Medical masks belong to the second class of medical devices. Provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration should be in accordance with the "on strengthening the supervision of medical masks notice" (Food and Drug Administration Office of the equipment [2009] No. 95) requirements, to strengthen the jurisdiction of the approved medical masks to adopt the standard of supervision, and strictly require the relevant enterprises in accordance with national standards, industry standards or registered product standards to organize the production and standardization of instruction manuals and packaging and labeling, guidance to medical institutions and the public to choose the appropriate mask according to the purpose of use. Medical institutions and the public to choose the appropriate masks according to the purpose of use.
A variety of medical masks containing sterilizing, antibacterial and antiviral ingredients, which 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. The relevant manufacturers should apply for registration with the National Bureau in accordance with the relevant provisions, and can only produce and sell them after approval of the certificate of registration of medical devices.