Issues and updates related to the South Korean market. Notifications from the MFDS, market trends, public consultations, standards updates
MFDS recently revised its handbook in order to align with STED guidance from International Medical Equipment Standardization Technical Documents. The revision of MFDS guidelines STED includes more checklists, example and comments to improve the level of clarity. The Summary Technical Document (STED) format for regulatory submissions is a harmonized submission format developed by the Global…
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…
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 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”.…
KFDA Notification No. 2014-178 2014.10.31 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 several changes would occur and is collecting opinions from the industry. The original publication can be found here (published on Feb. 2, 2015).…
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…
Local Representation in Korea Appointing a Korea license holder is to be taken seriously. If you don’t, you may end up in a dead end with products you cannot put on the market. Here below we get into the details of what is a license holder, its responsibilities and other topics. It came from the…
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…
In the following pictures we added an overview of the clinical trial regulation in Korea. It gives an overview of the process for clinical study in Korea. We recently had lots of discussions on how to conduct studies we thought a brief reminder would be welcome. The first table is about the process when investigator…
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)…