Original title: Medical masks and protective suit belong to several categories of medical equipment? 2020 is destined to be a year for us to learn to cherish. Since the new coronavirus began to rage, domestic masks and protective suit have suddenly been out of stock. At present, most pharmacies and supermarkets in China can not buy masks and protective suit. Only a few cities are rationed by the government. What are medical masks and protective suit, and what kind of medical equipment do they belong to? Medical device products are mainly divided into Class I,Medical Full Body Coverall, II and 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. Class I products only ensure the specifications of the products,KN95 Mask with Fast Shipping, and the relative requirements will not be too strict. Class II products are controlled by the Food and Drug Administration for their safety and effectiveness, with higher requirements. Medical masks and protective suit belong to several categories of medical equipment? Class III products refer to products that need to be implanted into the human body to support and maintain life. Because of the potential danger of such products, the approval of the Food and Drug Administration will be more stringent. Only approved medical device products can have registration certificates. But generally speaking, Medical Quickly Delivery Antivirus Coverall ,KN95 Mask for Epidemic Prevention and Control, the approval classification of a certain type of medical devices is not very strict, such as medical masks, which are usually classified into one category of products, but in the period of Severe Acute Respiratory Syndrome (SARS) and other periods of high infection rate, they will be classified into two categories, in order to ensure that medical masks have a clear isolation effect, rather than simply ordinary masks. In accordance with the requirements of the Notice on Strengthening the Supervision of Medical Masks (Food and Drug Administration No.95, 2009), the supervision of the adoption of standards for approved medical masks within the jurisdiction shall be strengthened, and relevant enterprises shall be strictly required to organize production in accordance with national standards, industry standards or registered product standards and standardize the use instructions and packaging labels. To guide medical institutions and the public to choose appropriate masks according to the purpose of use, so the medical masks and protective suit at this time belong to the second category of devices. In addition, medical masks and protective suit that contain various sterilization,KN95 Face Mask, bacteriostasis and antiviral ingredients and are expected to be used for antibacterial and antiviral purposes are 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 registration certificate of medical devices can they produce and sell them. Zhonglong Group is a business agency company, which can provide you with services such as company registration and second-class filing of medical devices in a short time. It has been operating in good faith for more than ten years and is your trustworthy business partner. Return to Sohu to see more Responsible Editor:. zjyuan-group.com
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