Kobridge Director, Nicolas Clary, will be participating in a free webinar hosted by LNE/G-MED the French Notified Body. The topics covered in those webinar are mostly aimed at introducing foreign regulations. Korean medical devices regulations will be covered on the same slot as Japan. Each slot is 45 minutes long. The date of the webinar is…
On April 2nd 2014, Ministry of Food and Drug Safety published on their website the second revision of their Korean GMP guideline. The analysis of the changes is currently being made and we will soon be able to provide a gap analysis as well as an English version of the document. Changes include for instance…
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…
Segmentation of products for Korea MFDS A new segmentation for 4 products including absorbable coronary stent was issued by MFDS recently in order to add some clarity. (from MFDS on Jan. 14, 2014) The following products are concerned: A09230.02 Artificial Kidney Filter System Class 3 A79110.02 Medication Dosage Regulator Class 3 B03300.15 Absorbable Coronary Stent…
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…