Quasi-Drug vs Cosmetics in Korea — Legal Definitions, Product Examples and Licensing Routes

The difference between a quasi-drug and a cosmetic in Korea lies in the governing law and the business procedure. A quasi-drug (의약외품) is an article designated by the Minister of Food and Drug Safety under the Pharmaceutical Affairs Act, while a cosmetic is an article that meets the definition in the Cosmetics Act. The classification decides whether you file a manufacturing business report and obtain a product permit, or register as a cosmetics manufacturer or responsible distributor.

The legal definitions differ

The Cosmetics Act defines a cosmetic as an article applied to the body by rubbing, spreading, spraying or similar methods to cleanse or beautify the body, add attractiveness, brighten the appearance, or maintain or improve the health of skin and hair, with only a mild effect on the human body. Articles that are medicines under the Pharmaceutical Affairs Act are excluded.

The Pharmaceutical Affairs Act defines a quasi-drug as an article in one of the three groups below that the Minister of Food and Drug Safety designates. Articles used to diagnose or treat disease, or to produce a pharmacological effect, are medicines rather than quasi-drugs.

• Textile or rubber products, or similar items, used to treat, relieve, manage or prevent disease
• Items with a weak effect on the body or no direct effect on it, which are not instruments or machines, and similar items
• Preparations used for sterilisation, insecticide or similar purposes to prevent infectious diseases

Functional cosmetics are not governed by a separate law; they are a type of cosmetic that helps with effects set out in the Act, such as whitening, wrinkle improvement or UV protection, as specified by Ordinance of the Prime Minister.

Which products fall where

Specific quasi-drug items are listed in the MFDS public notice on the designation of the scope of quasi-drugs, and the scope of functional cosmetics is set by the Enforcement Rule of the Cosmetics Act.

Category	Examples named in the rules
Quasi-drugs (textile and rubber products, etc.)	Sanitary pads, tampons and menstrual cups; surgical, health and droplet-blocking masks; eye patches, bandages, gauze, cotton wool and adhesive plasters
Quasi-drugs (mild preparations, etc.)	Toothpaste, mouth fresheners, antiperspirants for body odour, prickly heat remedies, mosquito and tick repellents, contact lens care products, external disinfectants for human use, tooth whiteners, smoking cessation aids without nicotine
Quasi-drugs (similar items)	Oral cleansing wet wipes, sterile swabs and gloves, portable oxygen inhalers
Functional cosmetics	Whitening, wrinkle improvement, UV protection and tanning, hair dyeing and bleaching, hair removal, relief of hair-loss symptoms, acne-prone skin care (cleansing products only), skin barrier recovery, stretch mark redness
General cosmetics	Products that fit the cosmetic definition and none of the above

Hair dyes and hair-loss products are not on the current quasi-drug list; the Enforcement Rule treats them as functional cosmetics. Products that change hair colour only temporarily, remove hair physically, or merely make hair look thicker by coating are outside the functional scope. A safe order for classifying a product is:

1. Check whether the purpose is to diagnose or treat disease or to cause a pharmacological effect. If so, review it as a medicine.
2. Check whether it appears on the quasi-drug designation list.
3. If not, check whether it claims an effect within the functional cosmetics scope.
4. If none applies, treat it as a general cosmetic and decide on business registration.

Procedures compared — report and permit vs registration and review

Once the classification is settled, even the names of the procedures change. Quasi-drugs need a manufacturing business report and a product permit or product report; cosmetics need business registration; functional cosmetics add a product-by-product review or report submission.

Item	Quasi-drugs	Cosmetics (incl. functional)
Business procedure	Manufacturing business report after meeting facility standards	Registration as a cosmetics manufacturer or responsible distributor
Filed with	Regional Office of Food and Drug Safety	Regional Office with jurisdiction over the factory or distributor's office
Product-level step	Product permit or product report for each item (report for items meeting standard manufacturing criteria, etc.)	No product permit for general cosmetics; safety and efficacy review or report for functional cosmetics
Required staff	Manufacturing manager (pharmacist or herbal pharmacist; an approved technician if only textile or rubber products are made)	Responsible sales manager for distributors; facility standards for manufacturers

When filing a quasi-drug manufacturing business report, you must apply for a permit for, or report, at least one product in that line at the same time, and changes may require a change report. Our post on the cosmetics responsible distributor registration covers the distributor route.

If you make cosmetics yourself, you need manufacturer registration; if you distribute or import them under your name, you need responsible distributor registration. Secondary packaging or labelling alone does not count as manufacturing. For functional cosmetics, a product identical in ingredients and content to a notified item can be reported to the National Institute of Food and Drug Safety Evaluation instead of reviewed; others are reviewed. See our cosmetics registration and functional cosmetics review services.

YouSun Administrative Agency (Chief Administrative Agent Jung Yu-sun)