Cosmetics & Quasi-Drug Manufacturing/Import License
Manufacturing or importing cosmetics and quasi-drugs (의약외품) in Korea requires registration or licensing with the Ministry of Food and Drug Safety. This is essential for beauty brands, OEM manufacturers, and importers operating in the Korean market.
How We Handle It
License Type Determination
Assessment of product category and required license type
Facility / RP Setup
GMP facility preparation or Responsible Person appointment
Filing
Submission to Ministry of Food and Drug Safety
Completion
Registration/license issuance
Frequently Asked Questions
Q. What is a quasi-drug?
A. Quasi-drugs (의약외품) are products between cosmetics and pharmaceuticals — such as disinfectants, whitening toothpaste, and hair dye. They require separate licensing.
Q. Is a manufacturing facility required for cosmetics?
A. For manufacturing, a GMP-compliant facility is required. For import, a Responsible Person (RP) must be appointed.
Q. How long does cosmetics manufacturing registration take?
A. Approximately 4–8 weeks after all documents and facility inspections are complete.
Q. Can foreign cosmetics be imported without a Korean company?
A. No. A Korean responsible person (company or individual) must be designated to import cosmetics into Korea.