Understanding Quasi-Drugs and Medical Products

It can be difficult to understand the rules and restrictions associated with every product. Please see below for resources on quasi-drug products, what they are, and what restrictions may apply to selling them in South Korea.

“Quasi-drug” refers to products, among others, fibers, rubber products, and other similar products used to treat, alleviate, or prevent human or animal disease. “Medical device” refers to an instrument, machine, apparatus, material, software, or any other similar product used alone or in combination with human beings or animals. The sale of quasi-drugs and medical products is subject to certain restrictions if the quasi-drugs or medical products do not obtain product approval in Korea. Such product approval, which is similar to the KC verification process, comes hand in hand with certain business license requirements. Pursuant to the Medical Devices Act in Korea, Korean manufacturers and Korean importers must file for permission, certification, or notification for manufacturing/import by item category beforehand and obtain permission, certification, or notification for each item from the Minister of Food and Drug Safety in Korea.

Because of this, we do not recommend selling quasi-drugs or other medical devices. Products without proper approval, etc., are prohibited from sale.

Quasi-drugs and medical products include:

• Sunscreen
• Sanitary pads, tampons, or menstrual cups
• Masks for general health purposes
• Bandages, gauze, band-aids, or eye-patches
• Contact lenses
• Mouthwash
• Kinds of toothpaste
• Dentures
• Anti-odor agents
• Heat rash solvents
• Repellants
• Thermometers
• Covid19 diagnosis kit
• Blood pressure monitor
• Pregnancy/ovulation test
• Products used for the purposes of reducing the desire to smoke
• Products inhaled in a form similar to tobacco
• Disinfectants and ointments for external use/ for direct use on the human body
• Anti-snoring products
• Etc.

For more information on quasi-drug products, please navigate to: National Legal Information Center | Delegated Administrative Rules (law.go.kr).

Information on medical products can be found here:Medical Device Safety Bookstore Medical Device Comprehensive Information Platform (mfds.go.kr).

Please use a machine translation plug-in or extension for the best experience on both of these pages. Several browsers (such as Google Chrome and Microsoft Edge) have automatic machine translations available as well.

For more information on our Rules and Policies, please navigate to: Rules and policies – Coupang Marketplace.