CP-01Regulatory Affairs
Medical device regulatory consulting that reduces deficiency risk.
We pre-check the state of your product data and build a submission strategy around the actual review points. Repeated deficiency notices stretch timelines and budgets — so we verify data readiness before filing and assign RA/QA/clinical specialists matched to your device category.
- Fees
- Service fee from ₩1.0M
- Timeline
- Class 1: 2–4 wks · Class 2: 3–4 mos · Class 3: 6–8 mos
- Included
- One deficiency round included · government fees itemized
CP-01For Whom
Who this is for
Startups preparing their first device
You don't yet know where to start, how classes are determined, or what budget to plan for.
Importers bringing in an overseas product
You hold home-country approvals but Korea's MFDS process is new — how much of your existing test and clinical data will be accepted, and how the technical file should be written.
Manufacturers who need comparable quotes
Every firm answers “we'll tell you after a consultation.” You need a quote that is itemized and comparable.
CP-01Services & Fees
Services and fees
Service fees, government fees, testing costs, and reviewing-body charges are always itemized separately. Figures are service fees, VAT excluded. Testing costs in particular range from a few million to tens of millions of won depending on the device — we flag the expected range at the pre-review stage.
Registration
Class 1 notification
Low-risk devices. From document preparation to filing.
₩1.0M
Registration
Class 2 certification
Technical file support, MFDS filing, and deficiency responses through certification.
from ₩3.0M
Registration
Class 3 approval
Technical file and clinical data review, MFDS approval filing and deficiency handling.
from ₩6.0M
Registration
Class 4 approval
High-risk devices. Clinical trials, technical files, and full deficiency support, led by a 21-year Class 4 specialist.
Custom quote
Quality systems
Manufacturing KGMP
Quality system documentation, on-site audit preparation and response, through KGMP conformity.
₩4.0M
Quality systems
Import GMP — document review
Document-based GMP review for overseas manufacturing sites, including reviewer communication.
₩2.5M
Quality systems
Import GMP — on-site audit
Preparation and accompanied response for overseas site audits. Travel costs billed at actuals.
from ₩5.0M
Post-market
Post-market retainer (monthly)
UDI, change control, periodic reporting and other post-approval duties, by device class.
Class 1 ₩0.5M · Class 2 ₩1.3M · Class 3–4 ₩2.5M / month
Offer
We analyze competing quotes, free
Send a quote you received elsewhere and we review — at no cost — whether government fees are separated, and whether anything is missing or overcharged. If ours turns out higher, we'll consider matching it.
Offer
30% off the first year when you transfer post-market work
Registered elsewhere? No problem. Transfer only the post-market duties — UDI, change control, periodic reporting — and get 30% off the first year's retainer.
CP-01Process
How it proceeds
What happens at each step, and how long it takes — laid out in advance.
01
Pre-review
We review your product data and determine class, required pathway, and data readiness — free.
Reply in 1 business day
02
Quote & contract
An itemized quote separating government fees from service fees; scope is fixed here.
2–3 business days
03
Document preparation
Technical files, test data, and GMP documents built around category-specific review points.
Varies by class
04
Filing & review response
MFDS and reviewing-body communication, including one round of deficiency response.
Class 1: 2–4 wks · Class 2: 3–4 mos · Class 3: 6–8 mos
05
Issuance & post-market
Certificate issuance confirmed; UDI registration and post-market systems follow as needed.
Ongoing after issuance
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.
Why is KGMP billed separately?
KGMP audits are conducted by designated reviewing bodies (KTL, KTR, etc.), not by MFDS directly — their charges are paid to them, not to us. We prepare the KGMP documentation and handle the audit response.
Can you take over a project started elsewhere?
Yes. We quote only the remaining work after reviewing your existing technical files — first judging what can be reused and what must be rewritten. Transferring only post-market duties is also possible, with 30% off the first year.
What if your quote is higher than others?
Send us the other quote. We analyze it item by item — whether government fees are separated, whether anything is missing or overcharged — free of charge. If ours is genuinely higher, we'll consider matching.
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.