Segmentation of products for Korea MFDS

A new segmentation for 4 products including absorbable coronary stent was issued by MFDS recently in order to add some clarity. (from MFDS on Jan. 14, 2014)

The following products are concerned:

• A09230.02 Artificial Kidney Filter System Class 3
• A79110.02 Medication Dosage Regulator Class 3
• B03300.15 Absorbable Coronary Stent Class 4
• B03300.16 Absorbable Vascular Stent Class 4

Clarification of product name and product definition concerning 8 products was also added to remove some ambiguity.

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.