I would like to inform you of the KOREA Medical Device GMP audit days change.

From March 01, 2023, the GMP audit days will be changed.
It depends on the number of persons related to quality.

To sum up, it is longer than before as follows.

For 1~25 persons, from 2 days to 3 days

For 26~65, 3 days to 5 days

For 66~125, 4 days to 6 days

For 126~175, 5 days to 7 days

For 176~275, 6 days to 9 days

Over 276, 7 days to 10 days.

※ If there is a special process (a process that uses human tissue or animal-derived materials to remove pathogenic substances such as bacteria and viruses, other than general medical device sterilization processes such as EO gas sterilization, high-temperature and high-pressure sterilization, and radiation sterilization), the number of MDs may be added.

If you have any questions, please mail to chk3424@naver.com