Registration abroad, by people who have done it for their own products
We are not a law firm. We are the team that registers the lēfilleo range in new countries, and we do the same work for other Korean medical-aesthetics manufacturers: which markets first, what each regulator needs, and who to work with locally.
Your technology, new possibilities
Brand film · 21 s · EnglishKorean manufacturers
한국어국내 의료기기 제조사를 위한 수출·인허가 안내
해외 시장 진입 검토, 국가별 인허가 준비, 수출 실행 협의. 한국어로 정리한 안내 페이지로 이동합니다.
What we do for a manufacturer
Market-entry plan, registration documents, local representative, labeling and maintenance. The details are below; the first assessment is a conversation, not a contract.
What we do
Market-entry plan
Which countries to register in first, in what order, and a realistic timeline for each.
Registration documents
Technical file review, gap analysis against local requirements, and preparation of the submission package.
Authorized representative and importer
Finding and coordinating the local representative, importer or distributor the registration needs.
Labels and IFU
English and local-language labeling and instructions for use, aligned with the approved claims.
Maintenance
Renewals, change notifications and the records a regulator may ask for later.
From registration to first order
Registration is step one. We connect it to a distributor, physician training and a launch plan.
How an engagement runs
- Product and target reviewYour technical file, your target countries, your timeline.
- Country-by-country assessmentRequirements, classification, local-partner needs and estimated duration for each market.
- ProposalScope, deliverables, schedule and fee for the markets you choose.
- Submission and follow-upDossier preparation, submission through the local partner, responses to regulator queries.
What we do not do
We work in the markets we know. If your target country is one we have not worked in, we say so at the first conversation, and either find a local consultant we trust or tell you we are not the right people. We do not take on a registration to learn on your money.
Who this is for
- Manufacturers of fillers, skin boosters, threads, devices and clinic cosmetics
- Companies with a product approved in Korea and no overseas registrations yet
- Companies with a few registrations that want to add markets without building an RA team
Send us your product and target countries
We reply with a first assessment: what we know about those markets, what it would take, and whether we are the right people for it.
contact@ynymedical.com