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

1. Classification · even Class I does not settle the route

Whether a product is a veterinary medical device is decided by notice. Whether it is regulated at all is settled only once you confirm that it is designated in the Regulation on the Scope and Classification of Veterinary Medical Devices.

Class comes next, and this is where human-use instinct misleads. On the veterinary side Classes II–IV are product approvals, and Class I is a notification only when the product is “substantially equivalent in structure, principle, performance, intended use or method of use, etc.” to a product already approved or notified.

A schedule and budget built on “Class I, so notification” is thrown off from the start if the route turns out to be approval. Checking the class is not enough; precedent has to be checked too.

A product whose classification takes a long time to decide, such as a newly developed device, may be given product approval, or have its notification accepted, under a mid-level category name or a separately set product name (Regulation on the Approval, etc. of Veterinary Medical Devices, hereafter the Approval Notice, Art. 3(5)).

An application to reclassify a product's class is reviewed and decided by the Commissioner of APQA within 60 days (Rules Annex 8).

• Read the full guide to veterinary medical device approval

2. The filing office · only sales and rental notifications go to the local office

Import licences and repair business notifications are received by the Commissioner of APQA. The manufacturing licence provision (Rules Art. 4) applies jointly to veterinary drugs, quasi-drugs, medical devices and in vitro diagnostic devices, so the table carries the provision's own wording, “Commissioner of APQA or of NFQS”.

Manufacturing, import and sale of veterinary medical devices sit with the Commissioner of APQA (Rules Art. 2-2). The import licence application carries a statement of facilities and equipment and the product's import approval application or notification; an applicant that is not a corporation also attaches a doctor's medical certificate issued within the past 6 months (Art. 19-2).

Online filing goes through APQA's veterinary drugs portal, 동물용의약품 아지(AZ)트 (filing by internet, in person or by post; viewed 6 Oct 2026).

The same guidance describes the import licence as issued after a check of the application and submitted documents and an on-site inspection against the statement of facilities and equipment.

3. Quality · separate from the MFDS KGMP conformity assessment procedure

Facilities and the quality-management system are set by Article 13-2 and Annex 6-2 of the Rules on Handling Veterinary Drugs, with the detail fixed by notice of the Commissioner of APQA or of NFQS.

The “standard for good manufacturing and quality-management systems” in Annex 6-2 is what a manufacturer puts in place when it seeks to be covered for export purposes.

The Manufacturing and Quality Control Standard for Veterinary Medical Devices and Veterinary IVDs for Export (APQA Notice No. 2024-8) likewise states that it does not apply where the purpose is domestic sale.

A site holding human-use KGMP is at an advantage, that much is true. But a quality-system review procedure for products sold domestically (the counterpart of MFDS KGMP conformity assessment) is not separately set out in the Rules or in the three APQA notices we compared (confirmed 6 Oct 2026).

The requirements themselves exist, so the first task is mapping the documents you hold against the Annex 6-2 standard to see how much of them can be used.

The annex number becomes 6-5 under the amendment promulgated 30 Jul 2026 and in force from 1 Jan 2027, but the text is the same (compared 6 Oct 2026).

After approval, manufacturers and importers must still comply with the Annex 6-2 standard (Rules Art. 22(1) no. 15). There is also the duty under Art. 13-2(3) to have test facilities and product-specific quality-control standards.

4. Documents and processing time · what to have before filing, and the days that run after it

An import product approval carries documents stating the product name, class, shape and structure, raw materials, test specifications and the like; the technical file and safety-and-effectiveness review documents; and a test report issued by a testing body designated by the Minister of Agriculture, Food and Rural Affairs (Rules Art. 16 and Art. 5).

Add a manufacturing certificate from the government of the producing country (including bodies it has delegated or entrusted) and a sales certificate from the government of the country of approval or registration, each issued within 2 years before the application date. An import notification for an equivalent Class I device carries the document stating the product name and so on, plus either the certificates or documents that can prove the same content.

Test-data requirements are set by Article 6(2) of the Regulation on the Review of Technical Documents, etc. for Veterinary Medical Devices (hereafter the Review Notice). It covers the supporting data for everything from electrical and mechanical safety to test specifications, and for the development history, stability and clinical trial data.

That supporting data must fall under one of the nine subparagraphs of Article 6(2), and test data must share the model name and raw-material list of the product applied for and conform to Annex 2 of the notice.

Technical-documentation review is applied for to, and conducted by, the Commissioner of APQA. Supplementation may be requested once only, within a period set at up to 60 days; where the applicant requests an extension stating a period, the period may be set in light of the reasons (Review Notice Arts. 5 and 7).

For Class I and II products, clinical trial data may be replaced by clinical data (clinical data on an approved or notified device with equivalent characteristics, SCI papers and the like); from Class II upward, a substantial-equivalence comparison table is used to review the product as new, improved or equivalent (Review Notice Arts. 3 and 6).

The test report under Rules Art. 5(3) no. 2 (c) is issued by a testing body designated by the Minister of Agriculture, Food and Rural Affairs. An overseas report can be reviewed and recognised by the head of the testing body only if it was issued by a body named in Article 23 of the Approval Notice.

Those bodies are: testing bodies designated by the Minister of Agriculture, Food and Rural Affairs; medical device testing bodies designated by the Commissioner of the Korea Food and Drug Administration (as the text reads); bodies issuing test data under the Review Notice; and bodies with a mutual recognition agreement with the first two. Where only some items are recognised, the rest are tested.

Processing times are as stated in the Government24 service guidance, counted in days including the filing date and excluding Saturdays and public holidays (viewed 6 Oct 2026).

This is not the schedule you will experience. Time to prepare the required documents such as test reports, and to respond to technical-documentation supplementation requests, must be budgeted separately.

The table shows processing time only. Statutory fees are in the fee table below; testing fees and our service fee are separate.

Where the producing country has no product approval system, or a different one, and the manufacturing and sales certificates cannot be produced, supporting evidence issued by the government of the manufacturing country or the relevant underlying regulation is submitted instead (Approval Notice Art. 5).

Test data more than 3 years past its issue date is accompanied by material confirming that the product has not changed since issue (Review Notice Art. 6(2)).

Overseas reports are recognised only for test results obtained by a test method at or above the level recognised by the Commissioner of APQA (Approval Notice Art. 23(2)).

• Request a preliminary review with your product documents and list of test reports