Is the medical N95 mask with safety control normal?

At the moment when the epidemic broke out, panic filled the whole country. Academician Zhong Nanshan said, "Wear a mask if you feel uncomfortable. Wearing a mask is still useful. " . In the case that major pharmacies are 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 "if you want to wear a multi-layer mask, you must wear N95 medical mask!"

A few days ago, People's Daily has issued a document refuting this rumor, and Academician Zhong Nanshan also clarified that it is not necessary to wear N95 medical masks, and ordinary masks can prevent most droplets with viruses from entering the respiratory tract.

What makes people angry is that some people are still creating a "national disaster", and many regions have successively announced the news of seizing fake masks and arresting fake gangs; The circle of friends is still full of various purchasing advertisements: "Did you buy a genuine N95 medical mask? There is only 100 here! " Neighbors in the same community as Dafang couldn't help saying in a circle of friends: "I recently brought back 654.38+ million N95 medical masks from Dubai, but I didn't approve the number. You can call me if you need it! "

So, what is the N95 medical mask? What are the risks of selling or using N95 medical masks purchased overseas? Generous answer for you one by one:

1.N95 medical protective mask belongs to the national second-class medical devices, and its import is strictly regulated by the state.

According to Zheng, vice president of China Health Law Society, masks in China are currently divided into three categories: daily protective masks, labor protective masks (special labor protection products) that need LA certification, and masks used for medical device management (such as medical protective masks, disposable general medical masks, and medical surgical masks).

Among them, N95 medical mask is one of nine kinds of particle protection masks certified by NIOSH (National Institute of Occupational Safety and Health).

As early as during the SARS in 2003, the former US Food and Drug Administration issued the Notice on the Classification of Medical Disposable Protective Clothing and Other Products, which stipulated that medical disposable protective clothing, medical protective masks and medical surgical masks should be classified as the second class of medical devices for management from May 15, 2003.

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), which are included in the strict management of medical devices. Of course, the latest Catalogue of Medical Devices also lists medical protective masks as second-class medical devices.

According to the Regulation on the Supervision and Administration of Medical Devices (revised 20 17), the risk of Class II medical devices is moderate and needs to be strictly controlled and managed. According to the regulations, overseas enterprises should obtain the approval and registration of National Medical Products Administration for exporting Class II medical devices to China, and the products should have corresponding inspection reports, with Chinese instructions and Chinese labels attached after passing the inspection by medical device inspection institutions. Therefore, the import of N95 medical masks is strictly regulated by the state.

Secondly, under the epidemic situation, the State Administration of Medical Products has opened a green emergency channel: emergency import of medical devices that are not registered in China.

Recently, in order to urgently import medical devices that are not registered in China and ensure the supply of medical devices that are urgently needed for epidemic prevention, the Medical Devices Supervision and Administration Department of the State Administration of Pharmaceutical Products issued the Opinions on Urgent Import of Medical Devices that are not registered in China, that is, medical devices that meet the relevant standards of the United States, the European Union and Japan are urgently imported from abroad, and enterprises can provide overseas medical devices listing documents and inspection reports, and make a commitment to product quality and safety, which can be used in an emergency.

Jiangsu US Food and Drug Administration also began to export medical protective clothing and medical masks for emergency use in domestic epidemic prevention and control. Enterprises engaged in the export of medical protective clothing and medical masks in the province can contact Jiangsu Medical Device Inspection Institute and submit filing materials. Jiangsu US Food and Drug Administration will make clear whether the products meet the filing conditions according to the inspection and on-site inspection.

Third, the source of the purchased masks is unknown, and many of them are fake and shoddy products. If you use a mask with germs, there is a safety hazard.

The source of the purchased mask is unknown, which has great security risks. It may be that the "three no products" imported from abroad are actually fake famous brands from a domestic factory. For example, the American "3M mask" with counterfeit trademarks often uses inferior filtering materials, and the filtering performance is not up to standard; It may also be a recycled mask, which has obvious stains and is used for the second time; It may even be inferior masks produced by the "black heart" factory.

Judging from the cases of fake masks seized by the government, most of the fake mask production workshops do not have any disinfection and sterilization equipment, which is not in line with the environment for producing masks, and some are only hand-packaged masks by employees. It is worth noting that many fake masks have flowed into the purchasing circle! If consumers wear such masks, it will not only fail to protect them, but also cause greater health risks.

Here, I would like to remind you generously: if the purchasing mask is indeed purchased from overseas, there are often no corresponding Chinese labels and Chinese instructions, and it is a medical device that cannot be imported. It is difficult for ordinary people to identify its real source, so it is not recommended!

If the purchased mask is a regular medical surgical mask, it has passed the registration of the relevant state departments, and the product registration number will be on the outer packaging, with corresponding Chinese labels and Chinese instructions. The specific query method is: log in to the State Administration of Medical Supplies, and click the medical device query.

Four. Operating and using the unregistered or filed N95 medical protective mask may face corresponding administrative punishment and even criminal responsibility.

As mentioned above, the State Administration of Medical Products has issued a policy to open a green emergency channel for devices that have been approved by the US FDA, certified by the European medical device CE, and licensed for marketing in Japan, but have not yet completed the registration of imported medical devices by NMPA.

Individuals selling N95 masks purchased overseas may constitute the failure to record the sale of Class II medical devices according to Article 30 of the Regulations on the Supervision and Administration of Medical Devices (revised 20 17), and they will bear the administrative responsibility of "being ordered to make corrections and being fined less than 10000 yuan".