Issues and updates related to the South Korean market. Notifications from the MFDS, market trends, public consultations, standards updates

How to search for Korean Standards

How to search for Korean Standards Following a request from one of our subscribers, here is a brief video to quickly find information about Korean Standards in English. Find out if an English version exists and if the Korean version is identical or modified. The video is on our recently created Youtube channel: http://youtu.be/T7V3vxWIQHs The…

Pressure Pump Mediacl Device

medical device registration in korea – appointing medical device quality manager for class 1 products

Medical device registration in Korea: appointing medical device quality manager for class 1 products In case of class 1 medical devices, the voluntary system that allow manufacturers/importers to manage quality control internally was adopted. However, the current medical device act does not require the manufacturers/importers that are seeking licensing to employ the medical device quality…

korean labeling requirements

Korean labeling requirements: One of our subscribers raised the point of labeling requirements specifically asking if it was necessary to include the “manufactured by…” and “Made in …” on the labels. Let’s review below what are the requirements including this one so that we get the overall picture. On the device label product name model…

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inspection of dealers or rental agencies by inspection agencies designated by MFDS

inspection of dealers or rental agencies by inspection agencies designated by MFDS Korea In the past, when purchasing a medical device from medical institutions, the medical device dealers or rental agencies, were required to obtain qualifying inspection from the manufacturer or importer of the said medical devices regarding the manufacturing and quality control standards of…

Technical document review in South Korea

Technical document review A technical document review is a general “technical document review” (TDR) for those products that are basically the same as an already approved product, whereas a “safety and efficacy review” (SER) is required for devices unlike those currently available on the market – falling under new structure, new performance, new intended use,…