South Korea Medical Device Regulatory Updates 2026: Changes and Pending Items

1. Key takeaways

The 2026 changes in South Korea concentrate on three lines. First, MFDS pre-notified a draft amendment to the Medical Devices Act Enforcement Rule on March 3, 2026 with four adjustments: change management shifting to a negative-list regime, the conditional approval fulfilment confirmation period shortened from 20 days to 10 days, an ex officio revocation procedure for sales and rental businesses, and the recall standard expanded to non-conformity with approved test specifications. Second, the second phase of the Digital Medical Products Act took effect January 24, 2026, extending scope to digital health and health support devices. Third, the Enforcement Decree was amended February 9, 2025, delegating publication of foreign object contamination investigation results to regional food and drug safety directors (current version Presidential Decree No. 36445, promulgated June 23, 2026, effective July 1, 2026).

• Status flag: the Enforcement Rule draft amendment had not been formally promulgated as of October 29, 2026 and remains pre-notified; the current Enforcement Rule is Prime Ministerial Decree No. 2127 (effective July 1, 2026), whose Article 17(2) conditional approval confirmation period remains within 20 days. Do not execute the pre-notified content as a current obligation.
• The four directions point one way: compress review before the event, raise accountability after it. Change management and conditional approval are relaxations; the recall standard and ex officio revocation are tightenings. Reading only what was loosened misses what was added.

2. Legal basis

The following instruments and timeline summarise the 2026 changes and their current status.

2026 change timeline

3. Expert insights

Insight 1: the four 2026 adjustments are one combined move.

Change management moves to a negative-list regime, so more changes are self-managed; the recall standard expands to approved test specifications, tightening the post-event yardstick; and the ex officio revocation procedure is standardised. Read together: release before the event, scrutiny after it. The capability to build is self-justification and self-documentation, not reliance on the authority’s pre-screening.

Insight 2: shortening 20 days to 10 days transfers time pressure to pre-application preparation.

Halving the conditional approval fulfilment confirmation period looks like acceleration but compresses the window to supply missing documents; the familiar submit-first approach becomes less viable. When KGMP fulfilment within a set period is the condition, use the condition list as a pre-application checklist. As of October 29, 2026 the draft is not promulgated; Article 17(2) remains within 20 days and the 10-day position is only pre-notified.

Insight 3: moving the public announcement forward in the ex officio revocation procedure gives companies an answer window.

Before revocation the company receives advance notice and the matter is announced on the authority’s website for at least 10 days. Add website announcements to routine monitoring — that window may be the only chance to save the licence.

Insight 4: the real threshold of the second phase is the applicability determination, not the documents.

Digital health and health support devices came under the Digital Medical Products Act from January 24, 2026, as described in the guide on the Digital Medical Products Act. The most common error is not the documents but leaving such products on the old route. Run a written applicability determination for any borderline product.

4. Practical recommendations

• Work the pre-notification now, but do not execute it as current obligation. The formal text may be adjusted slightly but the direction is clear; start revising internal procedures now and align wording after promulgation. In execution, the confirmation period remains within 20 days and the recall standard remains non-conformity with standard specifications until promulgation.
• Close the change management procedure gap first. The change self-assessment and management procedures must be submitted with the initial licence application; missing this step stalls the market access stage, as described in the guide on change management from item-by-item pre-approval to the negative-list regime.
• Redo the recall trigger criteria. Write non-conformity with approved test specifications into the recall judgement list and run a retrospective comparison of the last three years of production data, as described in the guide on medical device recalls.
• Check the company’s own sales and rental business status. Verify the statutory conditions item by item so no obvious defects surface in the ex officio revocation procedure.
• Set up a monthly regulatory scanning routine. Once a month, scan the National Law Information Center and MFDS pre-notifications and notices, and archive the results.
• Enter the change dates into the compliance calendar. The dates should be managed together with item renewal and KGMP milestones, as described in the guide on the Korean post-market compliance calendar.

5. Verification checklist

• □ Draft amendment status: as of October 29, 2026 it is pre-notified and not promulgated; the current Enforcement Rule is Prime Ministerial Decree No. 2127, Article 17(2) still within 20 days; uncertain items flagged.
• □ Change management and conditional approval: procedures written and ready to submit with an application; confirmation period executed at the current within-20-days position with a contingency plan for the pre-notified 10-day position.
• □ Recall standard: check whether the recall judgement list contains non-conformity with approved test specifications; both positions are written in and production data has been compared retrospectively.
• □ Sales/rental business compliance: verify the statutory conditions item by item together with announcement monitoring; no known defects and an announcement monitoring action is in place.
• □ Applicability determination: a written determination exists for borderline products; the attribution to the Medical Devices Act or the Digital Medical Products Act is clear.
• □ Monitoring and calendar: monthly scanning records checked against the unified compliance calendar; records continuous and timestamped, change dates managed on the same sheet as existing milestones.

Regulatory information verified as of October 29, 2026.

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 adverse event reporting and recall coordination with MFDS, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com