MFDS guidelines ECG HF stimulation

Korean MFDS guidelines ECG HF stimulation was recently published (June 12, 2015) in order to help completion of medical device license and technical documentation. The products covered are high frequency stimulation and electrocardiograph. The guidelines describe a variety of high-frequency stimulation of different properties/techniques as well as electrocardiographs. The structure of the guideline is such…

Implants traceability requirements

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…

Korean Health Industry market

Korean Health Industry market over the past decade has shown a growth of more than twice.Exports also increased more than four times as per 2013 record of $ 5.76 billion compared to $ 1.5 billion in 2004. Korea Health Industry Development Institute is publishing a report “health industry over the past 10 years and future direction”.…

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 device regulations update on a regular basis. It recently published a notice to inform that a reclassification and re-categorization of products would occur. Reclassification of 244 products previously known as in vitro radio-pharmaceuticals to medical devices  guideline…

Medical Device Distribution Quality Management in Korea

Background Recently Korean Ministry of Food and Drug Safety (MFDS previously called KFDA) published its quality management standard for distributors operating in South Korea. Is your distributor ready ? After strengthening its regulation for license holders and require them to appoint a dedicated Quality Manager (effective since July 2014), MFDS is now regulating the distribution…

korean medical devices regulation update 2014-142

Notification of regulation amendment regarding approval, notification and evaluation of medical devices in Korea. A) Implantable Medical Device B) Restricted substances C) Intended Use D) Clinical Evaluation E) Medical apps Korean medical devices regulation update 2014-142 A) Implantable Medical Device The definition of Implantable medical device and its application (Article 2 and Article 5) 1)…

Korean KGMP revision

Ministry of Food and Drug Safety Notice No. 2014-155 was published on MFDS website. The Korean Good Manufacturing Practice (KGMP) being revised and this is a public consultation. South Korea medical device registration will be affected by this publication. The purpose here is clearly to improve the way KGMP is managed. Below is a summary…