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 the removal of KGMP inspection for class 1 products (this was already notified at the end of last year).
The original notification and the link to the document can be found here (in Korean).
If you wish to sell in South Korea you can contact us for a preliminary discussion. See also our services for the registration of medical devices in South Korea.
