Korean Ministry of Food and Drug Safety MFDS has announced that in order to expand European market of medical devices they are holding a working meeting at the MFDS office with Polish and Czech pharmaceutical and medical equipment registration office. This working meeting was arranged to follow up with high level officer meeting in 2013…
This guideline for polypropylene suture was prepared to help the writing of the technical documentation and subsequent approval. Polypropylene suture is a non-absorbable type of suture used for approximating and ligating soft tissue. Main content of this guideline includes: medical equipment approval authorization process approval and technical requirement items, and examples of technical requirements. MFDS…
In some cases performance requirements are not defined in the Korean regulation. That’s sometimes a good thing, and sometimes not. Performance test in Korea, means confirmation of the intended use and functional test at the same time. Let’s say for instance in the case of active devices, compliance with a particular standard like IEC 60601-2-X…
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…
China International Medicinal Equipment Fair (CMEF), founded in 1979, is held twice a year – spring and autumn. After 30 years of continuous innovation and self-improvement, CMEF has become the largest exhibition of medical equipment, related products and services in the Asia-Pacific region. The exhibition widely covers ten thousands of products such as medical imaging,…
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…