Do Class 1 Devices Also Need UDI and Supply Reporting? — The Obligations That Start After Notification

Key takeaway — Yes, they do. Class 1 earns no exemption. After notification, manufacturers and importers must (1) mark the UDI standard code on the container or outer casing (Article 20, subparagraph 8 of the Medical Devices Act), (2) register the standard code and other product information in the Integrated Medical Device Information System (Article 31-3), and (3) report what they supplied to medical institutions and other sellers every month, by the end of the month following the month of supply (Article 31-2; Enforcement Rule, Article 54-2). Each violation carries an administrative fine of up to KRW 1 million (Article 56).

The certificate arrived — and it is not over?

In an earlier instalment in this series we concluded that the lawful way to use phrases like "therapeutic" or "for medical use" is a Class 1 notification, and that the threshold is lower than people expect. A statutory fee of KRW 85,000, typically 2–4 weeks — all of that still holds.

What remains is the side of the story that begins the day the notification certificate is issued. Medical device registration in Korea is not a one-off procedure that ends with issuance; it is a structure in which maintenance obligations follow the certificate. Measured against a Class 1 notification, three obligations attach immediately.

Obligation	Legal basis	Who bears it	Timing / frequency
UDI standard code marking	Article 20, subparagraph 8	Manufacturers and importers	Marked on the container or outer casing
Registration in the integrated information system	Article 31-3(2)	Manufacturers, etc. (manufacturers and importers)	Register and manage the standard code and other information prescribed by Ordinance of the Prime Minister
Supply reporting	Article 31-2(1); Enforcement Rule, Article 54-2	Manufacturers, importers, sellers, rental businesses	Monthly, by the end of the month following the month of supply

None of the three carries a proviso that says "except Class 1." The class-by-class phase-in from the system's early years is over, and today every class, Class 1 included, is covered. If it is the notification procedure itself you are curious about, see the Class 1 medical device notification guide; for the full picture of procedures, timelines, and costs by class, start with the class-by-class procedure overview.

What the UDI standard code is, and why even Class 1 carries it

UDI (the standard code) is a medical device identification code built so that a product can be traced — which product was made when, and where it went. It consists of a part that identifies the product itself and a part that carries production-unit information (lot, date of manufacture, and so on), and it takes physical form as the barcode on the packaging label.

The law asks for two layers.

First, it goes on the product. Article 20 of the Medical Devices Act sets the items to be marked on the container or outer casing, and subparagraph 8 names the medical device standard code. The marking obligation falls on manufacturers and importers.

Second, it goes into the system. Printing the standard code on the label is not the end of it: the standard code, product information, and the other information prescribed by Ordinance of the Prime Minister must be registered in the Integrated Medical Device Information System (Article 31-3(2)). And when registering and managing that information, the management standards set by Ordinance of the Prime Minister must be followed as well (Article 31-3(3)).

A misconception that surfaces constantly in practice: "we filed the notification, so surely it registered automatically." The product notification and the registration in the integrated information system are separate procedures. Even with the certificate in hand, if UDI generation, label revision, and system registration have not been carried out separately, this obligation is still unfulfilled.

Supply reporting — which sales, reported by when

Article 31-2(1) of the Medical Devices Act requires manufacturers, importers, sellers, and rental businesses that have supplied medical devices to medical institutions or to other sellers or rental businesses to report the supply details to the MFDS (Ministry of Food and Drug Safety). Cycle and method are set by Article 54-2 of the Enforcement Rule — taking the month of supply as the reference, the report goes in by the end of the following month, through the Integrated Medical Device Information System.

From an online seller's point of view, two points deserve a mark.

First, what gets reported is business-to-business supply. The counterparties the provision enumerates are medical institutions and other sellers or rental businesses. Sales made directly to consumers are not in that enumeration. That is why a B2C-only month and a month with a single hospital delivery or wholesale order carry different obligations. The moment a client calls to say they "want to buy in bulk as a business" is exactly the moment to check your reporting obligation.

Second, it is monthly, not once. If approval or notification is a threshold you cross a single time, supply reporting is a deadline that comes back every month. Omissions creep in just as the person in charge leaves or the sales channels multiply. Build, at the outset, a system that extracts the report items from transaction records you already produce — tax invoices, transaction statements — and from then on it becomes repetitive work.

What happens if you don't

Article 56(1) of the Medical Devices Act designates "a person who fails to report medical device supply details or reports them falsely" and "a person who fails to register information in the Integrated Medical Device Information System or fails to comply with the integrated medical device information management standards" as each subject to an administrative fine of up to KRW 1 million.

On the amount alone, that looks lighter than advertising violations, which carry criminal penalties (see the earlier instalment in this series). But the nature differs. Ad copy is fixed once and stays fixed; supply reporting is a monthly obligation, and neglect keeps stacking unfulfilled months on top of one another. Cleaning up late means re-collecting past transaction records month by month and entering them retroactively — and if a business partner (a medical institution, above all) asks to confirm your supply history in the meantime, you have no good answer. In practice, that cost hurts more than the fine.

Turning it into a monthly routine — a three-step self-check

Step 1 — Confirm your role. The scope of your obligations differs depending on whether you are a manufacturer or importer, or a seller. A seller who filed the Class 1 notification directly is a manufacturer or importer: UDI marking and registration plus supply reporting are all yours. If you buy in someone else's product and resell it, UDI registration is the manufacturer's or importer's obligation, and yours is the supply report for the months in which business-to-business supply occurred.

Step 2 — Confirm the UDI registration status. Check in order: has the standard code been generated, has it reached the label, and has registration in the integrated information system been completed? It genuinely happens that only the notification is outsourced, nobody owns UDI, and shipping starts anyway.

Step 3 — Fix the reporting calendar. Anchor the previous month's supply report to the end-of-month deadline in your calendar, and fix the data source (transaction statements, order records) and the owner. Even for months without business-to-business transactions, keeping the step of confirming "nothing to report" is the safer habit.

What CLARE Partners does

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

• UDI standard code registration — generation of UDI standard codes and registration in the Integrated Medical Device Information System handled for you, from ₩0.5M
• Supply reporting (monthly) — the monthly supply reporting obligation handled on a monthly retainer, from ₩0.5M per month
• Post-market management (monthly) — UDI, change management, periodic reporting, and other maintenance work under one retainer, Class 1 from ₩0.8M per month (Class 2 ₩1.7M · Class 3–4 ₩3.5M)
• Free pre-review — send us your product information and sales structure, and we reply within one business day with a first assessment of the post-notification obligations that apply to your case

It is fine if your registration was obtained elsewhere. If you transfer only the post-market management to us, the first year's fee is discounted by 30%. The full per-item fee schedule and how quotations are structured can be found on the regulatory consulting services page.

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If you are preparing a Class 1 notification, the accurate budget is the one that includes the monthly operating costs that follow issuance, on top of the filing fee. Quick definitions of the terms that come up along the way are collected in the glossary — and if you want to know the post-notification obligations for your own product, send it in for a free pre-review and we will confirm the scope.

Legal basis: Medical Devices Act of Korea (Act No. 21263, in force 1 Jul 2026) — Article 20 (Matters to Be Indicated on Containers, etc.), subparagraph 8 · Article 31-2 (Reporting of Medical Device Supply Details, etc.) · Article 31-3 (Establishment of the Integrated Medical Device Information System, etc.) · Article 56 (Administrative Fines), paragraph 1 — and Article 54-2 (Reporting of Medical Device Supply Details) of the Enforcement Rule of the Medical Devices Act. Based on the original Korean texts in the National Law Information Center; the content may change as the legislation is amended.