CP-03License & Import
We review your import & license operating structure for Korea.
Based on your product and sales model, we review the scope of import licensing, sales licensing, and post-market duties, and propose an executable structure. Built for overseas manufacturers without a Korean entity, and for companies that can't staff a dedicated regulatory team.
- Fees
- Quoted after structure review
- Timeline
- Structure review 1–2 wks · registration varies by class
- Included
- Roles & rights fixed by contract · post-market scope agreed
CP-03For Whom
Who this is for
Overseas manufacturers without a Korean entity
You want to enter the Korean market quickly, without incorporating locally.
Startups that can't hire regulatory staff
You want to validate the market and focus on sales without in-house RA/QA.
Distributors carrying regulatory burden
You want adverse-event reporting, recalls, and renewals handled within a contract scope instead of in-house.
CP-03Services & Fees
Services and fees
The import & license operating structure can differ with the product, contract scope, and the outcome of legal review. Specific roles, authority, and post-market boundaries are agreed separately per product and contract — and when the import structure carries too much risk, we recommend direct registration instead.
Structure review
Import & license structure review
We review your product, manufacturer, sales channels, and storage/distribution conditions to determine a workable operating structure for Korea.
Quoted after review
Operations
Operations & post-market support
Maintenance, renewals, and MFDS reporting for the structure, supported within the contract scope. Specific roles and post-market boundaries are agreed per product and contract.
Agreed per product & contract
Offer
We check applicability first, free
Send your product, manufacturer, and sales plan, and we reply within 1 business day on whether the L&I structure applies. If the risk is too high, we'll recommend direct registration under your own name.
CP-03Process
How it proceeds
What happens at each step, and how long it takes — laid out in advance.
01
Structure review request
We take your product, manufacturer, and sales plan and assess whether the L&I structure applies.
Reply in 1 business day
02
Structure review & agreement
Roles, responsibilities, post-market scope, and the contract structure reviewed and proposed — rights defined explicitly in the contract.
1–2 weeks
03
Registration
Import business license, product registration, and KGMP proceed per the agreed structure.
Varies by class
04
Operations & post-market
Adverse-event reporting, recall response, and renewals operated within the contract scope — you focus on sales.
For the contract term
FAQQuestions
Frequently asked questions
Is this name-lending? Is it legal?
No. Nominal name-lending is prohibited under Korean medical device law, and we don't do it. In the L&I structure CLARE Partners is the actual import license holder, personally performing the legal duties that come with it — quality manager operation, post-market surveillance, MFDS reporting. Roles, responsibilities, and rights are written into the contract, and if our review finds the import structure too risky for your product, we recommend direct registration under your name.
How is this different from registering as an importer ourselves?
Direct registration means you satisfy facility, quality-manager, and GMP requirements yourself, and run KGMP/GIP/GSP operations plus adverse-event and recall duties with your own staff. Under L&I, CLARE Partners designs and operates the regulatory and import-management structure while you focus on sales and distribution. The division of roles is defined by contract.
How are our sales rights and accounts protected?
Roles and rights are defined at the contract stage so that your commercial base — accounts, channels, brand — is protected. Specific clauses are settled during contract negotiation.
Does every product qualify for this structure?
No. We review the product, manufacturer, sales channels, and storage/distribution conditions before judging applicability — and when the import structure carries too much risk, we recommend direct registration instead.
Just send the product details.
We do the reviewing.
We pre-review device class, required pathway, and data readiness free of charge, and reply within 1 business day. No sign-up.