Import Business of Medicinal Products & Quasi-drugs License (의약품 및 의약외품 수입업)
In South Korea, the import of drugs is strictly regulated. Importers must hold an Import Business of Medicinal Products & Quasi-drugs license (의약품 및 의약외품 수입업) to operate legally. Below is a concise overview of what it covers and who needs it.
Pharmaceuticals vs. quasi-drugs
Medicinal products are items listed in the Korean Pharmacopoeia or otherwise intended to diagnose, treat, or prevent disease in humans or animals, or to pharmacologically affect structure or function; instruments, machines, and devices are excluded.
Quasi-drugs have milder or indirect effects (e.g., certain hygiene/sterilization preparations, disease-prevention goods) and are regulated separately from medical devices.
Who needs this license?
Any business importing medicinal products or quasi-drugs must submit an import-business notification to the Ministry of Food and Drug Safety (MFDS) and obtain item-level approval or file a declaration, as applicable.
What the license signifies
Holding this license confirms legal authorization to import medicinal products and quasi-drugs into Korea. It is not a one-time formality—material changes must be reported, ensuring ongoing MFDS oversight and compliance.
Coverage in KOBDi: The KOBDi database includes businesses registered with an Import Business of Medicinal Products & Quasi-drugs (의약품 및 의약외품 수입업) license. This information appears on each Business Profile page, and companies with this license can be found via the KOBDi Korea Industry Search.