Import certification · 2020
Respiratory & anesthesia devices
Technical file and test data review, first-round deficiency response, manufacturer GMP document support
Certified
MFDSMedical Device Market Entry Consulting
We design the market entry structure
before anything else.
CLARE Partners connects medical device registration, manufacturer sourcing, and the import & sales structure into one executable roadmap. Government fees and service fees are itemized separately from the start.
No sign-up · Reply within 1 business day · Free analysis of competing quotes
16+
Completed MFDS registrations
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
Four tracks, one roadmap
From sourcing to registration to the import & sales structure — start at any stage and your documents carry forward to the next. Pick the track closest to your situation.
- Class review
- Manufacturer data check
- Testing · GMP
- Product filing
- Post-market
Already have a quote from another firm? Send it over and we analyze — free — whether government fees are separated from service fees, and whether anything is missing or overcharged.① Pick “Quote comparison” as the inquiry type → ② Paste the quote contents → ③ Reply within 1 business day
Request a free quote analysisCP-00Self-check
Which procedure applies to my product?
Choose your product's class and you can preview the likely approval pathway and procedure in advance. It's fine if you aren't sure of the class.
The procedures, timelines, and documents above are general examples and can vary depending on the product type, product characteristics, and when regulations are amended. They reflect a practical sense of timing based on how ready your materials are, and may differ from the government's statutory processing periods. For an accurate assessment, please confirm through consultation.
RResults
Documents, not claims
Actual outcomes of registrations we performed. Client, manufacturer, and filing numbers are masked; full evidence is shared during consultation.
KGMP conformity letter · 2020
Imaging acquisition device (Class 2)
Initial KGMP audit preparation (facility and quality documents), technical file organization, on-site audit support
Conformity granted
Import notification · 2026
Orthopedic supports & splints
Import business license application review, facility/quality/filing documents, Class 1 import notification
Filed
GGuidelines
Practical guides
Korean approval, certification, and notification procedures organized by device type. If you are preparing a product, start with its guide.
FAQQuestions
Frequently asked questions
How do you lower the chance of deficiency notices?
We pre-check the state of your data and map category-specific review points before filing, so specialists catch gaps and errors in advance. Deficiencies can still occur depending on the product and clinical data — one round of deficiency response is included in the base fee.
What does the service fee include?
The full registration cycle: technical file writing, MFDS filing, review communication, one round of deficiency response, and certificate issuance. Product testing costs, KGMP reviewing-body charges, and overseas certification costs (FDA, CE, etc.) are separate and clearly itemized in the quote.
How long does it take?
It depends on class and readiness. Typically: Class 1 notification 2–4 weeks, Class 2 certification 3–4 months, Class 3 approval 6–8 months. Class 4 can exceed a year when clinical trials are required.
N-00Founder's Note
Hello. I am Yoon Da-ye of CLARE Partners.
There is one thing almost everyone says
when they first look into approval in Korea:
“I don't even know where to begin.”
I felt exactly that when I started out.
So at CLARE Partners I made one principle
non-negotiable: I stay with your case myself,
from the first call to the licence in hand.
Explaining your product again because
the person in charge changed.
A quote where you cannot tell the government
fee from our own.
Waiting on a reply that never comes.
I would rather you never met any of it.
The approvals we have completed,
we show as issued documents.
The costs we quote, we show line by line.
I will not tell you this is an easy road.
I will tell you that you will not walk it alone.
To everyone who has trusted us with an enquiry:
thank you, sincerely.
Yoon Da-ye, CEO, CLARE Partners
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.