Manufacturers and suppliers who wish to sell or import medical devices in South Korea must first be approved by Korea’s Ministry of Food and Drug Safety (MFDS, formerly known as the KFDA). Companies not located in South Korea must appoint an importer license holder located in South Korea, who legally represents the company in all dealings with the MFDS. License holders are also subject to a good manufacturing practices audit, which generally follows the requirements of ISO 13485.
Medical devices in South Korea are assigned to one of four classes, according to the level of risk. Except for Class I devices, all medical devices require approval from the MFDS. For Class II, III and IV devices involving new types of technology or a new intended use, the MFDS requires the submission of a technical file and clinical studies as the basis for a Safety and Efficacy Review (SER). The MFDS reviews this documentation for Class III and Class IV devices, while MFDS approved third-parties can review technical documentation for Class II devices. Test reports prepared by MFDS approved testing laboratories on the function, safety and efficacy of the medical device must also be submitted.
TÜV SÜD has operated in Korea since 1992, and maintains offices in Seoul and Busan, as well as a testing laboratory in Guro, Seoul. TÜV SÜD Korea is approved by the MFDS as a third party authorised to conduct technical file reviews for all product categories in Class II. Medical device experts at TÜV SÜD Korea also have extensive knowledge about current and prospective regulations affecting medical device access to the Korean market, and maintain effective communications with national regulators and representatives of international manufacturers.
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