>\r\n                    <p><strong>Technical documentation<\/strong> review<\/p>\n                <\/div>\r\n                            <div class=\"mpr-theme-services-service\">\r\n                    <div class=\"mpr-theme-services-service-icon\">\r\n                        <img decoding=\"async\" class=\"icon\" src=\"https:\/\/www.korea-certification.com\/wp-content\/uploads\/lokal_repraesentatnt.svg\" alt=\"\">\r\n                    <\/div>\r\n                    <p><strong>KGMP preparation<\/strong> and audit support<\/p>\n                <\/div>\r\n                            <div class=\"mpr-theme-services-service\">\r\n                    <div class=\"mpr-theme-services-service-icon\">\r\n                        <img decoding=\"async\" class=\"icon\" src=\"https:\/\/www.korea-certification.com\/wp-content\/uploads\/produkttests_1.svg\" alt=\"\">\r\n                    <\/div>\r\n                    <p><strong>Communication with MFDS<\/strong> and review bodies<\/p>\n                <\/div>\r\n                            <div class=\"mpr-theme-services-service\">\r\n                    <div class=\"mpr-theme-services-service-icon\">\r\n                        <img decoding=\"async\" class=\"icon\" src=\"https:\/\/www.korea-certification.com\/wp-content\/uploads\/icon-regularienaenderung.png\" alt=\"\">\r\n                    <\/div>\r\n                    <p><strong>Post-approval lifecycle<\/strong> and compliance support<\/p>\n                <\/div>\r\n                    <\/div>\r\n    <\/div>\r\n<\/section>\n\n\n<p>Our approach is practical, transparent, and focused on minimizing time-to-market while ensuring full regulatory compliance in Korea.<\/p>\n\n\n<section class=\"mpr-theme-kontakt\">\r\n    <div class=\"mpr-theme-kontakt-inhalt\">\r\n        <h3>Contact Us!<\/h3>\n<p><strong>MPR Korea Certification<\/strong> &#8211; expert consulting and implementation of certification projects worldwide.<\/p>\n<p>&nbsp;<\/p>\n    <\/div>\r\n    <div class=\"mpr-theme-kontakt-teaser\">\r\n        <div class=\"mpr-theme-kontakt-headline-container\">\r\n            <span class=\"mpr-theme-kontakt-headline\">Contact<\/span>\r\n        <\/div>\r\n\r\n        <div class=\"mpr-theme-kontakt-phone-container\">\r\n            <span class=\"mpr-theme-kontakt-phone\">T +49-69-2713769259 (EU)<\/span>\r\n        <\/div>\r\n\r\n        <div class=\"mpr-theme-kontakt-phone-container phone-2\">\r\n            <span class=\"mpr-theme-kontakt-phone\">T +1-773-654-2673 (US)<\/span>\r\n        <\/div>\r\n\r\n        <div class=\"mpr-theme-kontakt-mail-container\">\r\n            <a href=\"mailto:info@korea-certification.com\"><span class=\"mpr-theme-kontakt-mail\">info@korea-certification.com<\/span><\/a>\r\n        <\/div>\r\n    <\/div>\r\n<\/section>\n\n\n<h2 class=\"wp-block-heading is-style-border-left-headline\"><strong>MFDS Certification <\/strong>FAQ<\/h2>\n\n\n<section class=\"mpr-theme-faq-accordion\">\r\n            <div class=\"mpr-theme-faq-accordion-headline\">\r\n            <div class=\"mpr-theme-faq-accordion-headline-content\">\r\n                <span>Do foreign manufacturers need a Korean subsidiary for MFDS approval?<\/span>\r\n            <\/div>\r\n        <\/div>\r\n        <div class=\"mpr-theme-faq-accordion-content-block\">\r\n            <div class=\"mpr-theme-faq-accordion-content\">\r\n                <div class=\"mpr-theme-faq-accordion-text\">\r\n                    <p>No. A Korean license holder is required, but this can be an independent third party.<\/p>\n                <\/div>\r\n            <\/div>\r\n        <\/div>\r\n            <div class=\"mpr-theme-faq-accordion-headline\">\r\n            <div class=\"mpr-theme-faq-accordion-headline-content\">\r\n                <span>Is CE or FDA approval required for MFDS certification?<\/span>\r\n            <\/div>\r\n        <\/div>\r\n        <div class=\"mpr-theme-faq-accordion-content-block\">\r\n            <div class=\"mpr-theme-faq-accordion-content\">\r\n                <div class=\"mpr-theme-faq-accordion-text\">\r\n                    <p>No. Prior approval in the country of origin is not mandatory, though it can support the application.