Registro de Dispositivos Médicos na Coreia do Sul: MFDS, KGMP e a Via de Equivalência Substancial

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.

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.

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.

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.