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 ₩0.5M
- 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
Figures are minimum service fees (“from”), VAT excluded. The final amount is fixed in an itemized quote based on device complexity, number of models, and the state of your data. Government statutory fees are disclosed below; reviewing-body charges (technical file review, KGMP) and testing costs are separate actual costs paid directly to those bodies and are shown as separate lines in the quote.
Registration
Class 1 notification
Low-risk devices. We handle everything from preparing the required documents to filing the notification.
from ₩2.0M
Registration
Class 2 certification
The full certification procedure, including technical file drafting support, MFDS filing, and deficiency responses during review.
from ₩6.0M
Registration
Class 3 approval
Technical file and clinical data review, MFDS approval filing, and all deficiency responses.
from ₩9.0M
Registration
Class 4 approval
High-risk devices. Full-scope support across clinical trials, technical files, and MFDS deficiency responses. A Class 4 specialist consultant in their 21st year is assigned.
from ₩15.0M
Registration
Veterinary medical device approval / notification
Veterinary devices fall under the Animal and Plant Quarantine Agency, not MFDS. We cover the item procedure (even Class 1 needs approval where there is no substantially equivalent precedent), the import business licence, and the quality requirements set by the Rules on the Handling of Veterinary Drugs.
Custom quote
Business licensing
Import & manufacturing business licence
We prepare and file the import or manufacturing business licence application, including review of facility and quality manager requirements.
from ₩2.0M
Business licensing
Sales (rental) business notification
We prepare and file the medical device sales or rental business notification.
from ₩0.5M
Changes & renewals
Change approval & change review
We handle the change approval and change review procedures for amendments to approved or certified items — model additions, specification and labelling changes.
from ₩2.0M
Changes & renewals
Product approval renewal
We prepare the renewal application required under the approval renewal system and handle filing and deficiency responses.
from ₩2.0M
Quality systems
Manufacturing KGMP
Quality system documentation, on-site audit preparation and response, through to KGMP conformity recognition.
from ₩8.0M
Quality systems
Import GMP — document review
Response to the document review of an overseas manufacturing site's GMP, including preparation of the submission documents and communication with the reviewing body.
from ₩6.0M
Quality systems
Import GMP — on-site audit
Preparation for and accompanied response to overseas site audits. Airfare and accommodation are billed separately at actuals.
from ₩9.0M
Quality systems
GMP mock audit & periodic audit response
Mock audits ahead of the periodic (renewal) audit, internal and supplier audits, and audit response — supported by scope.
from ₩4.0M
Quality systems
Usability engineering (IEC 62366)
We support the usability evaluation plan and report, and the review response.
from ₩8.0M
Quality systems
Software validation & risk management
We support medical device software validation (IEC 62304) and risk management documentation (ISO 14971).
Custom quote
Testing & overseas certification
Testing coordination & management
Test item design, comparison of laboratory quotes and placement of orders, and test report management. Testing charges are billed separately at the laboratory's actual cost.
from ₩2.0M
Testing & overseas certification
Overseas certification — US FDA 510(k)
We support US FDA 510(k) strategy and technical file preparation. FDA fees are separate.
Custom quote
Testing & overseas certification
Overseas certification — EU CE MDR and others
We support the technical file and review response for overseas certifications such as EU CE MDR. Notified body review charges are separate.
Custom quote
Testing & overseas certification
Insurance listing (reimbursement) consulting
We review and support the national health insurance listing (reimbursement) procedure after registration.
Custom quote
Post-market management
Post-market retainer (monthly)
Post-approval maintenance work — UDI, change control, periodic reporting — outsourced on a monthly basis by device class.
from ₩0.8M (Class 1) · ₩1.7M (Class 2) · ₩3.5M (Class 3–4) per month
Post-market management
UDI standard code registration
We generate the UDI standard codes and register them in the Integrated Medical Device Information System.
from ₩0.5M
Post-market management
Supply record reporting (monthly)
The medical device supply record reporting that is mandatory every month, handled on a monthly retainer.
from ₩0.5M / month
Post-market management
Advertising pre-review
We draft the medical device advertising pre-review application and handle the review response. Review fees are separate.
from ₩0.5M
Post-market management
Labelling review
We review the labelling on containers, packaging, and package inserts against statutory requirements.
from ₩0.5M
Government statutory fees
Enforcement Rule of the Medical Devices Act [Annex 10] · amended 1 July 2026 · electronic filing basis
- Class 1 manufacturing/import notification
- KRW 85,000
- Class 2 manufacturing/import certification
- KRW 130,000
- Class 3–4 manufacturing/import approval (incl. technical file review)— KRW 1,495,000 when clinical data review is included
- KRW 719,000
- Manufacturing / import business licence
- KRW 144,000 each
- Sales (rental) business notification
- KRW 10,000
- Approval / certification / notification renewal
- KRW 500,000 · 430,000 · 100,000
These are the statutory fees payable to MFDS (the Korea Institute of Medical Device Safety Information). The Class 2 technical file review fee and the KGMP audit fee are separate actual costs set by the published rates of the reviewing bodies (KTL, KTR, etc.); together with testing costs they are shown as separate lines in your quote. Amounts may change when the regulations are amended.
Offer
We review the scope of the quote you received, free
Send us a quote you received elsewhere and we will review it at no cost — whether government and reviewing-body fees are separated from the service fee, what the service scope covers and what is billed separately, and any missing or over-billed items — then walk you through the result. If the review shows we are the more expensive option, we will consider a matching quote.
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.