It is understood that medical device products are mainly divided into I, II and III categories, which are mainly classified according to the safety of medical devices themselves, thus ensuring the safety and effectiveness of medical devices.
For example, medical masks are usually classified as one kind of products, but they are classified as two kinds in the period of high infection rate such as SARS, in order to ensure that medical masks have a clear isolation function, rather than simple ordinary masks.
According to the requirements of the Notice on Strengthening the Supervision of Medical Masks (Food and Drug Administration [2009] No.95), strengthen the standard supervision of approved medical masks within the jurisdiction.
Strictly require relevant enterprises to organize production and standardize instructions 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. Therefore, the medical mask at this time belongs to the second-class equipment.
In addition, medical masks containing sterilization, bacteriostasis, antivirus and other ingredients are expected to be managed as Class III medical devices. Relevant enterprises that want to produce Class III medical masks must apply to the State Administration for registration in accordance with relevant regulations, and only after obtaining the Medical Device Registration Certificate can they produce and sell them.