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KGMP
Medical Device KGMP Compliance Recognition
Service Progress Procedure
Medical device KGMP Conformity
Recognition Application Target
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A person who wishes to obtain a medical device manufacturing/import permit or manufacturing/import certification or to file a manufacturing/import report
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A KGMP review is required prior to approval, and can be conducted simultaneously with the technical documentation review.
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A person who wishes to manufacture or import medical devices for clinical trials
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Medical device manufacturers or importers who wish to undergo conformity recognition, etc.
Medical Device KGMP Inspection Flow Chart
Application for Medical Device KGMP
Conformity Certification
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Application for Conformity Recognition: Application + List of Required Documents + Quality Management System Interrelationship + Manufacturing Site Summary
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Personal information use consent form, copy of business registration certificate
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Copy of product license or technical documentation
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Overview of the factory
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Total number of employees engaged in manufacturing and quality-related work in manufacturing
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Overview of the manufacturing facility
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Key Supplier Information
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Quality Manual (including quality policy)
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Product standard documents, etc.
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In order to be recognized as KGMP compliant for medical devices, a production performance of at least one lot must be available for review.
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