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South Korea, MFDS - GMP inspections


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I have had some guidance translated for GMP Inspection on the Overseas Manufacturers of Import Medical Devices in South Korea (please find it attached). The document is not very clear, so I was hoping to seek some clarification on the following questions:
  1. Is there any updated guidance about this subject?
  2. Is there any clear definition of manufacturer and subcontractor?

Any help/advice would be gratefully received.



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From a UL newsletter:

South Korea MFDS: MFDS Notice No. 2019-25 finalized the revision of K-GMP requirements to align with ISO 13485:2016, effective 1 July 1, 2019.

Unfortunately, the link is not working anymore, and I was not able to locate the text on the homepage .


your attachment is not Latest version. however, In case of the Korea GMP(KGMP) is very similar the ISO 13485:2016. As I knew, korea FDA(MFDS) want join the MDSAP. to do this, MFDS has been strengthen the medical device act. In this issue point is different the Manufacturers and Importers. in case of the Manufacturers, do not have problem because, KGMP is similar the ISO 13485:2016. however, importers is some have problem. anyway, MFDS does not provide the medical device act and guideline of english version. if you need a some help. please let me know.
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