Medical Device Recalls in South Korea: Triggers, Plans and Pending Standard Expansion

1. Key takeaways

The trigger for a medical device recall in South Korea is written in Article 31(2) of the Medical Devices Act: upon discovering a situation hazardous to health, the business operator must recall the product on its own initiative and submit a recall plan to the Minister of Food and Drug Safety; Article 31(3) further provides that the Minister may order publication of the recall plan. The system is a two-tier structure with voluntary recall by the operator as the principle and the competent authority’s power to order publication as the backstop.

• One key 2026 change must be built into the quality management system in advance: the draft amendment to the Medical Devices Act Enforcement Rule pre-notified on March 3, 2026 proposes expanding the recall standard from non-conformity with standard specifications to non-conformity with the approved test specifications. The wording change extends the recall trigger from benchmarking against third-party standards to benchmarking against the company’s own approved documents — any product inconsistent with the specifications in the original application dossier may enter recall evaluation.
• This change and the negative-list change management regime in the same draft amendment are two sides of one coin: the space for company-managed changes widens, while the burden of self-verification that products after a change still conform to the approved specifications grows at the same time.
• One point must be made clearly: a search of the Ministry of Government Legislation’s historical legislation database confirms that this draft amendment had not been formally promulgated as of October 29, 2026. The current Enforcement Rule is Prime Ministerial Decree No. 2127 (promulgated and effective July 1, 2026), in which the conditional approval fulfilment confirmation period under Article 17(2) remains within 20 days, and the recall standard expansion is not yet in force. The above content is forward-looking and cannot be executed as a current obligation.

2. Legal basis

The following instruments underpin the recall obligations and the pending change described in this guide.

Note: the draft amendment is at the pre-notification stage; a search of the Ministry of Government Legislation’s historical legislation database confirms it had not been formally promulgated as of October 29, 2026. The current Enforcement Rule is Prime Ministerial Decree No. 2127 (promulgated and effective July 1, 2026), and its Article 17(2) still sets the conditional approval fulfilment confirmation period at within 20 days. The expansion described above is based on the March 3, 2026 pre-notification text (minor adjustments are possible); the promulgated text and effective date are subject to subsequent publication by the competent authority.

3. Expert insights

Insight 1: standard specifications and approved test specifications are not the same thing.

South Korea has standard specifications for certain item categories, and conformity allows simplified application documents; the approved test specifications, by contrast, are the test specifications the company itself submitted and had approved in its licence application. The former is an external benchmark, the latter is the company’s own commitment. By bringing the latter into the recall standard, the draft amendment means that when a batch’s measured performance does not match the specifications in the approved documents, a recall evaluation may be triggered even if the batch conforms to the external standard specifications. GRZAN judges that this hits hardest the companies that share one licence across many models and multiple production sites.

Insight 2: the recall trigger sits at the production end, not when a complaint arrives.

What widens the gap in remediation cost is the point of discovery. The first anomalies usually appear in release-testing trends, process capability indices, or first data after a supplier change, where handling is still internal correction; once concentrated feedback appears in the market it becomes a statutory recall and a recall plan must be submitted. Writing periodic review of testing data into quality objectives beats polishing recall techniques after the fact.

Insight 3: recalls must stay in step with IMDIS flow data.

A recall is not an isolated action. Under Article 31-2 of the Medical Devices Act and Article 54-2 of the Enforcement Rule, flow data is reported by category — shipment, return, disposal, lease and recall — to the Integrated Medical Device Information System (IMDIS), as described in the guide on distribution record reporting and supply details reporting. GRZAN requires in projects that the recall ledger and the IMDIS reporting use the same batch numbering and quantity units, so the two datasets never diverge.

Insight 4: the foreign manufacturer’s role in a recall is that of an executor, not the reporting entity.

Recall reports and recall plans to MFDS are submitted by the Korean licence holder; the Chinese manufacturer carries out cause analysis, corrective action and alternative supply. The respective duties must be written clearly into the agreement, in particular who bears recall costs and who owns the recovered batches, as described in the guide on the Korean licence holder (KLH) system.

4. Practical recommendations

• Turn approved specifications into a machine-checkable list. Organise the test specifications, test methods and acceptance limits in the licence into a structured list bound to the release report template, so every batch is compared automatically.
• Complete a gap self-check before the draft is formally promulgated. Using the non-conformity with approved test specifications standard, run a retrospective comparison of the last three years of production data per model to surface systemic shifts early.
• Pre-build a recall plan template. The template should contain at least five items: recall classification judgement, notification list, recovery and return/replacement process, time milestones, and public communication text; when an event occurs, only the facts need to be filled in.
• Combine recall drills with adverse event drills. The trigger chains of the two event types overlap heavily, so a combined drill verifies both the division of duties and the information chain in one pass.
• Review change management records at the same time. The draft amendment also introduces the negative-list change management regime; companies should confirm that change self-assessment and management procedures can be traced to specific batches, as described in the guide on change management from item-by-item pre-approval to the negative-list regime.

5. Verification checklist

• □ Trigger condition identification: list the situations that require a recall against Article 31(2); the list covers situations hazardous to health and already includes the non-conformity with approved test specifications standard.
• □ Recall standard position: check the current Enforcement Rule (Prime Ministerial Decree No. 2127) against the March 3, 2026 pre-notification text; the current standard is non-conformity with standard specifications, the draft is tracked in parallel until promulgation, and procedure documents are updated immediately upon promulgation.
• □ Recall plan elements: check the template for completeness; it contains all five elements — classification, recipients, recovery method, deadlines and communication text.
• □ Submitting entity: verify the authorisation and process documents under which the Korean licence holder submits; the submission route is unique and the Chinese manufacturer does not submit to MFDS directly.
• □ Batch traceability: trace production records, flow records and IMDIS reports backwards from the batch number; the three datasets agree and the flow terminal can be located.
• □ Standard specification comparison: verify the applicability of the Medical Devices Act standard specifications; applicability is clearly determined, and non-applicability is separately justified, as described in the relevant guide of this series.
• □ Record keeping: sample the written records and communications retained across the full recall process; records are complete enough to reconstruct the timeline in a later inspection.

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