CP-01
Regulatory Affairs
MFDS notification, certification, and approval for Class 1–4 devices — technical files, testing coordination, KGMP, and deficiency responses, run by consultants matched to your device category.
MFDSKorea Medical Device Market Entry
Enter the Korean market —
without a Korean entity.
CLARE Partners designs and operates the regulatory side of your Korea entry — MFDS registration, KGMP, and the import structure — while your product, brand, and sales channels stay 100% yours.
Reply in English within 1 business day · No sign-up · Itemized quotes
16+
MFDS registrations completed
Class 1–4
Scope · completed track record in Class 1–3
8+ yrs
Minimum consultant experience
1
Point of contact — a dedicated PM
CP-00Services
Three tracks, one roadmap
Start at any stage — sourcing, registration, or import structure — and the work carries forward without re-doing documents.
CP-02
Manufacturer Sourcing
Finding and vetting contract manufacturers in Korea and Asia against the regulatory data they will actually need to produce — so sourcing decisions don't come back as registration problems.
CP-03
License & Import
For overseas manufacturers without a Korean entity: CLARE acts as your Korean license holder and importer of record, operating the regulatory and quality obligations while you keep the market.
CP-03License & Import
A license holder, not a middleman
Name-lending is illegal in Korea — and unnecessary. CLARE Partners acts as the actual importer of record, performing the legal duties that role carries, under a contract that keeps the market yours.
You keep
- Your product, brand, and IP
- All sales channels and distributors
- Customer relationships and pricing
CLARE handles
- MFDS registration under our importer license
- Quality manager, post-market duties, MFDS reporting
- Import operations and license maintenance
Put in writing
- Roles, responsibilities, and liabilities
- Your distribution rights protected by contract
- Exit terms — including license transfer paths
PProcess
From first email to first shipment
- 011 business day
Free pre-review
Send product details; we assess class, pathway, and data gaps.
- 022–3 days
Itemized quote
Government fees, testing costs, and our fees — listed separately.
- 03Class-dependent
Structure & filing
Contract, technical file, testing, KGMP, MFDS submission.
- 04Ongoing
Import & post-market
Import operations, reporting, and license maintenance.
FFees
Priced like a ledger, not a pitch
Every quote separates three things: government fees, testing costs, and our service fee. Figures below are service-fee starting points.
Class 1
Notification
Low-risk devices. Document review, filing, and listing.
from ₩1.0M
Class 2
Certification
Technical file, testing coordination, and deficiency response (one round included).
from ₩3.0M
Class 3
Approval
Higher-risk devices including clinical data review and MFDS approval.
from ₩6.0M
KGMP
Quality system
KGMP documentation and audit support for the manufacturing site.
from ₩4.0M
Excludes VAT. Government and testing-lab fees are itemized separately in every quote — testing costs in particular range from a few million to tens of millions of won depending on the device, so we flag the expected range at the pre-review stage, before you commit to anything.
RResults
Issued documents, not claims
Masked copies of actual MFDS licenses, certifications, and KGMP letters we obtained. Client and manufacturer names stay confidential; full evidence is shared during consultation.
16+ documents in the archive — browse all (Korean page)
FAQQuestions
What overseas teams ask first
Do we need a Korean subsidiary to sell in Korea?
No. Korean law requires a local license holder and importer of record — not a subsidiary you own. Under the License & Import model, CLARE Partners holds the import license and performs the legal obligations that come with it, while your distribution agreements secure the market for you. If our review finds this structure risky for your specific product, we will recommend direct registration under your own entity instead.
Who owns the license, and is our market position protected?
The MFDS registration is held by CLARE Partners as the actual importer — this is not a name-lending arrangement, which Korean law prohibits. We operate the quality manager role, post-market surveillance, and MFDS reporting in practice. Your sales rights, territory, and exit terms (including how the license position is handled if we part ways) are fixed in the contract before anything is filed.
Can our FDA / CE data be reused?
Partially, and it depends on the device. Test reports, clinical data, and quality system documents can often be leveraged for the Korean technical file, but MFDS has its own testing and format requirements. The free pre-review tells you what carries over and what must be produced new — before you spend anything.
How long does registration take?
Rough planning figures: Class 1 notification 2–4 weeks; Class 2 certification 3–4 months; Class 3–4 approval 6 months or more, driven mostly by testing and clinical requirements. Timelines are confirmed per product at the quote stage.
CPre-review Request
Send the product.
We’ll map the pathway.
The pre-review is free: device class, required pathway, reusable data, and a realistic timeline — replied in English within 1 business day.
Prefer email? Write to . Same review, same reply time.