On-site due diligence at medical device overseas manufacturing sites
The Ministry of Food and Drug Safety announced that 16 overseas manufacturing plants producing medical devices imported into Korea that are deemed to be in need of fact-checking on harm prevention and safety and efficacy information will be selected as targets for on-site inspections in 2024 and will conduct on-site inspections starting in March.
To this end, MFDS has revised its guidelines detailing administrative procedures, inspection contents and methods, and follow-up measures to internalize overseas due diligence work and improve industry understanding, and has strengthened specialized training for medical device inspectors to thoroughly prepare for local inspections.
The MFDS expects that local due diligence will help increase the reliability of imported medical device quality, and has stated that it will continue to do its best to strengthen safety management so that people can use medical devices that are safe from the manufacturing stage overseas with peace of mind.
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