Issues and updates related to the South Korean market. Notifications from the MFDS, market trends, public consultations, standards updates
In a very similar way as US FDA addressed this topic, South Korean MFDS has announced measures to distinguish mobile medical devices from more fitness related application or devices. The original public consultation is posted here. Comments from the public can be submitted until April 7, 2014. For instance, heart rate monitors and pulse rate…
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…
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: 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…
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…
Public consultation about IEC 60601-1 third Edition implementation in South Korea The current dates for the implementation of IEC 60601-1 3rd Ed. (electrical safety) are as follow: June 1, 2014, all Class 3 and Class 4. Class 2 June 1, 2015 Class 1 June 1, 2016 However, there is a public consultation in-progress now. The…
It’s not only a name change in fact. Of course the Korean FDA became The MFDS (Ministry of Food and Drug Safety), but beyond that the agency has been promoted to a ministry level.
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,…
Starting here is a serie of posts related to Korean Regulation, the first one being about South Korea KGMP inspection requirements which is equivalent of the US Good Manufacturing Practice. Quality system regulations (KGMP) All Medical Devices are required to be manufactured under GMP. Premarket GMP audit is mandatory for all class II, III…