Finally available. Our translation of the Korean GMP Revision 2 in English is ready. The document was validated and is now ready for review. The main modifications are summarized below: Removed GMP inspection for class 1, but tightened for class 2, in the past, for class 2 only document inspection required, but since Jan 2014 it has been changed to site…
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…