How to File a Medical Device Sales Business Report and Obtain an Import Business Permit — Public Health Center Report vs. Ministry of Food and Drug Safety Permit

Procedure

1. 1. Distinguish sales or leasing from import or manufacturing

   Buying medical devices distributed in Korea and selling or leasing them is subject to a report to the city, county or district (si/gun/gu) office. Bringing in overseas products or manufacturing devices yourself is subject to a permit from the Ministry of Food and Drug Safety, and when applying for the business permit you proceed with a permit, certification or report for 1 or more products at the same time.

2. 2. Check whether you are exempt from the report

   A sales business report is not required when a manufacturer or importer sells medical devices it has manufactured or imported to medical device handlers, or when a pharmacy operator or a drug wholesaler sells medical devices. You are also exempt from the report when you sell only products specified in the Enforcement Rule, such as condoms and blood glucose meters combined with mobile phones or home appliances.

3. 3. Prepare the place of business

   The report is filed for each place of business. If you sell only by e-commerce or mail-order sales, a building for residential use or a business incubation center can be used as the place of business. If you keep a separate warehouse, also set out the storage location and the management method.

4. 4. Submit the report form and receive the report certificate

   Submit the sales business (leasing business) report form to the city, county or district (si/gun/gu) office having jurisdiction over the place of business. The department in charge must give notice of whether the report is accepted within 3 days, and if no notice is given within that period, the report is deemed accepted on the day after the period ends. Once it is accepted, a report certificate is issued, and if the trade name, location or other details change, file a report of change.

5. 5. Check the rules to follow while in business

   A medical device seller must comply with the medical device distribution quality control standards. Medical devices purchased from a medical institution can be sold only if they have been inspected and have received an inspection certificate, and the inspection records are kept for 2 years from the date of sale. Providing economic benefits to medical personnel to promote sales is also prohibited.

Required documents

• Medical device sales business (leasing business) report form
• Identification of the representative (for a corporation, the corporate register certificate is checked through administrative information)
• Materials showing the right to use the place of business (copy of the lease contract, etc.)
• Copy of the business registration certificate (if issued)
• For an import or manufacturing business permit: permit application, materials for the product permit, certification or report, and materials on the facilities and the quality management system
• Letter of authorization (when filed by an agent)

Fees

Fees in the industry are around several hundred thousand won. The scope of preparation differs greatly between a sales business report and an import or manufacturing business permit, so we will advise you of the fee after reviewing the matter in a consultation. Government fees are separate.

See fees and official charges for this service →

Legal basis and review date

• Medical Devices Act, Article 6
• Medical Devices Act, Article 15
• Medical Devices Act, Article 17
• Medical Devices Act, Article 18
• Enforcement Rule of the Medical Devices Act, Article 37
• Enforcement Rule of the Medical Devices Act, Article 38
• Enforcement Rule of the Medical Devices Act, Article 39

Checked against the statutes on 2026-10-04

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 you move the place of business and the competent city, county or district (si/gun/gu) office changes, file a report of change with the authority having jurisdiction over the new location.
• Selling medical devices without a report may be subject to punishment, so obtain the report certificate before you start selling.

Frequently asked questions