In-Vitro Diagnostic

korea medical device regulations update 2015-01-14

Reclassification and re-categorization of medical devices The Ministry of Food and Drug Safety (MFDS) is publishing Korea medical

Reclassification and re-categorization of medical devices

The Ministry of Food and Drug Safety (MFDS) is publishing Korea medical device regulations update on a regular basis. It recently published a notice to inform that a reclassification and re-categorization of products would occur.

  1. Reclassification of 244 products previously known as in vitro radio-pharmaceuticals to medical devices
    1.  guideline was also published to help updating existing licenses
  2. Change in the categorization of products
    1. Create new sub-categories for new products
    2. Clarification in the definition of products
    3. Class adjustment based on international classification
    4. Deletion of product categories

For instance regarding the re-categorization of products:

  • Sub-category created for: ultrasound gel, breast milk composition analyser (3 more products listed)
  • Break down category “drill hand-piece, surgical, electrically-powered” as single use and reusable ¬†(17 more products listed)
  • Pulse oximeter is classified as medical device and paraffin bath as non-medical device (258 more products listed)
  • Endoscopic forceps used for heart and central nervous system reclassified from class 1 to 4
  • Cutting dental casts withdrawn from medical device

The details can be found on MFDS website: www.mfds.go.kr

 


 

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.