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22-1 · Veterinary medicines & devices

Veterinary Medical Device Import Business License and Product Approval (Technical Documents and Notarized Manufacturing-Country Documents)

Medical devices used only for animals fall under the Ministry of Agriculture, Food and Rural Affairs under Article 46 of the Medical Devices Act, and under Article 2-2(2) of the Rules on Handling Veterinary Drugs, Etc., the Animal and Plant Quarantine Agency (QIA) handles their manufacture, import and sale. To import, under Article 19-2 of the same Rules you submit the import business license application (Annex Form No. 13-2) with the facility and equipment specification and an import approval application or import report for at least one product to the QIA head. Each product needs either import approval or an import report depending on its grade, and approval products require the technical document, a test report, a manufacturing certificate from the government of the producing country and a sales certificate from the government of the country where it is licensed or registered, both issued within 2 years of the application date. An individual representative must also submit physician certificates that he or she is not mentally ill or a drug addict, issued within 6 months; corporations are exempt.

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#Veterinary Medical Device Import Business License and Product Approval (Technical Documents and Notarized Manufacturing-Country Documents)#Official check#22-1
🌐 Veterinary Medical Device Import Business License and Import Approval
01

Procedure

Procedure

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

02

Filing route

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
03

Deadlines & processing notes

Deadlines & processing notes

Check deadlines and next steps against the notice, filing date, and any request for additional documents.Official check
04

Basic documents

Basic documents

Basic documents0 / 8

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

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.