韓國 IVD 註冊：風險分類與加速第三方審查

Yes. If no predicate is recognized, you must undergo the SER pathway. While a standard TDR (for SE devices) aims for roughly 65–80 business days, the SER requires a clinical data review, which typically extends the timeline to 120–150+ business days. • Key 2026 Change: The MFDS now allows "Custom Classification" for novel technologies. If your device uses innovative AI, you might qualify for a priority review under the Digital Medical Products Act, potentially shortening the review cycle by 30%.

Under the new Act, digital-only IVDs (SaMD) follow a specialized Performance Certification track. • Cybersecurity: You must now include a "Digital QMS" section. It should include a lifecycle plan for software patches and a vulnerability management protocol aligned with IMDRF cybersecurity guidelines. • Labeling: Your digital interface must display the specific "Digital Medical Device Software" label and your software versioning must be tracked via the IMDIS (Integrated Medical Device Information System) portal.

While Korea participates in MDSAP, the MFDS still reserves the right to conduct on-site audits for Class III/IV devices, especially for the "first-time" registration of a new technology. However, for SaMD, the audit is often a "Desktop Audit" (Documentation Review) focusing on software development lifecycles (IEC 62304). • Supply Reports: Your KLH is legally responsible for the Monthly Supply Report via the IMDIS portal. They need provide distribution data (quantities, lot numbers, and destination hospitals).

As of 2026, Korea has moved closer to the "Co-Review" model seen in Japan and the US, but it is not yet fully integrated. • Protocol: You are encouraged to submit the IVD technical file in parallel with the drug's Phase III data. • Data Acceptance: The MFDS will accept foreign clinical data, but you must provide "Bridging Evidence" specifically for the Korean population (e.g., demonstrating that ethnic factors do not impact the diagnostic's Cut-Off values or Limit of Detection).