KC Certification-Medical Devices | MFDS
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KC Certification-Medical Devices | MFDS Medical devices, including beauty products, are subject to reporting or permitting requirements from the Ministry of Food and Drug Safety of Korea (MFDS) and the National Institute of Medical Device Safety Information (NIDS) for individuals or entities intending to manufacture, import, or sell such products before engaging in any trading activities. Depending on the purpose of use and degree of risk, a medical device can be rated from Class 1 through Class 4. A manufacturer, importer, or distributor may sell products only after a GMP inspection for company license and product approval. An overseas manufacturer can file an application through a domestic importer or a proper local agency, and a manufacturer, importer, and agency can get a license after confirming no quality issues during the GMP inspection. ▮ Classification of medical devices Depending on the purpose of use and degree of potential risk during use, a medical device can be r