Veterinary Medical Device Registration in South Korea — It Is APQA, Not MFDS

Key takeaway — The Medical Devices Act applies to veterinary devices, but Article 46 of the Act delegates the authority to the agriculture side of government. In practice, everything runs on the Regulations on the Handling of Veterinary Pharmaceuticals, etc. and public notices of the Animal and Plant Quarantine Agency (APQA). Same legal root, entirely separate counter and procedure — a human-use approval does not carry over.

Written as of August 12, 2026, based on the Regulations on the Handling of Veterinary Pharmaceuticals, etc. (Ordinance of the Ministry of Agriculture, Food and Rural Affairs No. 741, in force October 31, 2025).

Which law, which authority

Article 46 of the Medical Devices Act delegates authority over devices used for animals to the Ministry of Agriculture, Food and Rural Affairs. The implementing rule is the Regulations on the Handling of Veterinary Pharmaceuticals, etc. (Article 1, based on Article 85 of the Pharmaceutical Affairs Act, Article 46 of the Medical Devices Act, and Article 28 of the In Vitro Diagnostic Medical Devices Act), and the manufacture, import, and sale of veterinary medical devices all follow this rule.

The scope of "veterinary medical device" is itself set by public notice. Article 2 of the Regulations defines it as a medical device intended for animal use designated by public notice of the APQA Commissioner in consultation with the head of the National Fisheries Products Quality Management Service. So the first thing to check is not the class — it is whether your product appears in the designation notice.

Jurisdiction splits by use: livestock and companion-animal devices go to APQA; fisheries-use devices go to the National Fisheries Products Quality Management Service.

Classes and the approval–notification boundary

Classification criteria and procedures are in annexed Table 8 of the Regulations (applying Article 3(2) of the Medical Devices Act). The Class 1–4 system looks familiar, but the boundary between approval and notification sits differently than for human-use devices.

Category	Procedure
Class 2, 3, 4	Product approval
Class 1 — essentially equivalent to an approved/notified item	Product notification
Class 1 — not essentially equivalent	Product approval

Unlike human-use Class 1, where notification is effectively the rule, a veterinary Class 1 item qualifies for notification only when it is essentially equivalent in structure, principle, performance, intended use, and method of use to an item already approved or notified. A first-of-its-kind Class 1 product goes through approval.

Business license structure

As with human-use devices, the company needs its own qualification separate from the product — but the counters differ.

• Manufacturing business license — apply to the APQA Commissioner or the head of NFQS (Article 4)
• Import business license — apply to the APQA Commissioner (Article 19-2)
• Sales/rental business notification — file with the competent si/gun/gu office (Article 23)
• Repair business notification — file with the APQA Commissioner (Article 22-2)

Only the sales/rental notification shares the local-government counter with human-use devices; everything else runs through the quarantine authority.

What are the statutory fees — far lower than for human-use devices

The fees paid to the government are set by Article 56 of the Rules and [Attached Table 4] (amended 5 Jan 2024). The legal basis itself differs from human-use devices, which follow [Attached Table 10] of the Enforcement Rule of the Medical Devices Act.

Item	Veterinary	Human-use (reference)
Item approval, manufacturing or import (per item)	KRW 10,000	Class 1 notification 85,000 · Class 2 certification 130,000 · Class 3–4 approval 719,000
Change approval / notification (per item)	KRW 5,000	—
Import business licence	KRW 30,000	KRW 144,000
Manufacturing business licence (incl. conditional)	KRW 30,000	KRW 144,000
Sales / rental business notification (and changes)	KRW 10,000	KRW 10,000 (same)
Repair business notification	KRW 10,000	—
English certification of approved particulars	KRW 5,000	—

One point deserves emphasis. The veterinary item approval fee is a flat KRW 10,000 per item regardless of class — about one seventieth of the KRW 719,000 charged for a human-use Class 3 or 4 approval.

That does not mean the procedure is lighter. Only the amount paid to the government is small; the real cost and timeline are decided by the branch in the item procedure (a Class 1 device still needs approval without a substantially equivalent precedent) and by the quality requirements. It is why statutory fees and agency fees must be compared as separate lines.

Quality management — separate from KGMP conformity assessment

The facilities and quality management system required of those seeking manufacturing or import approval or notification for veterinary medical devices are set by Article 13-2 (annexed Table 6-5) of the Regulations, with details prescribed by APQA/NFQS public notice.

What matters in practice: the MFDS KGMP conformity-assessment procedure does not apply as such. Even a manufacturer holding human-use KGMP must verify the veterinary requirements separately under this rule. Note that an amended Article 13-2 (amended July 30, 2026) takes effect January 1, 2027 — projects starting next year should prepare against the amended standard.

Change management — a 30-day clock

When a licensed or notified matter changes, a change application (report) must be filed within 30 days of the change (Article 24; product-level approval/notification changes are handled separately). That is a different clock from the 10-day change registration on the human-use integrated information system — companies running both lines should manage the deadlines separately.

Human-use vs veterinary at a glance

Item	Human-use device	Veterinary device
Working rules	Medical Devices Act, Enforcement Rule, MFDS notices	Regulations on the Handling of Veterinary Pharmaceuticals, etc., APQA notices
Authority	Ministry of Food and Drug Safety (MFDS)	APQA (fisheries: NFQS)
Product route	Class 1 notification · Class 2 certification · Class 3–4 approval	Class 2–4 approval · Class 1 notification only if essentially equivalent
Sales business	si/gun/gu	si/gun/gu (same)
Quality standard	KGMP conformity assessment	Article 13-2, annexed Table 6-5 + APQA notices

Traps that come up in practice

Dual-use claims — if the same device claims use for both humans and animals, both procedures apply, each in full. Which use to claim is a labeling-design decision to settle before development or import.

"We have the human-use approval, so we are fine" — no. It is a separate regime, and the reverse also fails: a veterinary approval does not authorize human-use claims.

Skipping the designation notice — the very scope of veterinary medical devices is defined by public notice. Whether your item is in the notice, and in which class, is what determines the procedure and the budget. The skeleton of the registration process follows the same logic as human-use devices, so the medical device registration overview is a useful companion for the full picture.

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CLARE Partners handles veterinary medical device registration with the same technical-file and import-procedure capabilities we use for human-use devices. Send your product details and intended use through a free preliminary review, and we will confirm designation status, class, and the required procedure, itemized.

Source: Korean Law Information Center — Regulations on the Handling of Veterinary Pharmaceuticals, etc. (MAFRA Ordinance No. 741) — original text