Veterinary Medical Device Import Business License and Import Approval — Documents and Processing Periods by Class

Procedure

1. 1. Confirm it is a veterinary medical device and its class

   An instrument, apparatus, material or software used on animals for diagnosing, treating, alleviating, handling or preventing disease, for correcting injury or disability, for examining, replacing or modifying structure or function, or for controlling pregnancy is a veterinary medical device. Products used only for animals fall under the Animal and Plant Quarantine Agency, and classes 1 to 4 are set by the duration of contact with the animal, the degree of invasiveness and whether drugs or energy are delivered. First find the item classification and class announced by the Commissioner and determine the class of your product.

2. 2. Choose the route for each item: import approval or import notification

   Class 2, 3 and 4 products, and class 1 products that are not substantially equivalent in structure, principle, performance, intended use or method of use to items already approved or notified, require import approval. Class 1 products substantially equivalent to items already approved or notified go through import notification. The application form, attachments and processing period differ by route.

3. 3. Prepare the import business license application

   Attach to the import business license application a list of facilities and equipment needed for import and quality control, and an import approval application or import notification for at least 1 item. If the representative is an individual, submit physician's certificates, issued within 6 months, showing that the person is not mentally ill (or that a specialist has found the person suitable) and is not addicted to narcotics; for a corporation, no certificates are needed and the official checks the corporate register through shared administrative information. The processing period is 10 days and the fee is 30,000 won.

4. 4. Organize item documents and the technical file

   For an item requiring import approval, submit material stating the product name (item name and model), classification number (class), shape and structure, raw materials, performance and intended use, method of use, packaging unit, storage method and expiry, precautions and test specifications, together with the technical file, safety and efficacy review data and a test report from a designated testing institution. Also attach a manufacturing certificate issued by the government of the producing country (including bodies it delegated or entrusted) and a sales certificate issued by the government of the country where the item is approved or registered, both issued within 2 years before the application date. Processing periods are 10 days for items needing no technical file review, 40 days for class 1 and 2 and 60 days for class 3 and 4 items needing technical file review, 80 days for items needing safety and efficacy review, and 10 days for an import notification.

5. 5. Prepare for customs clearance and sales after licensing

   Importers must follow the export and import guidelines for veterinary drugs and similar products and file a standard pre-customs report as an electronic trade document with the documents set by the Commissioner. Imported products may be released only after passing quality inspection, and must not be stored outside the licensed business premises (including warehouses). Shops that buy the imported products to sell or rent them must separately file a veterinary medical device sales or rental business report with the city, county or district office.

Required documents

• Application for veterinary medical device import business license (Enforcement Rule on the Handling of Veterinary Drugs, etc., Annex Form No. 13-2)
• Application for veterinary medical device import approval (same Rule, Annex Form No. 5-2) or import notification (same Rule, Annex Form No. 5-4, for substantially equivalent class 1 items)
• 2 physician's certificates for the representative (mental illness and narcotics addiction, issued within 6 months; not required for corporations)
• List of facilities and equipment needed for import and quality control
• Item description material (product name, class, shape, structure, raw materials, performance, intended use, method of use, storage method, expiry, precautions, test specifications, etc.)
• Technical file, safety and efficacy review data, and test report from a designated testing institution (items requiring import approval)
• Manufacturing certificate from the government of the producing country and sales certificate from the government of the approving or registering country (issued within 2 years before the application)
• Letter of authorization (when filed by an agent)

Fees

Typically from several hundred thousand won to a few million won in the industry · We will advise after consultation depending on whether you need only the import business license or item import approvals as well, the number and class of items, and the scope of technical file review. Government fees are separate.

See fees and official charges for this service →

Legal basis and review date

• Medical Devices Act, Article 2
• Medical Devices Act, Article 6
• Medical Devices Act, Article 15
• Medical Devices Act, Article 46
• Enforcement Rule on the Handling of Veterinary Drugs, etc., Article 2
• Enforcement Rule on the Handling of Veterinary Drugs, etc., Article 2-2
• Enforcement Rule on the Handling of Veterinary Drugs, etc., Article 5
• Enforcement Rule on the Handling of Veterinary Drugs, etc., Article 14
• Enforcement Rule on the Handling of Veterinary Drugs, etc., Article 16
• Enforcement Rule on the Handling of Veterinary Drugs, etc., Article 19
• Enforcement Rule on the Handling of Veterinary Drugs, etc., Article 19-2
• Enforcement Rule on the Handling of Veterinary Drugs, etc., Article 23
• Enforcement Rule on the Handling of Veterinary Drugs, etc., Article 56
• Enforcement Rule on the Handling of Veterinary Drugs, etc., Annex 4
• Enforcement Rule on the Handling of Veterinary Drugs, etc., Annex 8
• Enforcement Rule on the Handling of Veterinary Drugs, etc., Annex Form No. 5-2
• Enforcement Rule on the Handling of Veterinary Drugs, etc., Annex Form No. 5-4
• Enforcement Rule on the Handling of Veterinary Drugs, etc., Annex Form No. 13-2

Checked against the statutes on 2026-10-10

Statutes and public notices change, so each case needs to be checked individually. Statute titles are given in English for reference. The Korean statutes are the authoritative text.

Check these first

• If the product name, model, raw materials or intended use differ among the application, technical file, manufacturing-country certificates and labeling, a supplementation request will delay processing, so cross-check them all before submission.
• Requests regarding notarization or confirmation of certificates issued by foreign governments, and whether translations are required, can differ by item, so check the standards of the responsible division of the Animal and Plant Quarantine Agency before filing.

Frequently asked questions