FAQFrequently Asked Questions
Medical Device Registration in South Korea — Frequently Asked Questions.
The 31 questions we field most often in consultations, sorted into five groups. The timeframes, amounts, and statutory references in the answers are carried over unchanged from our service pages and practice guides, and where a question deserves more background we have linked the guide that covers it.
Last updated: 2026-07-30
FAQ-01Classification & Process
Classification & Process
How do we work out whether our product is a medical device?
The test is intended use. Article 2 of the Medical Devices Act defines a medical device as a product used for purposes such as diagnosing, treating, alleviating, handling, or preventing disease; diagnosing, treating, alleviating, or correcting injury or disability; or examining, replacing, or modifying structure or function. The practical trap is that the test is what you claim, not what the product can do — the same item raises a medical device question the moment your product page claims one of those purposes.
Read more — Medical device registration in Korea — the full procedure →
Who decides the class?
It follows the MFDS item classification system. You can confirm it against the existing item classification, or where the case is ambiguous have it confirmed through the formal classification procedure. If you proceed on your own reading and the class turns out differently later, the whole procedure starts again.
Read more — Medical device registration in Korea — the full procedure →
How long does each class take?
It depends on the class and on how ready you are. As a general picture, a Class 1 notification takes 2–4 weeks, Class 2 certification 3–4 months, and Class 3 approval 6–8 months; Class 4 can run beyond a year where a clinical trial is required. The state of your documentation and the number of deficiency rounds move these figures.
Read more — Timelines, costs, and required documents by class →
Do Class 1 devices also need MFDS approval?
They are subject to item notification rather than approval. The filing goes through the medical device electronic civil petition portal without MFDS technical documentation review — but the business-level requirements, such as import business licensing, and the labelling duties apply just the same.
Do health and wellness apps need medical device approval?
Intended use is the test. Claim a medical purpose — diagnosing, treating, preventing, or monitoring disease — and the app may be a medical device; claim only exercise or lifestyle management and it may be treated as a non-medical wellness product. The same feature set can land on either side depending on the claim, so fixing the scope of your claims early in development is the safe route.
Read more — Software as a Medical Device (SaMD) — approval guide →
If the reviewer raises deficiencies, how long do we get to respond?
Deficiency periods are normally granted in 30-day blocks, and an extension can be requested with good reason. Note that the deficiency period is excluded from the official processing time, so repeated rounds extend the overall schedule by exactly that much.
Read more — Writing medical device technical documentation →
Are veterinary medical devices also approved by MFDS?
No. Article 46 of the Medical Devices Act delegates authority over veterinary devices to the agriculture ministry, so in practice the work runs under the Rules on the Handling of Veterinary Drugs and through the Animal and Plant Quarantine Agency (the National Fishery Products Quality Management Service for aquaculture use). The Class 1–4 structure is the same, but the line between approval and notification differs: even a Class 1 device needs item approval unless it is substantially equivalent to a device already approved or notified.
Read more — Veterinary medical device registration in Korea →
FAQ-02Cost & Quotation
Cost & Quotation
What does the agency fee cover?
It covers the registration process end to end: drafting the technical documentation, filing with MFDS, handling the review, responding to one round of deficiencies, and obtaining the certificate. Product testing fees, KGMP audit body costs, and overseas certification body costs (FDA, CE and the like) arise separately and are itemised clearly in the quotation.
Read more — Regulatory service fees and the statutory fee table →
Should we avoid a quotation that comes in unusually low?
Price alone will not tell you. What to check is not the amount but the scope. Line up whether statutory fees and pass-through costs are separated, how many deficiency rounds are included, and whether testing and KGMP fall inside the scope — put them on the same basis and the reason for the gap becomes visible. Cheaper at the same scope may be a sound choice; a different scope means the comparison never held in the first place.
Read more — Seven criteria for choosing a regulatory consultancy →
Can we trust a consultancy that guarantees approval?
Approval is decided by MFDS and the review bodies, so no consultancy is structurally able to guarantee the outcome. More useful than a guarantee is a concrete account of how they diagnose the review issues specific to your product in advance, and what procedure they follow when deficiencies come back.
Read more — Seven criteria for choosing a regulatory consultancy →
Can we handle it ourselves without a consultancy?
You can. Class 1 notification in particular is straightforward enough that some companies keep it in house. Where technical documentation review and KGMP enter the picture at Class 2 and above, or where an import case means reassembling documents supplied by an overseas manufacturer, experience in keeping documents consistent with one another is what governs the schedule — and that is where a consultancy earns its place. The dividing line is not whether you have someone to write the paperwork, but whether you have the experience to anticipate review issues.
Read more — Seven criteria for choosing a regulatory consultancy →
Can you review a quotation we received elsewhere?
Yes. Send it over and we will analyse it line by line — whether government fees and agency fees are separated, whether anything is missing, and whether anything is over-charged — free of charge, and report back. If our analysis says we are the more expensive option, we will look at matching the quotation.
Read more — Regulatory service fees and the statutory fee table →
Can you take over a project already under way elsewhere?
Yes. We quote for the remaining work according to how far it has progressed, after first reviewing the existing technical documentation and materials to judge what can be used as is and what has to be rewritten. You can also hand over post-market work alone where the registration was obtained elsewhere, and we discount the post-market fee by 30% for the first year.
Read more — Regulatory service fees and the statutory fee table →
FAQ-03KGMP & Quality
KGMP & Quality
Why is the KGMP audit charged separately?
Because the KGMP (Korean Good Manufacturing Practice) audit is carried out by a separate audit body — KTL, KTR and others — rather than by MFDS. The audit body's fee is paid directly to that body and does not pass through the consultancy. What we do is prepare the KGMP documentation and handle the audit.
Can KGMP run in parallel with technical documentation review?
