Clinical Data Requirements: Clinical Trial Plan Approval and Data Composition

1. Key takeaways

To conduct a medical device clinical trial in Korea, approval of the clinical trial plan by the Ministry of Food and Drug Safety (MFDS) must be obtained in advance under Article 10 of the Medical Device Act. The plan approval and the item licence are two independent administrative acts: only an approved trial plan can produce clinical data usable for an application, and reversing the order renders an entire round of data unusable.

• Whether a device falls into the clinical-trial-required category directly determines the statutory review period for Class 3 and Class 4: 55 working days without a clinical trial, 70 working days with a clinical trial, a gap of 15 working days. This is the largest single variable in the Korea project timeline.
• Low-risk digital medical devices among digital health products may be exempt from the prior approval of the clinical trial plan. Exemption and waiver are two different things: what is waived is the prior approval procedure, not the clinical evidence itself.

2. Legal basis

The instruments below govern clinical trial plan approval, clinical documentation requirements, statutory review periods and the digital health exemption. Regulatory information verified as of October 29, 2026.

Three sources of clinical data and how to handle each. The usability conditions for overseas data and literature summarized below reflect GRZAN project experience (practical estimate) and must be confirmed with the accepting authority in advance.

3. Expert insights

Plan approval is an independent gate; running it backwards wastes an entire round. Article 10 of the Medical Device Act requires prior approval. Starting the trial first and completing the paperwork afterwards makes the data already produced unusable as supporting evidence at application. GRZAN manages plan approval as an independent milestone in scheduling, with its preparation period run in parallel – not in series – with the preparation of the item application dossier. Both the preparation period for plan approval and the trial execution period must be counted into the total project timeline; neither can compress the other.

The gap between 55 and 70 working days is the largest single variable in timeline management. The statutory review periods for Class 3 and Class 4 devices are 55 working days without a clinical trial and 70 working days with one, a difference of 15 working days. Beyond these 15 working days, the trial execution period and the preparation period for plan approval must be added on top. GRZAN treats the question of whether a clinical trial is required as the first question mark in pricing and scheduling, because the answer sets the baseline of the entire project; once the answer falls on either side, the gap is magnified segment by segment through the downstream steps.

The usability of overseas clinical data must be confirmed before filing, not explained after filing. The conditions under which overseas clinical data are usable in Korea depend on population comparability, endpoints and trial methodology. The GRZAN approach is to prepare a written bridging statement before filing and to confirm any doubt in advance (practical estimate: the specific usability conditions must be confirmed with the accepting authority beforehand). The three elements of the bridging statement – population comparability, endpoints, and trial methodology – cannot be missing any one of them without triggering a request to supplement. Submitting the bridging statement only at the deficiency stage amounts to voluntarily giving up a round of time; submitting it early moves the uncertain element forward into the dossier preparation stage.

The digital health exemption is layered and holds only for low risk. The Digital Medical Products Act exempts low-risk digital medical devices from prior approval of the clinical trial plan; it is not an exemption across the board. Before software and AI products have their risk class determined, the applicability of the Digital Medical Products Act must be assessed first, see Article 28: Documentation requirements for software medical devices and AI devices and Article 09: Digital Medical Products Act. Digital medical products beyond the low-risk tier remain subject to the approval requirement of Article 10 of the Medical Device Act.

4. Practical recommendations

• Make the clinical-trial question the first question of the project. Complete the determination before dossier preparation begins; the conclusion directly determines whether scheduling follows 55 working days or 70 working days. Where a trial is required, both the trial plan preparation period and the trial execution period are counted in.
• Run the trial plan filing in parallel with product dossier preparation. The two preparation periods can overlap; handling them in series doubles the timeline. The trial protocol version and the final report version must correspond, and any mid-course protocol change must leave a change record.
• Prepare the bridging statement for overseas data first. Produce a written document stating population, endpoint and methodology comparability, and confirm the usability conditions before filing (practical estimate).
• Leave a complete search trail on the literature route. Record the systematic search strategy, the inclusion and exclusion criteria and the search dates in full for review traceability. The search document must map item by item to the clinical evaluation conclusions; a bare bibliography is not enough.
• Set an internal deadline for deficiency responses. Respond within an internal time limit after receiving a deficiency notice; the effect of a deficiency on the review period is as stated in the deficiency notice of the accepting authority, and the process is described in Article 30: Electronic submission and application process – key operational points.

5. Verification checklist

• □ Clinical trial plan approval: check the approval document against the trial protocol version; Article 10 approval obtained before the trial is conducted.
• □ Clinical-trial determination: determine by item and class whether a clinical trial is required; conclusion clear and consistent with the intended application pathway.
• □ Review period basis: check Annex 1 of the Enforcement Rule; the 55 or 70 working day basis is used, not mixed with calendar days.
• □ Bridging of overseas data: check the completeness of the bridging statement; population, endpoints and methodology all covered.
• □ Literature search trail: check the search strategy and date records; strategy, inclusion criteria and search dates all present.
• □ Trial sites and records: check trial execution records and source documents; records traceable to subjects and time points.
• □ Digital medical product exemption: determine whether the product is a low-risk digital medical device; where an exemption applies, the basis is stated at filing.
• □ Clinical data consistent with the Technical Document: cross-check intended use, specifications and contraindications; wording consistent with the Technical Document.

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