Independent Pathway for IVD Devices and Clinical Performance Studies

1. Key takeaways

The In Vitro Diagnostic Medical Devices Act (IVD Act) was enacted and promulgated as Act No. 16433 on April 30, 2019 and effective May 1, 2020; the current version is Act No. 21525 (amended by other legislation April 7, 2026, effective October 8, 2026). IVD devices are now legislated separately and no longer follow the pathway rules of the Medical Device Act. Classes remain 1 to 4, with 3 pathways: item licence for Classes 3 and 4, item certification for Class 2, and item notification for Class 1.

• The evidence structure has 2 sets: analytical performance and clinical performance, both of which must be submitted. A clinical performance study plan requires review board approval in some cases; study implementers must receive at least 8 hours of professional education per year.
• Two special channels exist alongside: laboratory developed tests (LDT) built by medical institutions require certification, and companion diagnostics may proceed in sync with drug review. Once the IVD-versus-device boundary is fixed, the templates for the Technical Document, the comparison table and the evidence structure are fixed with it, and IVD documentation must be managed as an independent, self-contained volume.

2. Legal basis

The instruments below establish the separate IVD regime, the class pathways and the boundary drawn against the Medical Device Act. Regulatory information verified as of October 29, 2026.

IVD classes and pathways. The table maps each class to its pathway and evidence focus.

3. Expert insights

Separate legislation means switching tracks in three places: pathway, terminology and evidence. The pathway rules of the Medical Device Act do not apply to IVDs, and of the 7 statutory elements of the Technical Document, testing specifications and instructions for use do not apply in the IVD substantial equivalence comparison. Applying the device project Technical Document template directly to an IVD does two pieces of wasted work and misses the two dedicated evidence sets of analytical performance and clinical performance. The IVD project needs its own Technical Document template, built separately. The boundary determination is in Article 03: Medical device definition and scope determination.

Analytical performance and clinical performance are two evidence sets; submitting only one guarantees a deficiency. Analytical performance answers whether the assay measures accurately; clinical performance answers whether accurate measurement is useful for clinical judgment. What Chinese manufacturers habitually submit is analytical performance data, with clinical performance left to the deficiency stage. In IVD projects GRZAN schedules the preparation of both evidence sets in parallel and up front, because filling in clinical performance usually involves new clinical samples and institutions whose timelines cannot be compressed. Searching for samples and institutions at the deficiency stage means the waiting time is set by the other party’s schedule.

The 8-hour professional education is a compliance item that gets traced back. Study implementers must receive at least 8 hours of professional education per year. This requirement does not appear in the product dossier, but it shows up in the qualification records of the study implementers. Missing education records cast doubt on the usability of already completed clinical performance study data, and repeating a study costs far more than maintaining education records (practical estimate: education records are maintained by the study institution itself; request and retain proof before filing). Failing to verify education records before commissioning a study hands the usability of the data to the other party. Missing records can be remedied by completing the education afterwards, but the usability of data from completed studies does not automatically recover through make-up training.

LDT and companion diagnostics are two special channels pointing in opposite directions. LDT systems built by medical institutions require certification – a constraint on the self-building conduct of medical institutions; companion diagnostics may proceed in sync with drug review – an acceleration for companion diagnostic products. The former adds one certification duty; the latter saves a stretch of waiting time. Companies planning the order of product applications should fold both channels into the pathway judgment rather than discovering their applicability at filing time, see Article 20: Pre-market pathway selection decision tree.

4. Practical recommendations

• Determine IVD status first, then the class. Confirm that the product falls under the In Vitro Diagnostic Medical Devices Act, then determine the pathway by Classes 1 to 4; the status conclusion directly determines the choice of Technical Document template. The dividing lines of the three pathways are in Article 11: Three market entry pathways – the dividing lines among item licence, item certification and item notification.
• Prepare the two evidence sets in parallel. Start analytical performance and clinical performance at the same time, lock in the samples and institutions for clinical performance as early as possible, so that both evidence sets complete at the same node.
• Confirm review board approval needs early. In some cases a clinical performance study plan requires review board approval; confirm before filing whether this product falls into such a case. Falling into it without approval makes the study data unusable (practical estimate: subject to the case-by-case reply of the authority).
• Obtain the study implementer education records. Before commissioning a study, verify completion of the annual 8-hour professional education and retain proof; the retained proof must cover the period in which the study was conducted.
• Align companion diagnostic scheduling with drug review. Where synchronized review with the drug applies, back-plan the IVD filing rhythm from the drug review milestones; synchronized does not mean merged review – the IVD documentation must still stand as an independent volume.

5. Verification checklist

• □ Applicable law: check the In Vitro Diagnostic Medical Devices Act (Act No. 16433, current Act No. 21525, effective October 8, 2026) against Article 2 of the Medical Device Act; clearly governed by the IVD Act, no unresolved overlaps.
• □ Class determination: determine under the IVD class classification criteria; Classes 1 to 4 conclusion clear and traceable.
• □ Pathway mapping: check the three pathways against the class; licence for Classes 3/4, certification for Class 2, notification for Class 1.
• □ Analytical performance evidence: check the completeness of analytical performance study data; precision, accuracy and other items complete.
• □ Clinical performance evidence: check clinical performance study data and plan; an approved study plan and result data present.
• □ Review board approval: check whether the case requiring approval is met; where met, approval obtained.
• □ Study implementer education: verify the annual education duration records; at least 8 hours per year, with retained proof.
• □ Special channel applicability: determine whether LDT or companion diagnostics applies; LDT certified, or companion diagnostics aligned with drug review.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, Korean licence holder and local testing support for the Republic of Korea. Our team prepares MFDS-compliant technical dossiers, coordinates KGMP documentation, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com