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MFDS Issues Practical Guidance on Using MDSAP Materials in Korea Device Inspection and GMP Pathways

MFDS has issued guidance on responding to MDSAP-related review scenarios for medical devices in Korea. For manufacturers and Korean import-license holders that already operate under MDSAP, the guidance is relevant to how audit reports and CAPA records may be used to support or simplify Korea-facing inspection and GMP processes.

By MedTech Current

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The guidance focuses on how MDSAP materials can be used in Korea-facing compliance work

MFDS has issued guidance titled MDSAP 심사 대응 가이드라인, aimed at medical-device companies dealing with Korea-related inspection and GMP requirements.

For companies that already hold MDSAP certification, the practical question is not whether the audit exists, but how the resulting audit report, findings, and CAPA evidence can be used in a Korean compliance context.

The main value is quality-system reuse

The guidance addresses how manufacturers and import-license holders can use MDSAP audit reports and CAPA materials to support Korea-facing inspection handling.

That is especially relevant for export-oriented manufacturers trying to reuse existing quality-system evidence instead of rebuilding a Korea-specific inspection package from scratch.

It should be read as an operational-use guide, not an automatic exemption

The useful compliance question is how far an existing MDSAP package can carry into Korean workflows and what additional bridging materials still need to be prepared.

A company with an MDSAP certificate should not assume that Korean inspection requirements disappear automatically.

The more practical reading is that MFDS is clarifying the framework for when and how MDSAP evidence can be presented, and what supporting documentation should accompany it.

What companies can check

  • Confirm which facilities and product lines already have valid MDSAP certification.
  • Organize the underlying audit report, nonconformity closure records, and CAPA evidence in a submission-ready format.
  • Identify which Korea import or GMP scenarios may allow simplified or alternative handling based on MDSAP evidence.
  • Map the relationship between current MDSAP evidence and Korea KGMP expectations.
  • Consider piloting the approach with priority product lines intended for Korean market entry.

For companies planning Korean expansion, the guidance is best viewed as a quality-system reuse opportunity. The real benefit is not the existence of the certificate itself, but whether it can shorten or simplify market-access execution in Korea.

Sources

  1. Primary official sourceMDSAP 심사 대응 가이드라인Ministry of Food and Drug Safety