KGMP guideline revision

The Korean GMP (KGMP) guideline has been updated earlier this year (2016) and even if it was only provided in Korean we prepared a translated version in English.

More details were provided in the guideline and the case of in vitro diagnostic equipment was considered since those were reclassified as medical devices.

In addition to this, companies willing to register their product in Korea should also keep in mind that the process has changed recently.

As a consequence, the KGMP certificate must be obtained first (site audit) and then the manufacturers can apply for their product licenses.

The link to the guideline is here or can be also downloaded from our resource page.

 

About nicolas

My name is Nicolas Clary, I'm the founder and CEO of Kobridge Consulting Ltd. in 2006 when I met my wife in Korea I had no idea it would lead me to this. At that time I was already a consultant and regulatory expert for Medtech companies. I was also an auditor for the French Notified Body LNE. In 2007 I decided to move to Korea to establish a consulting business there. At first I was like most my actual clients : completely lost. It took me a lot of time to understand all the regulatory processes in Korea and fortunately I was lucky enough to find the right people. I am much better now at understanding my clients' needs because I've been in their shoes before. I usually say that I'm a translator. Understanding different regulations helps to explain certain requirements (here Korea vs Europe or US). I can also translate the needs of regulatory professionals to sales professionals and vice versa.