At the moment of the epidemic, panic has spread throughout the country. Academician Zhong Nanshan said: "Wear a mask when you feel uncomfortable. Wearing a mask is still useful." With major pharmacies basically out of stock and "a mask is hard to find", everyone is discussing in the WeChat group: "Did you buy a mask today? Where else can I buy a mask?" There are even rumors that "you have to wear one" Multi-layer masks, or N95 medical masks must be worn!”

A few days ago, the People’s Daily issued an article to refute the rumors, and Academician Zhong Nanshan also clarified that it is not necessary to wear N95 medical masks, ordinary masks can block the Some virus-laden droplets enter the respiratory tract.

What is infuriating is that there are still people trying to make money from the "national crisis". Many regions have successively announced the seizure of fake masks and the arrest of counterfeiting gangs; WeChat Moments are still full of various purchasing advertisements. : "Have you bought genuine N95 medical masks? There are only 100 of them here!" A neighbor in the same community as Dafang also couldn't help but said in the circle of friends: "I recently brought back 100,000 N95 medical masks from Dubai. , but there is no approval number. If you need it, you can contact me!”

So, what exactly is an N95 medical mask? What are the risks of selling or using N95 medical masks purchased overseas? Dafang will answer your questions one by one:

1. N95 medical protective masks belong to the national second-class medical devices, and their imports are strictly regulated by the state

According to Zheng Xueqian, Vice President of the Chinese Society of Health Law According to the introduction, there are currently three main types of domestic masks: daily protective masks, labor protection masks (special labor protection supplies) that require "LA" (special labor protection equipment safety mark) certification, and masks used for medical device management (such as medical protective masks, Disposable ordinary medical masks, medical surgical masks).

Among them, the N95 medical mask is highly protective and is one of the nine types of particle protective masks certified by NIOSH (National Institute for Occupational Safety and Health).

As early as the SARS outbreak in 2003, the former State Food and Drug Administration had issued the "Notice on Classification Issues of Medical Disposable Protective Clothing and Other Products". From May 15, 2003, Medical disposable protective clothing, medical protective masks and medical surgical masks are classified as Class II medical devices for management.

Relevant national authorities have also promulgated a series of national mandatory standards such as "Technical Requirements for Medical Protective Masks" (GB 19083-2003) and "Technical Requirements for Medical Surgical Masks" (YY 0469-2004). Bring it into the scope of strict management of medical devices. Of course, the latest "Medical Device Classification Catalog" also lists medical protective masks as Class II medical devices.

According to the relevant provisions of the "Regulations on the Supervision and Administration of Medical Devices (2017 Revision)", Class II medical devices have moderate risks and require strict control and management. According to the regulations, overseas companies exporting Class II medical devices to my country must obtain approval and registration from the national drug regulatory department. The products must be inspected by medical device inspection agencies and have corresponding inspection reports, Chinese instructions and Chinese labels. Therefore, the import of N95 medical masks is subject to strict national supervision.

2. Under the epidemic situation, the State Food and Drug Administration has opened a green emergency channel: emergency import of medical devices not registered in China

Recently, for the emergency import of medical devices not registered in China , To ensure the supply of urgently needed medical devices for the fight against the epidemic, the Medical Device Supervision and Management Department of the State Food and Drug Administration issued the "Opinions on the Emergency Import of Medical Devices Not Registered in China", that is, the emergency import of medical devices that meet the relevant standards of the United States, the European Union and Japan from abroad. Devices can be used on an emergency basis if the company can provide overseas medical device listing certification documents and inspection reports and make product quality and safety commitments.

The Jiangsu Provincial Food and Drug Administration has also initiated the registration process for exporting medical protective clothing and medical masks for emergency use in domestic epidemic prevention and control.

Enterprises engaged in the production of medical protective clothing and medical masks for export in the province can contact the Jiangsu Provincial Medical Device Inspection Institute and submit filing materials. The Jiangsu Provincial Food and Drug Administration will clarify whether the products meet the filing conditions based on inspections, on-site inspections, etc.

3. The source of the masks purchased on behalf of others is unknown, and many of them are fake and shoddy products. There are safety risks if masks carrying germs are used

The sources of masks purchased on behalf of agents are unknown, and there are serious safety risks. They may be falsely claimed to be from abroad. Imported, but actually "three-no products" of domestic factories counterfeiting famous brands. For example, counterfeit American "3M masks" with forged trademarks often use inferior filter materials and have substandard filtration performance; they may also be recycled masks with obvious stains and secondary use; they may even be masks produced by unscrupulous factories with substandard quality.

According to official disclosures of cases of seized fake masks, most of the fake mask production workshops do not have any disinfection and sterilization equipment, let alone an environment suitable for mask production, and some employees only pack masks with bare hands. What’s worth being vigilant about is that many fake masks have flowed into purchasing agents! If consumers wear such masks, they will not only fail to provide protection, but will also cause greater health risks.

Here we would like to remind you: if the masks purchased on behalf of others are indeed purchased from overseas, in many cases they do not have corresponding Chinese labels and Chinese instructions. They are medical devices that are not allowed to be imported, and it is difficult for ordinary people to Identify its true source, its use is not recommended!

If the mask purchased on behalf of the agent is a regular medical surgical mask and has been registered by the relevant national departments, the product registration number will be on the outer packaging, and it will be accompanied by the corresponding Chinese label and Chinese instructions. The specific query method is: log in to the State Food and Drug Administration and click on Medical Device Query.

4. Operating or using unregistered or unfiled N95 medical protective masks may face corresponding administrative penalties and even criminal liability

As mentioned above, the State Food and Drug Administration Policies have been introduced to open a green emergency channel for devices that have obtained US FDA approval, EU medical device CE certification, and Japanese medical device marketing authorization, but have not completed NMPA imported medical device registration.

If an individual sells N95 masks purchased overseas, according to Article 30 of the "Regulations on the Supervision and Administration of Medical Devices (2017 Revision)", it may constitute the sale of Class II medical devices without registration and will be borne The administrative responsibility of "ordering corrections and imposing a fine of less than 10,000 yuan".