inspection of dealers or rental agencies by inspection agencies designated by MFDS Korea In the past, when purchasing a medical device from medical institutions, the medical device dealers or rental agencies, were required to obtain qualifying inspection from the manufacturer or importer of the said medical devices regarding the manufacturing and quality control standards of…
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…
Public consultation about IEC 60601-1 third Edition implementation in South Korea The current dates for the implementation of IEC 60601-1 3rd Ed. (electrical safety) are as follow: June 1, 2014, all Class 3 and Class 4. Class 2 June 1, 2015 Class 1 June 1, 2016 However, there is a public consultation in-progress now. The…