Medical Device Standard Code (UDI): Assignment, Data Submission and Deadlines

1. Key takeaways

The legal basis for the medical device standard code (UDI-DI / UDI-PI) in Korea is Article 20 of the Medical Device Act (Act No. 14330, amended December 2, 2016) and Article 54-2 of its Enforcement Rule, with the procedure set by MFDS Public Notice No. 2020-29 (June 12, 2020).

• Code assignment and data submission start by class on 4 dates: Class 4 on July 1, 2019, Class 3 on July 1, 2020, Class 2 on July 1, 2021, Class 1 on July 1, 2022. Data are submitted to the Integrated Medical Device Information System (IMDIS), covering roughly 40 data attributes, of which 15 are auto-filled by MFDS.
• Assignment depth differs by class: Class 1 devices need codes only down to the DI, while Classes 2 to 4 require DI plus PI. The issuing agencies recognized are GS1, HIBCC and ICCBAA; once one is chosen, standards must not be mixed.
• Two obligations are the easiest to miss: whenever uploaded information changes, the database must be modified within 10 days of the change; and supply records must be reported classified by 5 supply types – shipment, return, disposal, rental, and recall.

2. Legal basis

The instruments below ground the UDI obligation, the phased start dates and the supply record reporting duty. Regulatory information verified as of October 29, 2026.

Phased start dates. Code assignment and data submission, and distribution record reporting, each start by class on the dates below.

3. Expert insights

Of the roughly 40 attributes, 15 are auto-filled; the company-side maintenance scope is the remaining 25. IMDIS carries roughly 40 data attributes, of which 15 are auto-filled by MFDS; the rest must be entered and maintained by the licence holder. GRZAN accordingly splits UDI maintenance into two groups – registration-basis fields and distribution-basis fields: the former change with the item licence, the latter with supply activity. The two field groups have different update triggers, and managing them in one undivided sheet inevitably drops items. Registration-basis fields are triggered by item licence changes and distribution-basis fields by actual supply events, and the responsible updaters differ as well.

The 10-day modification duty is a continuing duty, running in parallel with item updates and KGMP periodic audits on three timelines. UDI data must be modified in the database within 10 days of an information change. This duty, together with the 5-year validity of the item update and the 3-year validity of the KGMP certificate, forms a triple overlapping timetable for the licence holder – precisely the problem addressed in Article 50: Korean post-market compliance calendar. In its compliance calendar, GRZAN ties the UDI change trigger directly to the item licence change action, starting the 10-day countdown the moment the change occurs. Once bound, the countdown starts on the day the licence change occurs, not on the day internal approval completes.

Class 1 needs only the DI while Classes 2 to 4 must add the PI, and production line decisions follow from this. Class 1 devices need codes only down to the DI; all other classes need DI plus PI. This difference directly sets the timing and scope of production line modification: for Class 1 products, line-side coding can be deferred to the packaging step, while Classes 2 to 4 require PI generation and recording capability at the packaging station (practical estimate: the specific modification plan depends on the company packaging process). The PI value content must be fixed before coding; serial number, lot number and expiry date are common elements (practical estimate).

One issuing agency out of three, and reimbursement information must be uploaded in the same breath. Three issuing standards are recognized, but the same item must not mix issuing standards. In Chinese manufacturer projects GRZAN most often encounters one company choosing different standards on different product lines, which later makes field formats inconsistent in bulk data upload. The code structures and field lengths of the three standards differ, and mixing them fails outright at bulk upload.

Reimbursement information is a second data set outside the registration basis: when UDI data are uploaded, whether the item is in the reimbursement list and its reimbursement code must be uploaded at the same time. This content is unrelated to the technical content of the item licence; it belongs to the reimbursement basis and is frequently omitted, and the consequence of omission falls on downstream settlement rather than registration validity. When the reimbursement code changes, the UDI data and the settlement information must be updated in sync.

4. Practical recommendations

• Plan code assignment across the item group in one pass. Assign the DI for all models in the item group at once; model-by-model backfilling causes data inconsistency, creates divergent code formats within the same group, and when a new model joins the group the DI must be assigned before data are submitted.
• Bind the UDI change trigger to the item licence change action. The moment item licence information changes, start the 10-day countdown; do not wait for the annual inventory. The item licence change procedure is described in Article 27: Change management – from item-by-item prior approval to a negative list system.
• Report supply records classified by the 5 types. Classify shipments, returns, disposals, rentals and recalls separately, and above all do not omit returns and disposals.
• Fix the issuing standard on the first product and keep it uniform across the product line. Choose one of GS1, HIBCC and ICCBAA, and do not mix standards across product lines once chosen.
• Upload reimbursement information in the same batch as UDI data. Fold the two items – reimbursement list status and reimbursement code – into the same data maintenance sheet, see Article 46: Distribution record reporting and supply detail reporting.

5. Verification checklist

• □ Class start dates: check the phased application table by class; assignment and data submission start dates match the class.
• □ DI / PI scope: determine assignment depth by class; Class 1 DI only, all other classes DI plus PI.
• □ Data attribute entry: check against the IMDIS attribute list; self-entered fields complete, auto-filled fields not mistakenly filled.
• □ Issuing standard consistency: check the issuing agency and code format; only one of GS1, HIBCC and ICCBAA per item.
• □ 10-day change deadline: check change records against database modification dates; database modified within 10 days of the change.
• □ Supply type classification: check shipment, return, disposal, rental and recall records; all 5 types classified and reported, none omitted.
• □ Reimbursement information: check reimbursement list status and reimbursement code; both items uploaded together.
• □ Consistency with container labeling: compare IMDIS data against the container label; item name and standard code identical in both places.

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