Question 1

Which facility types require KGMP certification?

Accepted Answer

Any foreign manufacturing site producing medical devices for import and sale in Korea must obtain KGMP certification from the MFDS. This applies to manufacturers, sterilization facilities, and contract manufacturers involved in the production of devices registered in Korea.

Question 2

How long does the KGMP certification process take?

Accepted Answer

From application submission to certificate issuance typically takes 6 to 12 months, depending on the device class, the completeness of the initial documentation package, and the MFDS review workload. Preparation prior to application — including gap assessment and mock inspection — adds 2 to 4 months.

Question 3

Does the MFDS always conduct an on-site inspection?

Accepted Answer

For most device classes, the MFDS conducts an on-site inspection of the foreign manufacturing facility as part of the certification process. The inspection may be conducted by MFDS inspectors traveling to your site, or by a designated local authority under a mutual recognition agreement, depending on your country.

Question 4

What happens if our facility fails the MFDS inspection?

Accepted Answer

A failed inspection triggers a corrective action and response cycle. Depending on the severity of the findings, this may require a re-inspection before certification can proceed. We manage the full response — drafting the corrective action plan, verifying implementation, and submitting the response to MFDS — to minimize the delay to your certification.

Foreign Manufacturer KGMP

A failed MFDS facility inspection freezes your entire Korean supply chain.

Documentation & Gap Assessment

Mock Inspection & Preparation

Certification Management

Service specification

Korea Foreign Manufacturer KGMP

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