Overview of clinical trial regulation in Korea

In the following pictures we added an overview of the clinical trial regulation in Korea. It gives an

In the following pictures we added an overview of the clinical trial regulation in Korea. It gives an overview of the process for clinical study in Korea.

We recently had lots of discussions on how to conduct studies we thought a brief reminder would be welcome.

The first table is about the process when investigator and sponsor are distinct.

 

clinical study overview

 

The next table is describing the process when investigator and sponsor are the same.

 

Investigator overview

 

 


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.

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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.