Medical Device Sales Business Report and Import Business Permit

Procedure

01
Classify the business: Buying and selling or leasing medical devices already distributed in Korea requires a sales (leasing) business report to the city, county or district. Importing foreign products requires an import business permit from the Regional Office of Food and Drug Safety, and manufacturing requires a manufacturing business permit, so settle the business structure first.
02
Check for exemptions: No sales business report is needed when a manufacturer or importer sells its own products to medical device handlers such as medical institutions or sellers, for pharmacy operators and pharmaceutical wholesalers, or when selling only condoms or blood glucose meters combined with mobile phones or home appliances.
03
Prepare the place of business and storage: A report is filed for each place of business, and if you sell only through e-commerce or mail order, a residential building or a startup incubation center may be used as the place of business. If you keep a storage area, meet the Good Supply Practice facility standards, such as keeping products off the floor, maintaining temperature and humidity, and installing pest control and fire-fighting equipment.
04
File the report and receive the certificate: Submit the sales (leasing) business report through Government24 or to the competent public health center, and you will be notified within 3 days whether it is accepted. Once accepted, a report certificate is issued, and for corporations the authority checks the corporate register through shared administrative information.
05
Apply for an import business permit (if importing): Attach the representative's medical certificate (not required for corporations) and the quality manager's qualification and employment documents to the application and file it with the Regional Office of Food and Drug Safety with jurisdiction over the import business office. Product import approval goes to the Ministry of Food and Drug Safety, and import certification or notification goes to the National Institute of Medical Device Safety Information, in parallel.
06
Operational compliance and change reports: Appoint a person in charge, keep the facilities and equipment ledger, shipment ledger and complaint handling ledger for 2 years, and provide in-house training at least once per quarter for a total of 12 hours per year. File a change report when reported particulars change, and for a relocation that changes jurisdiction, file with the city, county or district of the new location.

Filing route

Sales and leasing business reports: city, county or district (public health center) where the place of business is located; import business permit: Regional Office of Food and Drug Safety with jurisdiction over the import business office

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

Official check

Actual processing agencyCompetent Korean authority or official service · Competent Korean authority or official service

Statutory and policy authorityMinistry of Food and Drug Safety

Online routeGovernment24

Deadlines & processing notes

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

Basic documents

Basic documents0 / 8

Medical device sales (leasing) business report (Form No. 36 of the Enforcement Rule of the Medical Devices Act)Representative's ID (for corporations, the corporate register is checked through shared administrative information)Proof of right to use the place of business (copy of lease agreement, etc.)Documents showing the location and floor area of the place of business and storage (if requested by the public health center)Copy of business registration certificate (if issued)Medical device import business permit application (Form No. 1 of the same Rule) and the representative's medical certificate (issued within 6 months, not required for corporations)Quality manager qualification documents and proof of employment such as a certificate of employment (import business)Product import approval application (Form No. 3), import certification application (Form No. 5) or import notification (Form No. 7), with documents proving the manufacturing site's quality management system

An importer is exempt from the sales business report only when selling its imported products to medical device handlers, so a separate sales business report must be completed before selling directly to consumers or listing products on an online store.

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.