South Korea regulation changes in 2018

South Korea regulation changes in 2018 The following regulatory changes are expected in 2018 in the South Korea regulation as published by the MFDS (Ministry of Food and Drug Safety): Main regulatory changes in South Korea regulation Adopt customized licensing system for advanced medical devices – ‘Special Act on Promotion of Advanced Medical Device Development…

Korea becomes the 10th member of IMDRF

Korea becomes the 10th member of IMDRF After the U.S., EU, Canada, Australia, Japan, China, Brazil, Russia, and Singapore, Korea has become an official member of the International Medical Device Regulatory Forum (IMDRF). This was announced officially on the Korea MFDS (Ministry of Food and Drug Safety) website as of December 11, 2017 and it…

KGMP guideline Rev.4 in English

KGMP guideline revision The Korean GMP (KGMP) guideline has been updated earlier this year (2016) and even if it was only provided in Korean we prepared a translated version in English. More details were provided in the guideline and the case of in vitro diagnostic equipment was considered since those were reclassified as medical devices.…

Guideline for pulse oximeters

This guideline for pulse oximeters was prepared to help the writing of the technical documentation and subsequent approval. pulse oximeters are commonly used to measure the concentration of oxygen in the blood. Main content of this guideline includes: medical equipment approval authorization process approval and technical requirement items, and examples of technical requirements. MFDS Evaluation…

Guideline for polypropylene suture

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…

Performance test in Korea

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 guidelines STED

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…