Yes, and preparing them in parallel is the key to a shorter timeline. KGMP is bound up with item certification and approval: to ship and sell the product, conformity for that manufacturing site has to be in place. Filing the technical documentation and then waiting for the KGMP audit in sequence stretches the overall schedule by exactly that gap.
Our overseas manufacturer holds ISO 13485 — does that exempt us from KGMP?
It does not. ISO 13485 is an excellent foundation for KGMP preparation, but KGMP is a separate conformity procedure against Korean requirements. That said, a site with a well-run 13485 system faces a far smaller documentation gap analysis and far less remediation.
Class 1 does not need KGMP, correct?
A large share of Class 1 items are outside the scope of KGMP conformity, but some — sterile products among them — are exceptions. Whether your item falls into one of those exceptions has to be confirmed before you file the notification.
Does software as a medical device also go through a KGMP audit?
Yes. A quality management (KGMP) audit is required separately from approval or certification. In place of a physical production line, the audit centres on software development, configuration management, and maintenance processes, and IEC 62304-based development lifecycle documentation feeds straight into it as evidence.
Read more — Software as a Medical Device (SaMD) — approval guide →
How is KGMP preparation split between the importer and the overseas manufacturer?
The bulk of the quality system documentation and the on-site audit response sits with the manufacturer. The importer conveys the Korean requirements, assembles the documents, files for the audit and manages the schedule, and owns the quality procedures for the domestic distribution stage. Leave this division of roles out of the contract and the project stalls somewhere in the middle.
FAQ-04Import & Overseas
Import & Overseas
Does holding CE marking exempt us from Korean registration?
No. There is no mutual recognition agreement between CE and MFDS, so selling in Korea means going through notification, certification, or approval separately according to class. That said, the test reports and technical documentation produced for CE can be reused in the Korean review where the conditions are met.
Read more — CE marking and Korean approval — how they relate →
We have overseas test reports — does that mean no Korean testing?
Not quite. Some items are accepted (electrical safety, EMC and the like) and others have to be retested (performance testing and some biological testing among them). The reliable route is to build an inventory of what you hold and run a gap analysis against Korean standards to separate what survives from what has to be tested afresh.
Read more — When overseas test reports are accepted in Korea →
Which countries do you support for overseas registration?
Beyond the US FDA and EU CE MDR, we support registration in Canada (Health Canada), China (NMPA), Japan (PMDA), Thailand (Thai FDA), and Singapore (HSA). Where a local representative, testing house, or certification body has to be involved, CLARE Partners runs the overall project as your single point of contact in Korea and works with specialist partners in the target market.
What is the difference between an import business licence and item notification, certification, or approval?
The import business licence is about your company's standing to import medical devices; the item procedure is about whether this particular product may be imported. You need both, and completing the item paperwork without the business licence stops you at the filing stage.
What do we do if customs puts the goods on hold?
Pinning down the reason for the hold comes first — an unmet requirement, a labelling problem, a mismatch between documents. The response diverges accordingly: remedying the requirement, rework, or return of the goods. Storage charges accrue daily, so identifying the reason and deciding the response quickly is what keeps the loss small.
Why should registration be considered as early as the sourcing stage?
Two products with the same function can differ on whether Korean registration is achievable, depending on the manufacturing site's quality system and the standard of its test data. Discover a mismatch with registration requirements after selecting the manufacturer and sourcing starts over from the beginning. CLARE Partners assesses registration suitability while candidates are still being reviewed.
Is the licence and import (L&I) structure just lending us a name?
No. Lending a name in form only is not permitted under the Medical Devices Act, and we do not do it. Under the L&I structure CLARE Partners is the actual holder of the import business licence and directly performs the statutory duties — operating the quality manager function, post-market management, and reporting to MFDS. Roles, responsibilities, and rights are set out expressly in the contract, and where our review finds the import structure carries too much risk for a given product, we recommend registration in the client's own name instead.
FAQ-05Post-market
Post-market
Are UDI standard code registration and supply reporting separate from customs clearance?
They are separate obligations. Even after clearance, the importer must register the standard code and product information in the Integrated Medical Device Information System, and where the item is within reporting scope, supply details must be reported by the end of the month following the month of supply. Clearance is not the finish line — it is where the distribution management duties begin.
Which changes count as minor changes?
Changes that do not affect the performance or safety of the product, and that MFDS has listed in the attached tables to the Regulations on Approval, Notification, and Review of Medical Devices. Exterior colour and packaging design changes are typical examples — but the same colour change can be judged differently where it concerns a body-contacting part, so each item has to be checked against the attached table and the decision flowchart.
Read more — Change approval, change certification, and change notification →
If the overseas manufacturer changes, is notifying enough?
No. Changing or adding a manufacturing site is normally subject to change approval or change certification review, and a KGMP audit of the new site may be required alongside it. Mistaking it for a simple notification and importing first makes it an unauthorised change, so review before you sign the contract.
Read more — Change approval, change certification, and change notification →
If we retrain an AI model and performance changes, do we need approval again?
Changes affecting intended use or performance are normally subject to change approval and review. For AI software where retraining and algorithm revision are frequent, the practically important step is to design the change control criteria at the approval stage — settling in advance where minor change ends and review begins.
Read more — Software as a Medical Device (SaMD) — approval guide →
What happens if a non-medical product is advertised like a medical device?
Article 26(7) of the Medical Devices Act prohibits labelling or advertising that is liable to mislead people into believing that something which is not a medical device has performance or efficacy similar to one, and it also prohibits selling or displaying a product so labelled or advertised. A violation can draw imprisonment of up to three years or a fine of up to KRW 30 million under Article 52 of the same Act, and the two may be imposed together.
Read more — Where general goods end and medical devices begin — online listings →
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