Informatiom on PPE (Personal Protective Equipment)
- Registration Date 2020-05-29
- Hit 1800
The Ministry of Food and Drug Safety (MFDS) regulates certain products related to COVID-19 response such as test kits, filtering respirators and surgical masks classified as quasi-drugs, hand sanitizers, thermometers, ventilators, disposable syringes, among others.
o The MFDS is constantly sharing the updated information related to test kits, including the list of test kits approved for export and their manufacturers, with the North American and European Economic Affairs Division at the Ministry of Foreign Affairs(MOFA). Please contact the MOFA for further assistance with access to the information.
o The exportation of filtering respirators and surgical masks designated as “quasi-drug” by the MFDS is legally prohibited from Feb. 26, 2020 until Jun. 30, 2020. Such masks include:
* Applicable Provision: Article 5 of MFDS Notification No. 2020-14 “Emergency Adjustment Measures for Supply and Demand of Face Masks and Hand Sanitizers,” in effect as of Mar. 6, 2020
1) “Filtering Respirators” which means products used to protect the respiratory system against an infectious agent or toxic substances such as yellow dust and fine dust; and
2) “Surgical Masks” which means products used to prevent infection during medical care, treatment, or surgery.
o The exportation of medical devices, such as thermometers and ventilators, is not legally prohibited. However, the MFDS is currently monitoring the supply and demand of medical devices as the total number of confirmed COVID-19 cases in Korea.
o Information on authorized medical devices or manufacturers in Korea is available on the MFDS’ website (https://emed.mfds.go.kr) under e-Government Service Portal for Medical Devices > Information>Product Information > Manufacturer/Product Information
For your information, masks that fall under the category of industrial products, such as cloth masks, masks for thermal insulation, fashion masks, protective clothing, safety goggles, are not regulated by the MFDS. Please direct all inquiries related to such items to the Ministry of Trade, Industry and Energy or other responsible departments.
o The MFDS is constantly sharing the updated information related to test kits, including the list of test kits approved for export and their manufacturers, with the North American and European Economic Affairs Division at the Ministry of Foreign Affairs(MOFA). Please contact the MOFA for further assistance with access to the information.
o The exportation of filtering respirators and surgical masks designated as “quasi-drug” by the MFDS is legally prohibited from Feb. 26, 2020 until Jun. 30, 2020. Such masks include:
* Applicable Provision: Article 5 of MFDS Notification No. 2020-14 “Emergency Adjustment Measures for Supply and Demand of Face Masks and Hand Sanitizers,” in effect as of Mar. 6, 2020
1) “Filtering Respirators” which means products used to protect the respiratory system against an infectious agent or toxic substances such as yellow dust and fine dust; and
2) “Surgical Masks” which means products used to prevent infection during medical care, treatment, or surgery.
o The exportation of medical devices, such as thermometers and ventilators, is not legally prohibited. However, the MFDS is currently monitoring the supply and demand of medical devices as the total number of confirmed COVID-19 cases in Korea.
o Information on authorized medical devices or manufacturers in Korea is available on the MFDS’ website (https://emed.mfds.go.kr) under e-Government Service Portal for Medical Devices > Information>Product Information > Manufacturer/Product Information
For your information, masks that fall under the category of industrial products, such as cloth masks, masks for thermal insulation, fashion masks, protective clothing, safety goggles, are not regulated by the MFDS. Please direct all inquiries related to such items to the Ministry of Trade, Industry and Energy or other responsible departments.
Attached File
Division 국제협력담당관
Written by 배성명
Telephone 043-719-1559