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CLARE Partners
Pre-review

CP-04Veterinary Medical Devices

The route runs through APQA, not MFDS — and we work it as it is.

Veterinary medical devices sit under the Medical Devices Act, but the authority is delegated to the agriculture ministry, so the regulator, the procedure and the quality requirements all diverge from the human-use track. The four-class scheme is the same, yet a Class I device still goes through approval unless a substantially equivalent product is already registered, and the quality requirement is not MFDS KGMP conformity but the standard set in the Rules on Handling Veterinary Drugs. We work this track with the technical-file and import expertise we use on the human-use side.

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Fees
Quoted after preliminary review
Timeline
Scope & class within 1 business day · route varies by precedent
Included
Scope check · class · approval-vs-notification route

CP-04For Whom

Who this is for

Importers bringing in overseas veterinary devices

Even the office that receives your import licence application is different. Whether the product falls inside the designated scope, and whether it goes to approval or notification, has to be settled before you sign.

Companies that already hold human-use approvals

A human-use approval or KGMP certificate does not exempt the veterinary side. Relevant when you intend to market the same device for animal use as well.

Manufacturers entering the veterinary clinic market

You are walking the whole track for the first time — from product classification and class to the business licence structure.

CP-04Structure

Where human-use experience helps — and where it does not transfer

Because veterinary sits on the Medical Devices Act, the logic of the regulatory work is the same. Human-use experience is an asset — but it works only when it is used to know what to check, not to reuse documents. Practice diverges in three places.

1. Classification — Class I does not settle the route

The scope of what counts as a veterinary medical device is set by notice. You confirm whether the product is designated before anything else, because that is what decides whether it is regulated at all.

Class comes next, and this is where human-use instinct misleads. On the human-use side the class fixes the route. On the veterinary side Classes II–IV are product approvals, while Class I qualifies for notification only when it is substantially equivalent to a product already approved or notified. A Class I device with no precedent goes through approval.

A schedule and budget built on “Class I, so notification” collapses if the route turns out to be approval. Checking the class is not enough — you have to check precedent.

2. The filing office — three of the four are APQA

ProcedureFiled withBasis
Manufacturing licenceCommissioner of APQA, or of NFQS for aquaculture useRules Art. 4
Import licenceCommissioner of APQARules Art. 19-2
Repair business notificationCommissioner of APQARules Art. 22-2
Sales / rental notificationLocal mayor or district headRules Art. 23

Only the sales and rental notification goes to the local office, as it does for human-use devices; the rest sit with APQA. For aquaculture use the office shifts again, to the National Fishery Products Quality Management Service.

3. Quality — this is not KGMP conformity assessment

Facility and quality-system requirements are set by Article 13-2 (Annex 6-5) of the Rules on Handling Veterinary Drugs, with the detail fixed by notices from APQA and NFQS. The MFDS KGMP conformity assessment procedure does not simply carry over.

Holding human-use KGMP does help. But the work is not submitting the existing documents as they are — it is mapping them against this standard first, to see how much of them can be used.

The amendment to Article 13-2 dated 30 July 2026 is scheduled to take effect on 1 January 2027. Projects starting next year are safer prepared against the amended standard.

CP-04Services & Fees

Services and fees

Veterinary procedures branch with the product, its class and whether precedent exists, so we price after a preliminary review rather than quoting a flat figure. Government statutory fees are separate and shown as a separate line in the quotation. VAT excluded.

Device registration

Veterinary product approval / notification

We confirm whether the product falls within the designated scope, review precedent for substantial equivalence to fix the approval-or-notification track, then prepare and file the dossier.

Custom quote

Business licence

Veterinary import / manufacturing licence

We prepare and file the business licence application submitted to the Commissioner of APQA. Sales and rental notifications are handled separately, filed with the local city or district office.

Custom quote

Quality systems

Veterinary quality requirements

We review facility and quality-system requirements against Article 13-2 and Annex 6-5 of the Rules on Handling Veterinary Drugs together with the APQA notices, and identify how far existing human-use KGMP documentation can be reused.

