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.…
2016 is here now so Happy New Year first of all ! So in Korea now we are all one year older. Yes, A baby in Korea will not gain one year on his or her birthday. Instead, people will gain one year together on January 1st of every year (New Year’s Day). This is what “Korean age” is.…
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…