Quasi-drug Products Registration in South Korea

Cosmetics in Korea are mainly regulated by the Cosmetic Act, Enforcement decree and Enforcement Rule of the Cosmetics Act.

Quasi-drugs are not included in the definition of cosmetics, as designed by article 2, clause 4, of the Pharmaceutical Affairs Act. It means any of the following articles designated by the Minister of Food and Drug Safety (excluding articles which shall be used for the purposes prescribed in subparagraph 4 (b) or (c)):

(a) Fibers, rubber products, or similar products used for the purpose of treatment, alleviation, care, or prevention of human or animal diseases;

- ex) Sanitary pads, tampons, bandages, KF94/90/80 masks, KF-AD mask etc.

(b) Non-appliance, non-machinery, or similar articles that have insignificant influences on or do not directly act upon human bodies;

- ex) Oral fresheners, deodorants, toothpastes, contact lens solutions, bandages, hand sanitizers etc.

(c) Medication for sterilization, insecticide, and other similar uses for the purpose of preventing infectious diseases;

- ex) Disinfectants which are NOT applied direct to the human body etc.

Any person who files an application for approval or notification of a quasi-drug product for the first time shall register as a quasi-drug manufacturer or import business to the commissioner of the competent Regional Office of Food and Drug Safety (RFDS).

Who Shall Register

• Domestic or overseas cosmetic manufacturers/distributors who export cosmetics to KR

• Importer of cosmetics in KR

Our Services

CIRS China can act as a technical provider for foreign and domestic cosmetic manufacturers or distributors who want to export cosmetics to KR to notify quasi-drugs so as to comply with the Pharmaceutical Affairs Act.

Our services include:

KR Quasi-drugs Notification	Formula and label review Being Market Authorization Holder Registration for melt-blow polypropylene mask Preparation of technical document for manufacturer Application of test and inspection for finished product according to Korean standards