Medical Device Distribution Quality Management in Korea

Background Recently Korean Ministry of Food and Drug Safety (MFDS previously called KFDA) published its quality management standard

Background

Recently Korean Ministry of Food and Drug Safety (MFDS previously called KFDA) published its quality management standard for distributors operating in South Korea. Is your distributor ready ?

After strengthening its regulation for license holders and require them to appoint a dedicated Quality Manager (effective since July 2014), MFDS is now regulating the distribution more precisely.

This new regulation about medical device distribution will take effect starting from Jan. 1st of next year.

We prepared a guide to keep you informed and you can download it by clicking here:

Medical Device Distribution Management Standard

The original publication can be found here.

 


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.