<\/p>\n                <\/div>\r\n            <\/div>\r\n        <\/div>\r\n            <div class=\"mpr-theme-faq-accordion-headline\">\r\n            <div class=\"mpr-theme-faq-accordion-headline-content\">\r\n                <span>Is KGMP mandatory for all medical devices?<\/span>\r\n            <\/div>\r\n        <\/div>\r\n        <div class=\"mpr-theme-faq-accordion-content-block\">\r\n            <div class=\"mpr-theme-faq-accordion-content\">\r\n                <div class=\"mpr-theme-faq-accordion-text\">\r\n                    <p>KGMP is mandatory for Class II, III, and IV devices.<\/p>\n                <\/div>\r\n            <\/div>\r\n        <\/div>\r\n            <div class=\"mpr-theme-faq-accordion-headline\">\r\n            <div class=\"mpr-theme-faq-accordion-headline-content\">\r\n                <span>Are clinical trials always required in Korea?<\/span>\r\n            <\/div>\r\n        <\/div>\r\n        <div class=\"mpr-theme-faq-accordion-content-block\">\r\n            <div class=\"mpr-theme-faq-accordion-content\">\r\n                <div class=\"mpr-theme-faq-accordion-text\">\r\n                    <p>No. Many devices can be approved based on equivalence and technical documentation.<\/p>\n                <\/div>\r\n            <\/div>\r\n        <\/div>\r\n            <div class=\"mpr-theme-faq-accordion-headline\">\r\n            <div class=\"mpr-theme-faq-accordion-headline-content\">\r\n                <span>How long does MFDS certification take?<\/span>\r\n            <\/div>\r\n        <\/div>\r\n        <div class=\"mpr-theme-faq-accordion-content-block\">\r\n            <div class=\"mpr-theme-faq-accordion-content\">\r\n                <div class=\"mpr-theme-faq-accordion-text\">\r\n                    <p>Depending on the risk class, from a few weeks (Class I) to several months (Class III\u2013IV).<\/p>\n                <\/div>\r\n            <\/div>\r\n        <\/div>\r\n            <div class=\"mpr-theme-faq-accordion-headline\">\r\n            <div class=\"mpr-theme-faq-accordion-headline-content\">\r\n                <span>Can MFDS approvals be transferred to another Korean representative?<\/span>\r\n            <\/div>\r\n        <\/div>\r\n        <div class=\"mpr-theme-faq-accordion-content-block\">\r\n            <div class=\"mpr-theme-faq-accordion-content\">\r\n                <div class=\"mpr-theme-faq-accordion-text\">\r\n                    <p>Yes, but this requires formal MFDS notification and approval by the previous representative.<\/p>\n                <\/div>\r\n            <\/div>\r\n        <\/div>\r\n    <\/section>\n\n\n<p class=\"has-small-font-size\"><\/p>\n\n\n\n<h2 class=\"wp-block-heading is-style-border-left-headline\"><strong>Client Testimonials<\/strong><\/h2>\n\n\n\n<p class=\"has-small-font-size\">Please enable cookies to enable embedded YouTube videos. For privacy-related details on data exchange through use of the videos as well as changeable cookie settings, please see the <a href=\"https:\/\/www.korea-certification.com\/en\/privacy-policy\/\">privacy policy page<\/a>.<\/p>\n\n\n\r\n<section class=\"mpr-theme-video\">\r\n    <div class=\"mpr-theme-video-content-container\">\r\n         <div class=\"brlbs-cmpnt-container brlbs-cmpnt-content-blocker brlbs-cmpnt-with-individual-styles\" data-borlabs-cookie-content-blocker-id=\"default\" data-borlabs-cookie-content=\"PGlmcmFtZSB0aXRsZT0iSGVhciBGcm9tIE91ciBDbGllbnRzIOKAkyBNUFIgQ3VzdG9tZXIgRmVlZGJhY2sgQ29tcGlsYXRpb24iIHdpZHRoPSI2NDAiIGhlaWdodD0iMzYwIiBzcmM9Imh0dHBzOi8vd3d3LnlvdXR1YmUuY29tL2VtYmVkL2RETklENXM2YnZvP2ZlYXR1cmU9b2VtYmVkIiBmcmFtZWJvcmRlcj0iMCIgYWxsb3c9ImFjY2VsZXJvbWV0ZXI7IGF1dG9wbGF5OyBjbGlwYm9hcmQtd3JpdGU7IGVuY3J5cHRlZC1tZWRpYTsgZ3lyb3Njb3BlOyBwaWN0dXJlLWluLXBpY3R1cmU7IHdlYi1zaGFyZSIgcmVmZXJyZXJwb2xpY3k9InN0cmljdC1vcmlnaW4td2hlbi1jcm9zcy1vcmlnaW4iIGFsbG93ZnVsbHNjcmVlbj48L2lmcmFtZT4=\"><div class=\"brlbs-cmpnt-cb-preset-a\"> <p class=\"brlbs-cmpnt-cb-description\">You are currently viewing a placeholder content from <strong>Default<\/strong>. To access the actual content, click the button below. Please note that doing so will share data with third-party providers.