Using Korea's Integrated Medical Device Information System — Registration and Supply Reporting

Key takeaway — The Integrated Medical Device Information System is where product and distribution data converge once approval or notification is done. Practitioners do three things here: register standard code (UDI) data together with product and company information (Article 31-3(2) of the Act), update it within 10 days when it changes, and report supply details by the end of the following month (Article 31-2 of the Act; Article 54-2 of the Enforcement Rule). The baseline for the registration deadline is not the date the certificate was issued but the moment before shipment, and supply reporting does not attach to every device — only to those the Enforcement Rule lists. This guide is set out against the statutes and notices in force as of August 2026.

What this system is for

Article 31-3(1) of the Medical Devices Act provides that the Minister of Food and Drug Safety may establish and operate an electronic information processing system in order to efficiently record and manage information on medical devices from approval through manufacture, import, sale, and use, and names that system the Integrated Medical Device Information System. Its operation is entrusted to the Integrated Medical Device Information Center designated under Article 31-4.

The first thing that confuses practitioners starts right here: the name in the statute and the name on the screen are not the same. As confirmed in August 2026, the address udiportal.mfds.go.kr resolves to the MFDS domain emedi.mfds.go.kr, where the header reads Medical Device UDI Tracking Management System. A separate electronic civil petition system for approval and notification filings sits on the same domain, so it pays to fix the distinction early: the place where you filed for approval is not the place where you register codes and file reports.

The menu structure lays out the scope of the system directly.

Menu group	What it does
Basic information	Counterparty management — pre-register the recipients you will name in reports
Supply details	Register report data individually or in bulk, file supply reports, view reporting status, look up item serial numbers and health insurance benefit data
Tracking-managed distribution records	Register manufactured and imported quantities and file distribution records for tracking-managed devices
Inbound/outbound · Recall and disposal	Receipts, shipments, returns, disposal, stock enquiry, recall target enquiry and recall performance
User guidance	Notices, guidelines, related statutes, resources, training, and a directory of commercial software vendors

After you log in, the landing screen shows integrated information registration status (counts of completed, unregistered, and incomplete records by class) and supply reporting status (days remaining until the cut-off this month). Checking what you have not done against these two cards is where the monthly routine starts.

What gets registered — an information set, not a single code

UDI, the medical device standard code, is not one code but a combination of two parts. Article 2 of the notice Guidelines on the Marking and Management of Medical Device Standard Codes defines the standard code as a device identifier (UDI-DI) and a production identifier (UDI-PI).

• UDI-DI — the part generated uniquely per product. This is the code entered into the Integrated Medical Device Information System under Article 31-3(2) of the Act.
• UDI-PI — the part generated per production unit. It carries whichever of the following apply: the manufacturing number (lot or batch number, or serial number), the manufacturing year and month (or the expiry date where one is set), and the version of software used on a standalone basis.

The notice also fixes the unit of generation. Article 4(1) requires the GS1 international standard system to be used per minimum naming unit (by model name, or by product name where one model carries several) and per packaging unit, while Article 8 provides for HIBCC and ICCBBA systems as an exception. How the code is physically applied to the label is covered in mandatory labelling items.

What goes into the system is not only the code. Article 54-3(1) of the Enforcement Rule sets registration targets in three groups — standard code data, product data (including approval, certification, and notification details), and manufacturer and importer data (including the foreign manufacturing site) — and Article 2 of the notice Regulations on the Management of Integrated Medical Device Information enumerates the detailed fields.

Group	Main fields
Standard code data	UDI-DI, barcode system (GS1, HIBCC, or ICCBBA)
Product data	Total quantity per package, management type (lot number, serial number, manufacturing year and month, or expiry date), sterile status and sterilisation method, health insurance benefit eligibility and benefit code, presence of latex or phthalates, MRI exposure safety, implantable and single-use status, item name, classification number (class), approval (certification or notification) number and date, product name, model name, tracking-managed status
Company data	Contact details and email of the integrated information manager, trade name, business licence number, address, the manufacturer where production is outsourced, and the overseas manufacturing site in the case of imports

Storage conditions, the electronic IFU address, and the logistics barcode (Package DI) may be registered optionally where relevant (Article 2(2)), while fields that are linked from the approval information system — item name, class, approval number — may be omitted (Article 2(3)).

The deadlines — there are three

Deadlines are what people get wrong most often. The basis is [Attached Table 7-4] Integrated Medical Device Information Management Standards of the Enforcement Rule (amended 1 July 2026).

Situation	Deadline	Basis
Initial registration	By model name, before shipment following approval, certification, or notification	Attached Table 7-4, item 1(a) and (b)
Change to registered data	Update the registration within 10 days of the change	Same item, (c)
Correction requested by the Center	Act within 20 days of the request	Same item, (e)

One point deserves emphasis. The baseline is not the date the certificate was issued but shipment. If product goes out while registration is still pending, the standards are already breached at that moment. Conversely, if nothing is scheduled to ship yet, you have time. That is why the stock arrival schedule and the registration schedule belong in the same table.

The same attached table also sets ongoing duties: keep registered data current, retain and manage registration records, retain records for three years from the date sales cease where approval, certification, or notification is withdrawn or revoked, provide training to staff, and appoint an integrated medical device information manager (who may also serve as the quality manager). An arrangement in which whoever knows how handles it as it comes up does not meet this standard.

