We review your import & license operating structure for Korea.

You do not have to pick a distributor first

The biggest risk in entering Korea is not the approval itself. It is fixing your partner and your cost structure before you know the market. If you appoint a distributor first and that distributor also holds the import licence and the product approval, weak sales become very hard to reverse.

There is a reason manufacturers end up doing exactly that. To obtain an import licence, a qualified person must be appointed at each import site (Article 11(1) of the Enforcement Rule of the Medical Devices Act; applied to importers under Article 15(6) of the Act and Article 34 of the Rule), and that provision has no proviso. A manufacturer with no Korean entity cannot realistically meet it alone.

When we take that position, starting the approval and finding a partner become two separate tracks.

And that approval belongs to the company that imported it

In Korea, an import product registration is issued in the importer’s name. When your distributor is also the importer, the registration becomes that distributor’s asset — and when the contract ends, the registration ends with it.

Moving to another partner means obtaining the product registration again from the beginning, which takes several months to more than a year depending on the class. When a manufacturer hesitates to replace a distributor, the reason is usually not the partner. It is this structure.

You can still appoint a distributor

There is no reason to avoid a distribution agreement itself. Grant exclusivity with minimum order quantities and performance conditions attached, and make it terminable when those conditions are not met. What makes that termination hard today is that the registration disappears along with it.

The first three lines already work under today’s structure. Only the fourth line changes — and that one line changes what replacing a partner costs.

Use the approval period to find your partner

Approval takes time — several months to more than a year depending on the class. That time is not empty; it is when you look for a partner. With the registration already underway, the conversation with distributor candidates changes: they are evaluating a product whose registration cost and timeline they do not have to carry.

Korean law draws a clear line here — and that line is not a prohibition, it is a point in time.

Advertising the name, manufacturing method, performance or efficacy of a medical device that has not been approved or certified is prohibited under Article 24(2), subparagraph 5 of the Medical Devices Act, and a violation carries up to three years’ imprisonment or a fine of up to KRW 30 million (Article 52(1)). Promotion on the basis of “Korean registration in progress” falls under the same provision where it also carries the product name or a performance claim.

At the contract stage we put this boundary in writing for you, together with the range of wording you can use at each point.

• Medical device advertising rules — prohibited types and self-review

You can start without a distributor at all

A distributor may not be settled by the time approval comes through — or you may decide from the outset not to appoint one. Either way, we take the selling: building a Korea-market brand together with you, listing it on online marketplaces and distribution channels, and running it ourselves. We call this brand build and sales operation.

The brand is yours. You decide the name, the design and the pricing policy; we advise against Korean market norms and execute. Once a distributor is appointed, the channel operation can be handed over or run alongside theirs.

Revenue in Korea starts even without a distributor, and that sales record becomes the argument when you look for the next one. A product that is already selling negotiates on different terms from one that is not.

Included — brand name review, logo and brand guide / product detail pages / marketplace listing requirements and documents / medical device advertising and labelling review / channel operations

Fee — custom quote

You can decide the route to market later

We do not fix a single answer for Korea at the outset. The structure can be chosen — and changed — as you see the product’s fit, the partners’ response and the actual sales.

Eligibility review → structure design → approval and market validation in parallel → route to market fixed → sell and expand. You decide the next investment at the end of each stage, and you can stop or change direction at any of them.

Even if a partner negotiation falls through, the regulatory groundwork and the entry assessment remain. They carry straight into the next negotiation.