EU MFDS

MFDS to strengthen relationship with Polish and Czech medical device and medicine agencies

Korean Ministry of Food and Drug Safety MFDS has announced that in order to expand European market of

Korean Ministry of Food and Drug Safety MFDS has announced that in order to expand European market of medical devices they are holding a working meeting at the MFDS office with Polish and Czech pharmaceutical and medical equipment registration office.

This working meeting was arranged to follow up with high level officer meeting in 2013 and to discuss practical solutions to memorandum of understanding written for Polish and Czech pharmaceutical and medical equipment registration office written in 2013.

The main achievements include 1) exchanging clinical trial information, 2) understanding management system after market release and sharing safety information, 3) increasing participation of events run by Korean offices for pharmaceutical and medical equipment, and 4) collaboration on medical product researches.

For pharmaceutical sector as an example, the information that will be exchanged will include Czech and Polish clinical trial pharmaceutical products’ import and management system, clinical trial participants and management. This will be shared to support domestic pharmaceutical companies in their effort to run various clinical trials in Poland and Czech Republic

This meeting will also look to strengthen cooperation in Poland and Czech Republic to support Korean pharmaceuticals in their utilization of equipment and infrastructure.

In addition, ‘personalized genome medicine’ and other topics will be discussed for future cooperation.

In the case of medical devices, strengthening medical equipment follow-up management services will be shared and analyzed to aid domestic industries in their effort to expand their impact.

MFDS is encouraging Czech and Polish pharmaceutical and medical equipment registration office and industries to participate in additional future meetings such as ‘Global BioConference’ and ‘Domestic Medical Equipment Forum’

MFDS is optimistic about this meeting and is hoping that the meeting will result in strengthening safety management and looking to expand domestic pharmaceutical companies work in Europe.

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.