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…