The qualification requirements related to the production of different types of masks are different, depending on the type of mask you produce.
It is understood that medical device products are mainly divided into Ⅰ, Ⅱ, Ⅲ, this classification is mainly based on the safety of the medical device itself, so as to ensure the safety and effectiveness of medical devices.
For example, medical masks, in general will be divided into a class of products, and in the SARS period and other time of infection rate is very high, it will be divided into the second class, this is to ensure that medical masks have a clear isolation role, rather than simply ordinary masks.
According to the "Notice on Strengthening the Supervision of Medical Masks" (Food and Drug Administration Office of Equipment [2009] No. 95), to strengthen the supervision of the approved medical masks under the jurisdiction of the adoption of standards,
Strictly require the relevant enterprises to organize the production of and standardize the instructions for use and packaging labels in accordance with the national standards, industry standards or standards for registered products, and to guide the medical institutions and the public according to the The use of the purpose of selecting the appropriate mask, so this time the medical mask belongs to the second category of devices.
In addition, with a variety of ingredients containing sterilization, bacteriostatic and antiviral, expected to be used for antibacterial and antiviral medical masks according to the management of Class III medical devices, want to produce Class III medical masks of the relevant enterprises must be in accordance with the relevant provisions of the National Bureau of the National Bureau of the application for registration, only after the approval of the certificate of registration of medical devices can be produced and sold.