implant

Implants traceability requirements

Important reminder: the Ministry of Food and Drug Safety MFDS has expanded its list of implants subject to

Important reminder: the Ministry of Food and Drug Safety MFDS has expanded its list of implants subject to tracking.

The implants traceability requirements were already defined.

Until Dec. 31, 2014 there were only 28 products in that category and now the list expanded to 52.
Among the 24 new products in the list: artificial blood vessels, joints…
Since November 2014, importers have obligation to report on a monthly basis the status of the device.
Templates, examples and presentation are provided by MFDS (in Korea).

 


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.

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.