Sourced Abroad but Stuck at the Import Licence — Three Routes a Seller Can Take

Key takeaway — Plenty of sellers find a good product abroad and then stop at the import business licence. There are three routes: (1) obtain the licence yourself, (2) buy a device already imported and resell it domestically, (3) place the import licence with a separate holder and focus on selling. The three trade control against requirements and risk. And route 3 turns on one distinction. Current as of September 2026.

Why it stops here

Sourcing is often the easier part — a trade show, an overseas marketplace, or the manufacturer approaching you first.

The problem comes next. "We could import and sell this" and "we can import this" are different statements.

Article 15 of the Medical Devices Act sets the structure:

(1) A person who intends to import medical devices as a business shall obtain an import business licence from the Minister of Food and Drug Safety. (…) (3) A person applying for an import business licence shall at the same time apply for at least one import approval or certification, or file at least one import notification. — Medical Devices Act, Article 15

So the company qualification and the product procedure move as one set. And the licence carries requirements:

• Quality manager — at least one per import business establishment (Enforcement Rule Article 11(1), applied to importers via Article 34)
• Facilities — premises, storage and so on (Enforcement Rule Article 31(1) and Annex 4)
• Quality management system — set by the same annex, together with facilities

What actually blocks people here is the person. Facilities can be solved with money and time; quality manager eligibility cannot. Ten routes are open — more room than most expect (quality manager guide) — but confirming which applies and assembling the evidence takes time.

The three routes

	1. Own import licence	2. Buy domestically and resell	3. Separate licence holder
What you obtain	Import licence + item procedure	Sales business notification	Sales business notification
Requirement burden	Quality manager · facilities · quality system	Notification per establishment	Sales side only
Product choice	Yours	From what is already imported	Yours
Where approval sits	You	The importer of that product	The licence holder
Biggest risk	Failing to secure requirements · upfront cost	Supply stops and so do you	Designing the relationship

These are not ranked but traded. Take control and you carry the requirements; shed the requirements and you give up control.

1. Obtaining it yourself

The most control. You choose the product, the approval is yours, and expanding the line-up later is easier.

In exchange you carry every requirement above, and because the licence and the first item procedure are bound together, the upfront burden lands at once. Details are in the import and customs guide and the Class I import guide.

When this route fits — several products with plans to add more. The requirements are paid for once and then reused.

2. Buying domestically and reselling

Reselling a device already imported into Korea is not importing but the sales business.

The burden is markedly lighter: no review procedure or separate qualification, just notification per establishment. Disqualification grounds still apply (Act Article 17(3)) and distribution quality standards follow after notification (sales business notification guide).

But two things are given up.

First, product choice — you pick from what someone else already imported.

Second, and this matters more — the approval is not yours.

What sellers most often miss

Sign a distribution agreement and the product starts to feel like yours. But item approval, certification and notification attach to the importer that brought it in.

A distribution agreement governs sales rights; it is separate from where the approval sits.

So this happens:

• You spend years opening the market, and the importer changes distributor — the basis for selling disappears
• The importer retires the item and your revenue stops with it
• The accounts and the brand recognition you built have become the asset of whoever holds the approval

Settle it before signing: "if this relationship ends, what do I keep?"

3. Placing the licence with a separate holder

The third route has another company hold the import licence and the item approvals while the seller focuses on selling.

There is one distinction this route hinges on.

A name-only arrangement does not hold. Obligations stay attached to the importer — appointing a quality manager, premises and storage conditions, post-market duties and reporting. Without someone actually discharging them the structure does not stand, and when something goes wrong responsibility cannot be traced.

So there are three questions to put to a licence holder.

1. Do you actually discharge the statutory duties? Is there a quality manager, and who handles post-market work and reporting? A name on paper is itself the risk.

2. Do you also control distribution? This is what separates route 3 from route 2. If the licence holder is also the distributor, route 2's risk returns intact — the relationship ends and selling ends. Where the licence holder stays neutral and does not take part in selling, the registration is not tied to any one sales partner.

3. Are roles and rights written into the contract? Who imports, who carries quality responsibility, how far post-market duties extend, and how your accounts and channels are protected. What is settled verbally does not survive a relationship going bad.

How to choose — the order of judgment

1. How many products, and will the list grow? If it grows, route 1's upfront burden is recovered
2. Can you secure a quality manager? Start with the candidate's eligibility route. The answer forks here
3. Is product choice core to the business? If it is, route 2 does not fit
4. What remains when the relationship ends? Routes 2 and 3 both have to answer this
5. Can you carry post-market duties? Renewal, reporting and adverse event handling continue after issuance

Items 2 and 4 decide it in practice. The rest tend to follow.

What comes with every route

Whichever you choose, the rules attached to selling itself are separate.

• Advertising copy — claims beyond the approved intended use are restricted regardless of medium (advertising rules guide)
• Advertising review — some media trigger prior review (advertising review guide)
• Labelling — Korean labelling has to agree with the original label (labelling guide)
• Post-market — UDI registration, supply reporting, and renewal every five years (renewal guide)

Settling the licence structure and settling how you sell are separate matters; resolving one does not carry the others.

Common mistakes

• Signing for the product first and looking into import requirements afterwards — reverse that order and the contract becomes sunk cost
• Treating a distribution agreement as equivalent to holding the approval
• Not settling before signing what remains when the relationship ends
• Not checking whether the licence holder actually discharges the statutory duties
• Settling the licence structure while deferring advertising, labelling and post-market duties

Before you start

• Map how many products and the expansion plan → judge whether route 1's upfront burden is recovered
• Check a quality manager candidate's eligibility route (including whether evidence can be obtained)
• Confirm item name and class → is the item procedure notification, certification or approval
• For routes 2 and 3, put "what remains when the relationship ends" in writing before signing
• For route 3, confirm the holder's duty performance, distribution neutrality and contractual clarity
• Settle who carries advertising copy, labelling and post-market obligations

---

The answer turns on the product, the number of items and the sales plan. Send a product outline and your sales plan and we will identify which route fits. We operate an import structure ourselves, but where the review shows that structure carries too much risk, we recommend obtaining the licence directly — start at free preliminary review.