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…

Korean KGMP guideline in English

Korean KGMP guideline in English Any idea how many times we’ve been asked by our clients or subscribers whether an English version of the Korean KGMP guideline was available ? Countless times ! Following our policy of transparency we’ve prepared a translation and reviewed several times to make sure that people familiar with other regulations…

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…

Biocompatibility standards in South Korea

Biocompatibility standards in South Korea under revision MFDS is revising its 「General Standard Specification regarding Biocompatibility of Medical Devices」 (Ministry of Food and Drug Safety Notice No. 2013-64, 2013.4.5) in part, and gathering consensus from the people. See below the purpose, reasons for revision, and key details as following in accordance with 「Administrative Procedures Act」…

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…