Innovative Medical Device Fast Track in South Korea

1. Key takeaways

The Act on Fostering the Medical Device Industry and Supporting Innovative Medical Devices (the Medical Device Industry Act) was enacted and promulgated as Act No. 16405 on 30 April 2019, effective 1 May 2020; the current version is Act No. 21263 (amended by other statutes 30 December 2025, effective 1 July 2026).

The Act establishes a fast track for innovative medical devices, each tool anchored to a provision: Article 21 provides for innovative medical device designation, with the competent authority required to decide within 30 days of the designation application; Article 22 paragraph 2 provides for staged review in 4 stages; Article 22 paragraph 5 for priority review; Article 22 paragraph 6 for special review standards, giving products lacking general standards an evaluation basis. The advance certification system and innovative device group designation (each valid 3 years) allow business licence exemptions, with post-market study within 5 years under Article 23.

The mechanism addresses technology iterating faster than review cycles: on the regular pathway a new-technology product submits against complete evidence requirements and can be overtaken before its evidence is complete. The fast track moves the review intervention earlier and splits evidence requirements into stages.

GRZAN’s judgment: the fast track suits products genuinely at the technology frontier, not modified products the regular pathway can already handle; it pays off only when the main pathway’s schedule cost exceeds the designation investment.

2. Legal basis

The fast track rests on the following instruments.

Innovative medical device support tools (under the Medical Device Industry Act)

3. Expert insights

The 3-year validity of the advance certification system is a window, not a guarantee. The advance certification system and the innovative device group designation form two parallel 3-year windows. The window gives the company an identity to advance on while evidence is incomplete; after it closes, the product still returns to the regular pathway. GRZAN advises scheduling evidence accumulation backwards from the 3-year mark and using the window fully.

Staged review proceeds in 4 stages and changes the submission rhythm, not the review standard. Article 22 paragraph 2 sets staged review at 4 stages, allowing segmented submission and review, which most benefits products with long development cycles and evidence arriving in batches; it lowers waiting cost, not the evidence threshold. Article 22 paragraph 6 separately provides the special review standards: where no general review standard can yet be cited, the product is evaluated against standards set case by case. GRZAN manages the Industry Act staged review separately from the staged review under MFDS Public Notice No. 2022-52: the former is a support mechanism, the latter a regular-pathway procedure; their trigger conditions differ and must not be mixed.

The post-market study of up to 5 years under Article 23 is the price of the fast track. An innovative medical device may, because its evidence is not yet sufficient, have to undergo a post-market study of within 5 years under Article 23; the ceiling is set by statute and the specific period is stated case by case when implementation is determined. This shifts part of the evidence burden from before market entry to after it. GRZAN books the study into the total project cost at assessment: data collection, analysis, and reporting are ongoing expenses a company must be able to bear before applying for designation.

Designation is a one-time decision within 30 days; do not conflate designation with the later fast-track reviews. Article 21 grants a procedural judgment on whether to confer innovative status, with a statutory decision period of within 30 days of application. The short period means the materials must carry a complete innovation argument at submission, not patched in while under review. GRZAN schedules designation separately from later fast-track steps: secure the designation conclusion first, then combine staged review, priority review, and special review standards (practical estimate: set case by case by evidence maturity).

Digital medical products have a separate exemption channel for clinical trial requirements. The Digital Medical Products Act exempts low-risk digital medical devices from prior approval of clinical trial plans. For a product both innovative and digital-health related, clarify the two channels’ relationship first: designation settles the review rhythm; the Digital Medical Products Act settles that category’s documentation and procedural requirements. Fix their order at the applicability determination stage to avoid conflicting baselines from parallel submissions.

4. Practical recommendations

• Assess first whether the fast track is worth taking. It pays off only when the regular pathway’s schedule cost exceeds the designation investment (practical estimate).
• Schedule evidence accumulation backwards from the 3-year window. Both windows last 3 years; complete key evidence within them.
• Distinguish the two staged reviews. The Industry Act review and the one under MFDS Public Notice No. 2022-52 differ in trigger conditions; manage them separately.
• Book post-market study costs into the total budget. Under Article 23 the study period is within 5 years, with data collection and reporting as ongoing expenses.
• Confirm clinical trial exemption applicability for digital products in the same pass. Low-risk digital medical devices can be exempt from prior approval of clinical trial plans; confirm this at the applicability determination stage.
• Schedule designation materials backwards from the 30-day decision period of Article 21. Materials must be complete at submission; within the statutory 30-day period there is usually no room for batch supplementation.

5. Verification checklist

• □ Statutory applicability — check the effective dates of Act No. 16405 (current No. 21263); standard: applicable from 1 May 2020.
• □ Innovative character — checked against the designation conditions; standard: a supporting innovation argument exists.
• □ Advance certification window — check the designation documents; standard: valid for 3 years with the window plan scheduled.
• □ Innovative device group designation — check the designation documents; standard: valid for 3 years with the device group scope clearly defined.
• □ Staged and priority review — check the arrangements; standard: applicable formats and trigger conditions confirmed.
• □ Post-market study — check the designation conditions and Article 23; standard: period within 5 years, obligations and owners assigned.
• □ Designation decision period — check Article 21; standard: scheduling based on a decision within 30 days of application.
• □ Digital medical applicability — checked against the Digital Medical Products Act; standard: clinical trial plan prior approval exemption status confirmed.

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 manages MFDS approvals, certifications and notifications, prepares equivalence dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com