<\/p> <div class=\"brlbs-cmpnt-cb-buttons\"> <a class=\"brlbs-cmpnt-cb-btn\" href=\"#\" data-borlabs-cookie-unblock role=\"button\">Unblock content<\/a> <a class=\"brlbs-cmpnt-cb-btn\" href=\"#\" data-borlabs-cookie-accept-service role=\"button\" style=\"display: none\">Accept required service and unblock content<\/a> <\/div> <a class=\"brlbs-cmpnt-cb-provider-toggle\" href=\"#\" data-borlabs-cookie-show-provider-information role=\"button\">More Information<\/a> <\/div><\/div>    <\/div>\r\n\r\n    <div class=\"mpr-theme-video-more\">\r\n        <a class=\"video-button\" href=\"https:\/\/www.youtube.com\/@internationalproductcertif8295\"\r\n           target=\"_blank\">More Videos<\/a>\r\n    <\/div>\r\n\r\n<\/section>\r\n\n\n<section class=\"mpr-kundenstimmen-slider\">\r\n    <div class=\"mpr-kundenstimmen-slider-content  center\">\r\n                    <div class=\"mpr-theme-kundenstimmen-sldier-slide\">\r\n                <p class=\"mpr-theme-kundenstimmen-slider-headline\">Carlo F., Test Manager, Maserati S.p.A. (FCA Group)<\/p>\r\n                <p class=\"mpr-theme-kundenstimmen-slider-inhalt\">\u201eMPR International has been able to provide an excellent service. Availability, competence, kindness and respect of the agreed deadlines were perfect. We were able to finish the process even before the deadline. Their support regarding the official tests and the preparation for the audit was great. If help is necessary in the future, it would be a pleasure fur us to work with MPR International again.\u201d<\/p>\r\n            <\/div>\r\n                    <div class=\"mpr-theme-kundenstimmen-sldier-slide\">\r\n                <p class=\"mpr-theme-kundenstimmen-slider-headline\">Jens L., Head of Homologation, Bugatti Engineering GmbH<\/p>\r\n                <p class=\"mpr-theme-kundenstimmen-slider-inhalt\">\u201eWe had very critical deadlines for the certification of our Bugatti Veyron. Fortunately, we found MPR International and were competently supported, both in terms of the vehicle-certification and the certification of our suppliers. We were able to certify our car models in time. Thank you for this excellent service!\u201d<br \/>\r\n<\/p>\r\n            <\/div>\r\n                    <div class=\"mpr-theme-kundenstimmen-sldier-slide\">\r\n                <p class=\"mpr-theme-kundenstimmen-slider-headline\">Claudia S., Staff Project Manager, Tesla Motors, Inc.<\/p>\r\n                <p class=\"mpr-theme-kundenstimmen-slider-inhalt\">\u201eMPR International competently supported us in obtain our product certification. We have been very happy with all of the aspects of their pre-audit, complete service package, translation and ongoing compliance updates. We feel that MPR International is an excellent service provider, and gladly recommend them to others who are looking for assistance with product certification.\u201d<br \/>\r\n<\/p>\r\n            <\/div>\r\n                    <div class=\"mpr-theme-kundenstimmen-sldier-slide\">\r\n                <p class=\"mpr-theme-kundenstimmen-slider-headline\">Daniel W., Program Quality Leader, Faurecia<\/p>\r\n                <p class=\"mpr-theme-kundenstimmen-slider-inhalt\">\u201cWe have certified in recent years numerous plants with  MPR International. Due to their resources and good contacts, the certifications could be conducted timely, its high action and reaction speed distinguish MPR International. We are very pleased and appreciate the fair price and the wide range of offered services. There were no costs subsequently charged, making budgeting easy. By these means, thanks again.\u201d<\/p>\r\n            <\/div>\r\n            <\/div>\r\n<\/section>\n\n<section class=\"mpr-theme-other-topics\">\r\n    <div class=\"mpr-theme-teaser-other-topics-content-container\">\r\n                    <div class=\"mpr-theme-other-topics-content\" style=\"background: url('') no-repeat\"><a href=\"https:\/\/www.korea-certification.com\/en\/kc-emc\/kc-emc-certification\/\">\r\n                    <div class=\"mpr-theme-other-topics-content-background\">\r\n                        <div class=\"mpr-theme-other-topics-content-container-headline\">\r\n                            <span class=\"mpr-theme-other-topics-headline\">KC EMC Certification<\/span>\r\n                        <\/div>\r\n                        <div class=\"mpr-theme-other-topics-content-container-subline\">\r\n                            <span class=\"mpr-theme-teaser-service-subline\">Read more&#8230;<\/span><br>\r\n                        <\/div>\r\n                    <\/div>\r\n                <\/a><\/div>\r\n                    <div class=\"mpr-theme-other-topics-content\" style=\"background: url('') no-repeat\"><a href=\"https:\/\/www.korea-certification.com\/en\/kcs\/kcs-ex-certification-for-explosion-proof-components\/\">\r\n                    <div class=\"mpr-theme-other-topics-content-background\">\r\n                        <div class=\"mpr-theme-other-topics-content-container-headline\">\r\n                            <span class=\"mpr-theme-other-topics-headline\">KCs Ex Certification for Ex-Products<\/span>\r\n                        <\/div>\r\n                        <div class=\"mpr-theme-other-topics-content-container-subline\">\r\n                            <span class=\"mpr-theme-teaser-service-subline\">Read more&#8230;<\/span><br>\r\n                        <\/div>\r\n                    <\/div>\r\n                <\/a><\/div>\r\n                    <div class=\"mpr-theme-other-topics-content\" style=\"background: url('') no-repeat\"><a href=\"https:\/\/www.korea-certification.com\/en\/kgs-factory-registration\/\">\r\n                    <div class=\"mpr-theme-other-topics-content-background\">\r\n                        <div class=\"mpr-theme-other-topics-content-container-headline\">\r\n                            <span class=\"mpr-theme-other-topics-headline\">KGS Factory Registration<\/span>\r\n                        <\/div>\r\n                        <div class=\"mpr-theme-other-topics-content-container-subline\">\r\n                            <span class=\"mpr-theme-teaser-service-subline\">Read more&#8230;<\/span><br>\r\n                        <\/div>\r\n                    <\/div>\r\n                <\/a><\/div>\r\n                    <div class=\"mpr-theme-other-topics-content\" style=\"background: url('') no-repeat\"><a href=\"https:\/\/www.mpr-international.com\/en\/\">\r\n                    <div class=\"mpr-theme-other-topics-content-background\">\r\n                        <div class=\"mpr-theme-other-topics-content-container-headline\">\r\n                            <span class=\"mpr-theme-other-topics-headline\">Countries<\/span>\r\n                        <\/div>\r\n                        <div class=\"mpr-theme-other-topics-content-container-subline\">\r\n                            <span class=\"mpr-theme-teaser-service-subline\">Read more&#8230;<\/span><br>\r\n                        <\/div>\r\n                    <\/div>\r\n                <\/a><\/div>\r\n            <\/div>\r\n\r\n<\/section>\r\n\n\n<section class=\"mpr-theme-teaser-service\">\r\n    <div class=\"mpr-theme-teaser-service-content-container\">\r\n                    <div class=\"mpr-theme-teaser-service-content\"><a href=\"https:\/\/www.korea-certification.com\/en\/company\/video-channel\/\">\r\n                    <div class=\"mpr-theme-teaser-service-content-container-headline\">\r\n                        <span class=\"mpr-theme-teaser-service-headline\">Videos<\/span>\r\n                    <\/div>\r\n\r\n                    <div class=\"mpr-theme-teaser-service-content-container-subline\">\r\n                        <span class=\"mpr-theme-teaser-service-subline\">All Videos <\/span><br>\r\n                        <span class=\"mpr-theme-teaser-service-subline-2\">MPR Channel<\/span>\r\n                    <\/div>\r\n\r\n                    <div class=\"mpr-theme-teaser-service-content-container-icon\">\r\n                        <img decoding=\"async\" class=\"icon\" src=\"https:\/\/www.korea-certification.com\/wp-content\/uploads\/teaser-service-play-button.png\" alt=\"\">\r\n                    <\/div>\r\n                <\/a><\/div>\r\n                    <div class=\"mpr-theme-teaser-service-content\"><a href=\"https:\/\/www.korea-certification.com\/en\/korea-certification-booklet\/\">\r\n                    <div class=\"mpr-theme-teaser-service-content-container-headline\">\r\n                        <span class=\"mpr-theme-teaser-service-headline\">Booklet<\/span>\r\n                    <\/div>\r\n\r\n                    <div class=\"mpr-theme-teaser-service-content-container-subline\">\r\n                        <span class=\"mpr-theme-teaser-service-subline\">Free<\/span><br>\r\n                        <span class=\"mpr-theme-teaser-service-subline-2\">Download<\/span>\r\n                    <\/div>\r\n\r\n                    <div class=\"mpr-theme-teaser-service-content-container-icon\">\r\n                        <img decoding=\"async\" class=\"icon\" src=\"https:\/\/www.korea-certification.com\/wp-content\/uploads\/teaser-service-download-icon.png\" alt=\"\">\r\n                    <\/div>\r\n                <\/a><\/div>\r\n                    <div class=\"mpr-theme-teaser-service-content\"><a href=\"https:\/\/www.korea-certification.com\/en\/company\/media-and-publications\/\">\r\n                    <div class=\"mpr-theme-teaser-service-content-container-headline\">\r\n                        <span class=\"mpr-theme-teaser-service-headline\">Media &#038; Publications<\/span>\r\n                    <\/div>\r\n\r\n                    <div class=\"mpr-theme-teaser-service-content-container-subline\">\r\n                        <span class=\"mpr-theme-teaser-service-subline\">Publications<\/span><br>\r\n                        <span class=\"mpr-theme-teaser-service-subline-2\"><\/span>\r\n                    <\/div>\r\n\r\n                    <div class=\"mpr-theme-teaser-service-content-container-icon\">\r\n                        <img decoding=\"async\" class=\"icon\" src=\"https:\/\/www.korea-certification.com\/wp-content\/uploads\/teaser-service-publications.png\" alt=\"\">\r\n                    <\/div>\r\n                <\/a><\/div>\r\n                    <div class=\"mpr-theme-teaser-service-content\"><a href=\"https:\/\/www.korea-certification.com\/en\/company\/contact\/\">\r\n                    <div class=\"mpr-theme-teaser-service-content-container-headline\">\r\n                        <span class=\"mpr-theme-teaser-service-headline\">Contact<\/span>\r\n                    <\/div>\r\n\r\n                    <div class=\"mpr-theme-teaser-service-content-container-subline\">\r\n                        <span class=\"mpr-theme-teaser-service-subline\">T + 49-69-2713769259<\/span><br>\r\n                        <span class=\"mpr-theme-teaser-service-subline-2\">Send Email<\/span>\r\n                    <\/div>\r\n\r\n                    <div class=\"mpr-theme-teaser-service-content-container-icon\">\r\n                        <img decoding=\"async\" class=\"icon\" src=\"https:\/\/www.korea-certification.com\/wp-content\/uploads\/teaser-service-contact-icon.png\" alt=\"\">\r\n                    <\/div>\r\n                <\/a><\/div>\r\n            <\/div>\r\n\r\n<\/section>\r\n","protected":false},"excerpt":{"rendered":"<p>your one-stop certification solution! 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 [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":8844,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v21.8 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>MFDS Certification for Medical Devices in South Korea<\/title>\n<meta name=\"description\" content=\"Overview of MFDS certification for medical devices for the Korean market.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.korea-certification.com\/en\/mfds-certification-en\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"MFDS Certification for Medical Devices in South Korea\" \/>\n<meta property=\"og:description\" content=\"Overview of MFDS certification for medical devices for the Korean market.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.korea-certification.com\/en\/mfds-certification-en\/\" \/>\n<meta property=\"og:site_name\" content=\"MPR Korea Certification\" \/>\n<meta property=\"article:modified_time\" content=\"2026-02-26T15:42:53+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.korea-certification.com\/wp-content\/uploads\/teaser-awards-small.png\" \/>\n\t<meta property=\"og:image:width\" content=\"1920\" \/>\n\t<meta property=\"og:image:height\" content=\"404\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"9 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.korea-certification.com\/en\/mfds-certification-en\/\",\"url\":\"https:\/\/www.korea-certification.com\/en\/mfds-certification-en\/\",\"name\":\"MFDS Certification for Medical Devices in South Korea\",\"isPartOf\":{\"@id\":\"https:\/\/www.korea-certification.com\/en\/#website\"},\"datePublished\":\"2026-02-16T15:13:49+00:00\",\"dateModified\":\"2026-02-26T15:42:53+00:00\",\"description\":\"Overview of MFDS certification for medical devices for the Korean market.