Custom quote

Post-market

Veterinary change management

We file changes to approved or notified particulars within the 30-day deadline. That clock differs from the human-use UDI system deadline, so we keep the two schedules on separate trackers.

Custom quote

Government statutory fees (veterinary)

Rules on Handling Veterinary Drugs, Annex 4 · amended 5 Jan 2024

Manufacturing / import product approval (per product)— Flat, regardless of class
KRW 10,000
Change to product approval / notification (per product)
KRW 5,000
Import licence — veterinary devices & IVDs
KRW 30,000
Manufacturing licence (incl. conditional)
KRW 30,000
Sales / rental notification (and changes)
KRW 10,000
Repair business notification
KRW 10,000
Reissue of a licence or registration certificate
KRW 1,000
English certification of approved particulars
KRW 5,000

Statutory fees paid to APQA (or to the National Fishery Products Quality Management Service for aquaculture use). Unlike human-use devices at KRW 85,000–719,000 depending on class, a veterinary product approval is a flat KRW 10,000 per product regardless of class. That means the amount paid to the government is small — not that the procedure is light. Actual cost is driven by the difficulty of the product route and by meeting the quality requirements. Testing fees are separate pass-through costs and appear as their own line in the quotation. Amounts may change when the rules are amended.

Offer

We check the designated scope first, free

The scope of what counts as a veterinary medical device is itself set by notice. Send the product documents and the claims you intend to make, and we reply within 1 business day on whether it falls in scope, its likely class, and whether it goes to approval or notification.

CP-04Process

How it proceeds

What happens at each step, and how long it takes — laid out in advance.

  1. 01

    Scope & class check

    We confirm whether the product is designated as a veterinary medical device by notice, and what class it falls in. This is what sets the size of the procedure and the budget.

    First reply within 1 business day

  2. 02

    Fixing the route

    For a Class I device we review precedent — structure, principle, performance, intended use and method of use — to judge whether notification is available.

    Varies by product

  3. 03

    Business licence in parallel

    Import and manufacturing licences are filed with APQA; sales and rental notifications go to the local office. We run these alongside the product procedure.

    Parallel to the product route

  4. 04

    Quality requirements

    We review facilities and the quality system against Article 13-2 and Annex 6-5, and separate out what can be carried over from existing human-use KGMP.

    Varies by site

  5. 05

    Post-approval change management

    Changes to approved or notified particulars are filed within 30 days. If you also run human-use products, we keep the deadline trackers separate.

    Monthly retainer available

FAQQuestions

Frequently asked questions

Are veterinary medical devices approved by the MFDS?

No. Article 46 of the Medical Devices Act delegates authority over veterinary use to the agriculture ministry, so in practice the work runs on the Rules on Handling Veterinary Drugs and the standards of the Animal and Plant Quarantine Agency (APQA) — or the National Fishery Products Quality Management Service for aquaculture use.

Does a human-use approval exempt the veterinary side?

It does not. They are separate regimes, and the reverse holds too — a veterinary approval does not let you make human-use claims. If you market the same device for both people and animals, you need both procedures, so which side you claim is a labelling decision to settle before development or import, not after.

Is Class I just a notification?

Not on the veterinary side. Notification is available only where the device is substantially equivalent to an already approved or notified product in structure, principle, performance, intended use and method of use. A Class I device with no precedent goes through approval. Because a schedule and budget set on the notification assumption will shift if the route turns out to be approval, checking the class is not enough — precedent has to be checked too.

Does human-use KGMP satisfy the quality requirement?

Not as it stands. Facilities and the quality system are governed by Article 13-2 (Annex 6-5) and by APQA and NFQS notices, and a manufacturer holding human-use KGMP still has to verify the veterinary requirements separately. Note that the amendment to Article 13-2 dated 30 July 2026 is scheduled to take effect on 1 January 2027, so work starting next year is safer prepared against the amended standard.

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.

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+82-70-7954-1254 ·