South Korea - Registration of Medical Devices (MFDS)
Ensure product safety and quality with MFDS certification for medical devices with TÜV Rheinland
Introduction
Medical devices intended for sale in Korea must comply with regulations established by the Korean ‘Ministry of Food and Drugs Safety’ (MFDS, formerly known as KFDA). The MFDS protects and promotes the public health through thorough safety control of food, pharmaceuticals, cosmetics, herbal medicines and medical devices in South Korea. The MFDS requires the submission of technical documents for the certification and approval of medical devices. Class I and most Class II devices are certified by the medical device information and technology assistance center (MDITAC). Several Class II (new) devices and Class III / IV devices are approved by the MFDS.
TÜV Rheinland can handle your application for certification and conduct inspections of your products. Partnering with us means short lead times and benefitting from our established working relations with local authorities. Ask how we can help you efficiently gain MFDS certification for your medical devices!
TÜV Rheinland can handle your application for certification and conduct inspections of your products. Partnering with us means short lead times and benefitting from our established working relations with local authorities. Ask how we can help you efficiently gain MFDS certification for your medical devices!
Product scope
Medical devices (except IVD) are categorized in a four classes
system, based on potential risk to human health
Class I: Little Risk
Class II: Low Risk
Class III: Moderate Risk
Class IV: High Risk
Class I: Little Risk
Class II: Low Risk
Class III: Moderate Risk
Class IV: High Risk
Countries:
South Korea
Product categories:
Medical Devices
Technical aspects:
EMC
Hygienic / Food Contact
Product/Packaging Labeling
Safety
Regions:
Asia
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