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March 1, 2024

Approximately 5 minutes

South Korea IVD Registration: Risk Classification and Expedited Third-Party Review

South Korea IVD Device Registration Pathways (MFDS)

In South Korea, the registration of In-Vitro Diagnostic (IVD) devices is governed by the Ministry of Food and Drug Safety (MFDS). The time and cost for registration depend on the device's risk classification (Class I-IV) and whether a Substantial Equivalent (S.E.) or predicate device is already registered locally.

Classification and Review Process

South Korea's classification system for IVDs aligns with GHTF guidelines. The primary determinant of the regulatory pathway is the risk class and the existence of an S.E.

ClassPredicate (S.E.) StatusReview PathwayReviewerTime (Working Days)
Class INot ApplicablePre-Market Notification (PMN)MFDS5 days (1 week)
Class IIWith S.E.Third-Party ReviewCertified Reviewer35 days
Class IIWithout S.E.Safety & Efficacy Review (SER)MFDS80 days
Class III/IVWith S.E.Pre-Market Approval (PMA)MFDS65 days
Class III/IVWithout S.E.Safety & Efficacy Review (SER)MFDS80 days

Key Regulatory Considerations

  1. Local Agent: Foreign IVD manufacturers must appoint a licensed Local Agent to submit and hold the registration certificate in Korea.
  2. Expedited Review: Class II devices that successfully demonstrate Substantial Equivalence qualify for an expedited review by one of the six designated Third-Party Reviewers. This significantly reduces the time-to-market compared to the 80-day SER route.
  3. Predicate Determination: Predicacy is determined by a formal review based on 5 to 6 key categories, ensuring the comparison is rigorous and meets MFDS standards.
  4. Local Fees: Registration fees vary by pathway, ranging from approximately US$35 for Class I PMN to US$1,500 for the Class II third-party review.

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Questions & Answers (4)

A
Guest

Our IVD is a Class III molecular diagnostic. Under the 2026 IVD Act amendments, if we cannot identify a 'Substantially Equivalent' (SE) predicate in the MFDS database, are we automatically channeled into the Safety and Efficacy Review (SER) pathway, and how does this affect our 'Technical Document Review' (TDR) timelines compared to the traditional 80-day window?

ElendiLabs

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%.

A
Guest

Our product is a cloud-based SaMD (Software as a Medical Device) that analyzes genomic sequences. Under the Digital Medical Products Act (effective 2025/2026), do we still apply for a traditional 'Manufacturing/Import License,' or are we now subject to the new 'Performance Certification' system? Also, what are the new requirements for 'Electronic Intrusion Response' in our QMS?

ElendiLabs

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.

A
Guest

As a foreign manufacturer, our KGMP (Korean Good Manufacturing Practice) audit is due in 2026. Given the new focus on digital products, if our manufacturing site is already MDSAP-certified, can we bypass the on-site inspection for our IVD software facility? Also, can our Korea License Holder (KLH) manage the required monthly supply reports?

ElendiLabs

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).

A
Guest

We are developing a CDx for a targeted oncology therapy. Does the MFDS now support a simultaneous 'Co-Review' of the drug and the IVD, or must we still wait for the New Drug Application (NDA) to reach a certain phase before filing the IVD technical file? Furthermore, will the MFDS accept bridging study data from our US/EU clinical trials for analytical validation?

ElendiLabs

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).

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