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February 26, 2024

Approximately 5 minutes

South Korea Medical Device Registration: MFDS, KGMP, and the Substantial Equivalent Pathway

South Korea Medical Device Registration: Key MFDS Requirements

Medical device regulation in South Korea is overseen by the Ministry of Food and Drug Safety (MFDS), operating under the Medical Device Act. Foreign manufacturers must appoint a Licensed Local Agent (KLH) to submit the application, and all documentation must be provided in the Korean language.

Classification and Registration Pathways

South Korea's classification system closely follows the Global Harmonization Task Force (GHTF), categorizing devices from Class I (low risk) to Class IV (high risk). The registration pathway is heavily dependent on the device's risk class and the existence of a Substantial Equivalent (S.E.) product already registered in Korea.

ClassPathwayReviewerApproximate Time
Class IPre-Market Notification (PMN)MDITAC0 days (Accepted upon submission)
Class II with S.E.Pre-Market Approval (PMA)Third Party25 days
Class III/IV with S.E.Pre-Market Approval (PMA)MFDS65 days
Class II/III/IV without S.E.Safety & Efficacy ReviewMFDS80 days

Quality System Conformity (KGMP)

Unlike many international markets where ISO 13485 is sufficient, South Korea mandates a Korean Good Manufacturing Practices (KGMP) certification for manufacturers of Class II, III, and IV devices.

  • Validity: While the device registration license does not expire, the KGMP Certificate must be renewed every three years.

Identical Product Re-registration

A unique feature of the Korean system allows a new Independent License Holder (KLH) to rapidly re-register an identical product license based on an existing registration, provided the current license holder provides approval/attestation. This process is significantly faster and more cost-effective than a full new application, allowing manufacturers to maximize distribution channels.

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Questions & Answers (4)

A
Guest

Our manufacturing facility in Israel is Class III. We have a valid MDSAP (Medical Device Single Audit Program) certificate. Will the MFDS waive the on-site KGMP (Korea Good Manufacturing Practice) audit, or must we still prepare for a physical inspection by both a Third-Party Auditor and an MFDS official?

ElendiLabs

While Korea recognizes MDSAP data to "simplify" the process, it does not automatically waive the audit. For Class III and IV devices, an Initial KGMP Audit almost always requires a Joint On-site Inspection (MFDS + a Third-Party Auditor). However, under the 2025 reforms, if your site has "Excellent Quality Control" status or a very strong MDSAP report, you may qualify for a Document-based Audit for your renewal (every 3 years). For the initial entry of a high-risk device, you should budget for a physical site visit.

A
Guest

We are ready to ship, but our Korean distributor says we need to report our UDI (Unique Device Identification) data monthly. Is this true, or is the reporting annual like in the US?

ElendiLabs

Korea is stricter. Under the Medical Device Integrated Information System, you (via your KLH) must report "Supply Information" (who you sold to and how many) by the end of the month following the transaction. This is linked to your UDI-DI. Furthermore, any "Long-Term Follow-Up" devices (implants) require the submission of Real-World Evidence (RWE) semi-annually. Failure to keep up with these digital reports can lead to an immediate suspension of your import license.

A
Guest

We have a cloud-based AI software for MRI analysis. I heard that as of January 2025, SaMD is no longer regulated under the standard Medical Device Act. Does this mean we skip the KGMP audit, and what are the new "Transparency" requirements under the 2026 AI Basic Act?

ElendiLabs

As of January 24, 2025, digital-only devices are regulated under the Digital Medical Products Act. While this streamlines the process, the AI Basic Act (effective Jan 22, 2026) classifies healthcare AI as "High-Impact." This requires you to implement a specific Risk Management Plan and "Human Oversight" protocols. You also must provide "Explanation Materials" in Korean that describe how the AI reached its conclusion. The traditional "factory" KGMP is replaced by a Digital QMS focused on software lifecycle and cybersecurity.

A
Guest

We are entering Korea and want to use multiple distributors. If our primary distributor acts as our Korea License Holder (KLH), can we still register our product as an "Identical Product" later with a second distributor to maintain price competition, or does the first KLH have "veto" power over our license?

ElendiLabs

In Korea, the KLH legally owns the product license. If your distributor is the KLH, they essentially "own" your market access. However, Korea has a unique "Identical Product Registration" pathway. If a product is 100% identical to one already registered (same manufacturer, same specs), a second KLH can register it faster. But beware: The original KLH must usually provide a "Letter of Authorization" or a full copy of the original technical file. To avoid this "hostage" situation, we strongly recommend appointing an Independent KLH (third-party) who does not engage in sales, giving you the power to add or remove distributors at will.

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