J
johnq98
It is said that the Korean GMP requirements are similar to ISO 13485 but my search for a comparison between Korea's standard and ISO 13485 is no where to be found. Can someone direct me to any source for that information.
Hi,
KGMP was changed from 13485:2003 to 13485:2016 compatibility, but there is no information in English available yet. All I have found is
의료기기 제조 및 품질관리기준 일부개정고시(안) 행정예고(식약처 공고 제2018-409호) 상세보기|입법/행정예고 | 식품의약품안전처
Does anyone know, until we can expect to get the Korea regulation requirements in English?
Can you post the link to the 2021 version, please? I looked for it on the homepage, but I am a clueless one regarding Korean language, and on the English version of the homepage, nothing is written about a new version...Nope, latest revision of KGMP is dated August, 2021 and the latest English version of KGMP is 2019, which is now totally invalid and dated version.
FYI, KGMP follows almost word to word from ISO 13485:2016 version so just following ISO can do you benefit.
Can you post the link to the 2021 version, please? I looked for it on the homepage, but I am a clueless one regarding Korean language, and on the English version of the homepage, nothing is written about a new version...