Medical masks belong to the second category of medical devices. The food and drug regulatory authorities of all provinces, autonomous regions, and municipalities directly under the Central Government should, in accordance with the requirements of the "Notice on Strengthening the Supervision of Medical Masks" (Food and Drug Administration [2009] No. 95), strengthen the supervision of the standards for approved medical masks within their jurisdictions , strictly require relevant enterprises to organize production and standardize instructions for use and packaging labels in accordance with national standards, industry standards or registered product standards, and guide medical institutions and the public to choose appropriate masks according to the purpose of use.
Various medical masks that contain sterilizing, bacteriostatic and antiviral ingredients and are expected to be used for antibacterial and antiviral purposes are managed as Class III medical devices. At present, the national bureau has not approved such products. Relevant manufacturing enterprises should apply for registration with the National Bureau of Medical Devices in accordance with relevant regulations, and can only produce and sell medical devices after obtaining approval and obtaining a medical device registration certificate.