Preparation of documents for veterinary medical device import business, item approval, and item notification, and coordination with a notary public

Procedure

Procedure type

Permit Difficulty High
A procedure that allows a business, activity or stay that the law generally restricts, after review; licenses fall into this type. The authority reviews facility standards, location and consultation with other agencies, and a permit can be refused if the standards are not met.
Notification Difficulty Low
You submit the statutory report form and required documents. Once the documents are in order the report is accepted; for some reports the authority checks the contents before accepting it.

We prepare import licenses for veterinary medical devices and product approval/report documents. We compare the provided technical data with the country of manufacture certificate and guide you through the necessary document authentication procedures and coordination with a notary public.

Scope & fee

Import business permit or notification: 1 product subject to notification: We will prepare an import business license for 1 company and reporting documents for 1 item of animal medical device to be reported. Facilities, quality manager, and completed technical data are provided, but testing, technology development, product approval review, and on-site visits are separate.; Official fee source ↗
Veterinary medical device import business permit only: We will prepare the import license documents for veterinary medical devices for 1 company. Proof of facility, quality manager, etc. is provided, but reporting, certification, permission, GMP, testing, and on-site visit for each item are not included.; Official fee source ↗
For a licensed importer: 1 veterinary medical device product subject to notification only: We will prepare a declaration form for 1 item of animal medical device subject to reporting from 1 licensed importer. Completed technical data is provided, and business license, approval review items, testing, and GMP are separate.; Official fee source ↗
For a licensed importer: administrative documents for product approval of 1 veterinary medical device: We will prepare administrative documents for 1 item of veterinary medical device subject to approval from 1 licensed importer. Completed technology, testing, and quality data are provided, but new technical document development, testing, clinical trials, overseas document acquisition, and on-site visits are separate.; Official fee source ↗

Authentication of Documents for Export and Overseas Submission (Apostille and Consular Confirmation) →

01
Check animal use and grade: Confirm the product is used only on animals for diagnosis, treatment, injury correction, examination or replacement of structure or function, or pregnancy control, then find its grade (1 to 4) in the product classification notified by the QIA head. If it is also used on humans it falls under the Ministry of Food and Drug Safety, so clarify the intended use first.
02
Decide the approval or report route: Grade 2, 3 and 4 products, and Grade 1 products not substantially equivalent to an already approved or reported product, need import approval; substantially equivalent Grade 1 products are handled by import report. The route decides whether Annex Form No. 5-2 or No. 5-4 and which attachments apply.
03
Prepare the import business license documents: Assemble the Annex Form No. 13-2 application, the facility and equipment specification needed for import and quality control, and two physician certificates for an individual representative (issued within 6 months), and attach an import approval application or import report for at least one product. For corporations, the official handling the file checks the corporate registry through shared government data.
04
Cross-check product and manufacturing-country documents: Check that product name, model, grade, materials, intended use, directions for use and test standards match across the application, technical document, test report, manufacturing certificate and sales certificate. Confirm both certificates were issued within 2 years of the application date, and obtain notarized originals from the manufacturing country in advance where they are required.
05
Submit to the QIA and respond to supplement requests: Once you submit the application and attachments, the QIA reviews the documents and technical document. Processing takes 10 days for the import business license and import report, and 10 to 80 days for import approval depending on the scope of review. If a supplement is requested, submit the additional material within the deadline.
06
Receive the license and prepare for customs clearance: If the QIA head finds the application in order, an import business license is issued. When importing, you must comply with the import and export guidelines for veterinary drugs, etc. and file a standard customs clearance pre-report by electronic trade document with the documents the QIA head specifies, so confirm the required documents before shipment.

Filing route

Animal and Plant Quarantine Agency (QIA head; electronic or written submission)

Confirm the current filing office, jurisdiction, and online availability on the official website.

Official check

Actual processing agencyCompetent Korean authority or official service

Statutory and policy authorityMinistry of Agriculture, Food and Rural Affairs

Online routeOfficial check

Deadlines & processing notes

Check deadlines and next steps against the notice, filing date, and any request for additional documents.Official check

Fees & official charges

Administrative service fee

Import business permit or notification: 1 product subject to notification from KRW 500,000
Veterinary medical device import business permit only from KRW 400,000
For a licensed importer: 1 veterinary medical device product subject to notification only from KRW 400,000
For a licensed importer: administrative documents for product approval of 1 veterinary medical device from KRW 500,000

All administrative service fees exclude 10% VAT.

Government fee / taxDepends on the filing type and competent authorityOfficial fee source

Included in the basic fee — Initial document review, required-document guidance, basic form preparation, one filing support and responses to up to two supplement requests.

Conditional success fee — For this service, any conditional success fee may be separately agreed within the lawful service scope and stated in a written engagement agreement. No outcome is guaranteed.

Displayed amounts are starting estimates, not statutory or standard rates. The final fee is confirmed after consultation and document review in the engagement agreement. Government fees and actual expenses may change.

Fees & official charges →

Basic documents

Basic documents0 / 8

Veterinary medical device import business license application (Annex Form No. 13-2 of the Rules on Handling Veterinary Drugs, Etc.)Veterinary medical device import approval application (Annex Form No. 5-2) or import report (Annex Form No. 5-4, for substantially equivalent Grade 1 products)Facility and equipment specification needed for import and quality controlTwo physician certificates of the representative (not mentally ill or a drug addict; issued within 6 months; not required for corporations)Product information (name, model, grade, shape, structure, materials, performance, intended use, directions for use, storage method, shelf life, precautions, test standards)Technical document, safety and efficacy review materials, and test report from a designated testing institution (approval products)Manufacturing certificate from the producing country's government and sales certificate from the licensing or registration country's government (issued within 2 years of application; including notarized manufacturing-country originals where required)Power of attorney (for submission by an agent)

(동물용의료기기, 동물용체외진단의료기기)수입업 허가 신청서(별지 제13호의2서식)

HWP original PDF

Source: Korea National Law Information Center, 「동물용 의약품등 취급규칙」 별지 제13호의2서식(effective 2025.10.31.) · checked 2026.10.26. · the form is in Korean; confirm it is the current version before submitting.

If a manufacturing or sales certificate was issued more than 2 years before the application date, or the product name or model differs from the technical document, a supplement request delays processing and notarized documents may have to be obtained again from the manufacturing country.

Scope of services

Hwang Yunsang Administrative Agent Office prepares and translates documents for administrative agencies, submits them on your behalf, and guides you through permit, application, and notification procedures. Services that require the principal’s personal appearance, principal’s application, or electronic signature may be limited in delegation.