\",\"breadcrumb\":{\"@id\":\"https:\/\/www.korea-certification.com\/en\/mfds-certification-en\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.korea-certification.com\/en\/mfds-certification-en\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/www.korea-certification.com\/en\/mfds-certification-en\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Startseite\",\"item\":\"https:\/\/www.korea-certification.com\/en\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"MFDS Certification EN\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.korea-certification.com\/en\/#website\",\"url\":\"https:\/\/www.korea-certification.com\/en\/\",\"name\":\"MPR Korea Certification\",\"description\":\"Ihr Experte f\u00fcr Korea-Zertifizierungen\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/www.korea-certification.com\/en\/?s={search_term_string}\"},\"query-input\":\"required name=search_term_string\"}],\"inLanguage\":\"en-US\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"MFDS Certification for Medical Devices in South Korea","description":"Overview of MFDS certification for medical devices for the Korean market.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.korea-certification.com\/en\/mfds-certification-en\/","og_locale":"en_US","og_type":"article","og_title":"MFDS Certification for Medical Devices in South Korea","og_description":"Overview of MFDS certification for medical devices for the Korean market.","og_url":"https:\/\/www.korea-certification.com\/en\/mfds-certification-en\/","og_site_name":"MPR Korea Certification","article_modified_time":"2026-02-26T15:42:53+00:00","og_image":[{"width":1920,"height":404,"url":"https:\/\/www.korea-certification.com\/wp-content\/uploads\/teaser-awards-small.png","type":"image\/png"}],"twitter_card":"summary_large_image","twitter_misc":{"Est. reading time":"9 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/www.korea-certification.com\/en\/mfds-certification-en\/","url":"https:\/\/www.korea-certification.com\/en\/mfds-certification-en\/","name":"MFDS Certification for Medical Devices in South Korea","isPartOf":{"@id":"https:\/\/www.korea-certification.com\/en\/#website"},"datePublished":"2026-02-16T15:13:49+00:00","dateModified":"2026-02-26T15:42:53+00:00","description":"Overview of MFDS certification for medical devices for the Korean market.","breadcrumb":{"@id":"https:\/\/www.korea-certification.com\/en\/mfds-certification-en\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.korea-certification.com\/en\/mfds-certification-en\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/www.korea-certification.com\/en\/mfds-certification-en\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Startseite","item":"https:\/\/www.korea-certification.com\/en\/"},{"@type":"ListItem","position":2,"name":"MFDS Certification EN"}]},{"@type":"WebSite","@id":"https:\/\/www.korea-certification.com\/en\/#website","url":"https:\/\/www.korea-certification.com\/en\/","name":"MPR Korea Certification","description":"Ihr Experte f\u00fcr Korea-Zertifizierungen","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.korea-certification.com\/en\/?s={search_term_string}"},"query-input":"required name=search_term_string"}],"inLanguage":"en-US"}]}},"_links":{"self":[{"href":"https:\/\/www.korea-certification.com\/en\/wp-json\/wp\/v2\/pages\/24868"}],"collection":[{"href":"https:\/\/www.korea-certification.com\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.korea-certification.com\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.korea-certification.com\/en\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.korea-certification.com\/en\/wp-json\/wp\/v2\/comments?post=24868"}],"version-history":[{"count":12,"href":"https:\/\/www.korea-certification.com\/en\/wp-json\/wp\/v2\/pages\/24868\/revisions"}],"predecessor-version":[{"id":24979,"href":"https:\/\/www.korea-certification.com\/en\/wp-json\/wp\/v2\/pages\/24868\/revisions\/24979"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.korea-certification.com\/en\/wp-json\/wp\/v2\/media\/8844"}],"wp:attachment":[{"href":"https:\/\/www.korea-certification.com\/en\/wp-json\/wp\/v2\/media?parent=24868"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}