Registration of medical face mask

Recently, the State Food and Drug Administration (SFDA) issued notice on clarifying the standards and rational usage for medical face mask.

The notice says that medical face mask belongs to class II medical device; All the food and drug regulatory departments at provincial level should enhance administration on the standards of the medical face masks in their jurisdiction, require the companies manufacturing as standards, and give guidance to the medical institutions and the public using rational medical face masks.

The medical face mask containing antiseptic, antiblastic or antiviral components belongs to class II medical device. At present, no approval concerning such products has been given by SFDA. Any companies who want to manufacture and market the products must obtain the registration certificate for medical device from SFDA.