Distribution Record Reporting and Supply Details Reporting in South Korea

1. Key takeaways

South Korea’s distribution record reporting (유통기록 보고) duty is constituted jointly by Article 31-2 of the Medical Devices Act (supply details reporting) and Article 54-2 of the Enforcement Rule, rolled out by class across 4 year-milestones from July 1, 2020: class 4 from July 1, 2020, class 3 from July 1, 2021, class 2 from July 1, 2022, and class 1 from July 1, 2023 — full class coverage has applied since class 1.

• The reporting content revolves around five data groups: manufacturing number and manufacturing date, expiry date, distributed quantity, and distribution date; when distributing to medical institutions, the distribution amount and unit price must also be reported. All data is maintained separately under five categories: shipment, return, disposal, lease and recall.
• The practical value of the system goes far beyond submitting data: it is the base ledger with which the competent authority verifies product flow, corroborates adverse event handling and confirms recall effectiveness, and it interlocks with the qualification-side timeline, as described in the guides on item renewal and medical device recalls.
• On reporting frequency: in the legal system described here, the reporting platform, category definitions and data items are all clearly positioned; as for specific frequencies such as semi-annual or monthly submission — a practical estimate — this guide marks every frequency-related point as subject to the current notices and the operating requirements of the Integrated Medical Device Information System (IMDIS).

2. Legal basis

The following instruments define the reporting duty, its procedures and the phased start dates.

Phased application start dates

3. Expert insights

Insight 1: the difficulty of this duty lies in data granularity, not in the act of reporting.

The law requires distribution actions to be maintained under five categories — shipment, return, disposal, lease and recall — with granularity at the manufacturing number level, not the product name level. Most companies’ ERP systems manage batches by SKU, and once the DI/PI structure of UDI and the IMDIS fields come in, the workload of data mapping surfaces. GRZAN recommends producing a field mapping table before any system modification.

Insight 2: the price fields for supplies to medical institutions are the interface with the health insurance system.

When flowing to medical institutions, the distribution amount and unit price must be reported; the legal implication is that the company must master end-market price data. A common weakness of companies selling through distribution tiers is the inability to obtain end prices, leaving them to report shipment prices, which falls short of the statutory scope. GRZAN recommends stating a data-return duty in distribution agreements rather than chasing distributors after the fact.

Insight 3: data consistency becomes a verification tool for later regulatory actions.

When an item triggers an adverse event, a recall or a re-evaluation, the competent authority already holds a complete flow ledger to cross-check against the company’s reports. GRZAN’s judgement: errors in distribution data rarely bring immediate penalties, but they surface at the critical moment and sharply raise the cost of explaining.

Insight 4: the consistency check at the import declaration stage must be done first.

Before imported items are placed on the market, the medical device standard code information on containers and packaging must be consistent with the IMDIS data, as described in the guide on import declaration and customs clearance. If the UDI information of a device and the manufacturing number rules in the distribution report are inconsistent, a code segment conflict appears on the very first shipment.

4. Practical recommendations

• Trace applicable start dates backwards by class, leaving no blind spots. Mark each item’s class and corresponding start date one by one, especially old certificates approved years ago with models added recently.
• Create unified accounts for the five categories. Shipment, return, disposal, lease and recall should each have an independent account code in the ERP, not be distinguished by remark fields.
• Lock data return into distribution agreements. State the delivery deadlines, format and liability for breaches for end-market flow, amount and unit price data.
• Run a semi-annual IMDIS data health check. Sample and compare system data against the company ledger, focusing on manufacturing number, expiry date and quantity.
• Merge reporting milestones into the compliance calendar. This duty runs in parallel with existing item renewal and KGMP periodic review timelines; consolidate them on one sheet, as described in the guide on the Korean post-market compliance calendar.

5. Verification checklist

• □ Applicable start date: check each item’s class against the four year-milestones; every item has passed its start date with no mismatches.
• □ Reporting content completeness: sample the fields of the latest report; it contains all five items — manufacturing number, manufacturing date, expiry date, quantity and date.
• □ Medical institution flow fields: check records flowing to medical institutions; both the distribution amount and unit price are included.
• □ Category definitions: check the mapping of ERP accounts to the five categories; shipment, return, disposal, lease and recall each have an independent account.
• □ Code segment consistency: compare UDI data with the coding rules of the distribution report; the rules agree and no device carries duplicate code segments.
• □ Reporting frequency position: verify the current notices and IMDIS operating requirements; frequency conclusions have sources, and anything without a source is marked as a practical estimate.
• □ Health check records: check the last two health check reports and corrective closures; identified problems were corrected with re-verification records.

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