The State Food and Drug Administration further regulates the registration of medical masks

The State Food and Drug Administration issued a notice a few days ago to make clear provisions on the standards, important technical indicators, and scope of application of medical masks. The circular emphasized that the State Food and Drug Administration has not approved sterilization, antibacterial and antiviral components, and is expected to be used for antibacterial and antiviral medical masks.

It is understood that medical masks are used as medical device management masks, including medical masks, medical surgical masks, and general medical masks. The standards, important technical indicators, and applicable scope of the masks are all strictly required. For example, medical protective masks need to meet the GB19083-2003 "medical protective mask technical requirements" standard, important technical indicators include non-oil particle filtration efficiency and airflow resistance, suitable for medical personnel and related staff to protect against airborne respiratory infections , High degree of protection. Ordinary absorbent gauze masks are not managed as medical devices.

The notification requires that the food and drug supervision and administration departments of provinces, autonomous regions, and municipalities directly under the Central Government shall, in accordance with the requirements of the Circular on Strengthening the Supervision of Medical Masks, strengthen the supervision over the standards of medical masks that have been approved within the jurisdiction and strictly require the relevant enterprises to follow national standards. Industry standards or registered product standards organize the production and specification of instruction manuals and packaging labels, and guide medical institutions and the public to select appropriate masks according to the purpose of use.

At present, the State Food and Drug Administration has not approved a variety of ingredients containing bactericidal, antibacterial and anti-viral components and is expected to be used for anti-bacterial anti-virus medical masks. The relevant manufacturer shall apply for registration with the State Food and Drug Administration in accordance with the relevant regulations, and may only produce and sell the medical device after obtaining approval for the registration of the medical device.