Where a change requires a new standard code to be assigned — a change to instructions for use or to precautions, for instance — the changed information and the new standard code must be registered together (same item, (d)). Because whether a given change requires a change approval, change certification, or change notification is a separate question, change work has to be viewed from the approval side and the integrated information side at once.

Supply reporting — confirm scope first

Article 31-2(1) of the Act requires manufacturers, importers, sellers, and rental businesses to report supply details where they have supplied medical devices to medical institutions, or to medical device sellers or rental businesses. Direct sales to consumers are not on that list. Your standing as a seller is best confirmed together with whether a sales business notification is required.

Separately from the provision that identifies who must report, the scope of devices covered is set by Article 54-2(1) of the Enforcement Rule.

1. Implantable medical devices under Article 12-5(1) of the Enforcement Decree (limited to Class 3 and Class 4) — devices inserted into the body and maintained continuously for 30 days or more
2. Medical devices that are treatment materials eligible for health insurance benefits under Article 8(2) of the Rules on the Standards for Health Insurance Benefits (limited to supply to medical institutions)
3. Other medical devices determined by the Minister of Food and Drug Safety in consultation with the Minister of Health and Welfare

Simplifying this to the idea that delivering medical devices to hospitals always triggers monthly reporting can diverge from the actual scope. Subparagraph 3 allows the scope to be extended, and notices on programme changes continue to be issued, so it is safer to confirm whether your own product is covered against the notice board in the system and the text of the Enforcement Rule.

If it is covered, the deadline is clear. Taking the month of supply as the reference, the supply report in the form at Attached Form 48-2 of the Enforcement Rule is filed through the Integrated Medical Device Information System by the end of the following month (Article 54-2(2)). On screen, the flow is to register counterparties first, upload report data item by item or in bulk via spreadsheet, and finally confirm through the supply report step. If you want to pull the data from your own sales management software, the commercial software vendor directory menu is the starting point.

The same ground from the perspective of a seller who files a Class 1 notification and sells directly is covered separately in Do Class 1 devices also need UDI and supply reporting? If this guide is about how the system works, that one is about which obligations attach to you after notification.

Where practitioners get stuck

• Approval granted, registration never done — item approval or notification and integrated information registration are separate procedures. Cases do arise where approval is outsourced, nobody picks up registration, and shipment starts regardless.
• Reusing a standard code that should have been regenerated — a change to the packaging unit, or to single-use or sterile status, is grounds for regenerating the device identifier (notice, Article 4(2)).
• Letting the 10 days lapse — address, information manager, overseas manufacturing site and similar fields are subject to update even where they fall short of a change to the approval.
• No information manager appointed — Attached Table 7-4 requires one, and the role can be held concurrently by the quality manager.
• Starting without checking whether reporting applies — filing transactions that are out of scope tangles the data, and the reverse omits covered items.
• Agonising over codes for export goods — the standard code notice applies to medical devices distributed and sold domestically, and does not apply to goods for export (Article 3).

Failing to meet the registration or reporting duties makes each of them subject to an administrative fine of up to KRW 1 million under Article 56(1) of the Act. What hurts more than the amount is the way omissions accumulate. Cleaning up after the fact means reassembling past transaction data month by month, and if a counterparty asks for supply history in the meantime, there is no good answer. That is why post-market surveillance is best designed as a monthly routine rather than a one-off event.

What CLARE Partners does

CLARE Partners takes on this recurring post-issuance work, either by item or on a monthly basis.

• UDI standard code registration — standard code generation and registration in the Integrated Medical Device Information System, from KRW 500,000
• Supply reporting (monthly) — from confirming scope through monthly filing, handled on your behalf, from KRW 500,000 per month
• Post-market surveillance outsourcing (monthly) — UDI, change management, and periodic reporting bundled together, from KRW 800,000 per month for Class 1 (Class 2 from KRW 1.7 million; Class 3–4 from KRW 3.5 million)
• Free pre-review — send us the product details and your distribution structure and we will come back within one business day with a first read on the scope of your registration and reporting duties

You can hand over post-market work alone even if the approval was obtained elsewhere. Fees by item are set out under regulatory consulting services.

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The Integrated Medical Device Information System is less difficult than it is leaky, because there are several deadlines. Registration before shipment, an update within 10 days of a change, and the supply report by the end of the following month — fix those three to an owner and a calendar and most of it takes care of itself. To have the registration and reporting scope for your own product checked, send it through for a free pre-review.

Legal basis (as of August 2026): Medical Devices Act of Korea (Act No. 21263, in force 1 Jul 2026) Article 20, subparagraph 8 · Article 31-2 · Article 31-3 · Article 31-4 · Article 56(1); Enforcement Rule of the Medical Devices Act (in force 1 Jul 2026) Articles 54-2 and 54-3 and [Attached Table 7-4] Integrated Medical Device Information Management Standards; Enforcement Decree of the Medical Devices Act Article 12-5(1); Regulations on the Management of Integrated Medical Device Information (MFDS Notice No. 2019-46); Guidelines on the Marking and Management of Medical Device Standard Codes (MFDS Notice No. 2023-67) — based on the official texts at the Korean Law Information Center; contents may change when the statutes are amended.