South Korea, MFDS - GMP inspections

Edugar

Starting to get Involved
#1
Hi,

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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