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Daily Archives: March 2, 2013

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South Korea KGMP inspection requirements

South KoreaBy NicolasMarch 2, 2013Leave a comment

Starting here is a serie of posts related to Korean Regulation, the first one being about South Korea KGMP inspection requirements which is equivalent of the US Good Manufacturing Practice. Quality system regulations (KGMP)   All Medical Devices are required to be manufactured under GMP. Premarket GMP audit is mandatory for all class II, III…

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