The qualifications required to produce different types of masks are also different, depending on the type of masks you produce.

It is understood that medical device products are mainly divided into Class I, Class II, and Class III. This classification is mainly based on the safety of the medical device itself, so as to ensure the safety and effectiveness of the medical device.

For example, medical masks are generally classified as Class I products, and in periods of extremely high infection rates such as the SARS period, they are classified as Class II. This is to ensure that medical masks have a clear isolation effect, rather than being simple ordinary masks.

According to the requirements of the "Notice on Strengthening the Supervision of Medical Masks" (Food and Drug Administration Office of Equipment [2009] No. 95), strengthen the supervision of the use of standards for approved medical masks in the jurisdiction,

Strictly require relevant enterprises to organize production in accordance with national standards, industry standards or registered product standards and standardize the instructions for use and packaging labels, and guide medical institutions and the public to choose appropriate masks according to the purpose of use. Therefore, medical masks at this time belong to Class II devices.

In addition, medical masks with various sterilizing, antibacterial and antiviral ingredients that are intended to be used for antibacterial and antiviral purposes are managed as Class III medical devices. Relevant companies that want to produce Class III medical masks must apply for registration with the National Bureau in accordance with relevant regulations. Only after obtaining a medical device registration certificate can they be produced and sold.