A few days ago, the People's Daily has issued an article to dispel the rumors, Zhong Nanshan academician also be clarified, does not have to wear N95 medical masks, general masks will be able to block most of the droplets with the virus into the respiratory tract.
It is outrageous that there are still people in the "national tragedy", many areas have been announced the seizure of fake masks, captured the news of the fake gangs; the circle of friends is also still filled with a variety of purchasing advertisements: "Did you buy the genuine N95 medical masks? There are only 100 of them here!" And generous neighbors in the same district also in the circle of friends can not help but say: "I recently took 100,000 N95 medical masks back from Dubai, but there is no approval number, you need to find me!"
So what exactly is an N95 medical mask? What are the risks of selling or using overseas purchased N95 medical masks? Generous for you to answer one by one:
One, N95 medical protective masks belong to the national class II medical devices, their imports are strictly regulated by the state
According to the Chinese Society of Health Law Vice President Zheng Xueqian introduction, the current domestic masks are mainly divided into three kinds of masks: daily protective masks, the need for "LA" (Special Labor Protective equipment safety mark) certification of labor masks (special labor protective equipment) and masks for medical device management (such as medical protective masks, disposable general medical masks, medical surgical masks).
Of these, the N95 type medical masks are more protective and are one of the nine types of particulate protection masks certified by NIOSH (National Institute for Occupational Safety and Health).
As early as 2003 during the SARS outbreak, the former State Food and Drug Administration has issued a "notice on the classification of medical disposable protective clothing and other products," the provisions of the May 15, 2003 onwards, the medical disposable protective clothing, medical protective masks and medical surgical masks are classified as Class II medical devices for management.
The relevant national authorities have also issued 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 have been incorporated into the scope of strict management of medical devices. Of course, the latest "Medical Device Classification Catalog" also classifies medical protective masks as Class II medical devices.
According to the relevant provisions of the Regulations for the Supervision and Administration of Medical Devices (Revised in 2017), Class II medical devices are of medium risk and require strict control and management. According to the regulations, foreign enterprises exporting Class II medical devices to China should obtain the approval and registration of the state pharmaceutical supervision department, and the products should be inspected and qualified by the medical device inspection organization with the corresponding inspection report, as well as Chinese manuals and Chinese labels. Therefore, the import of N95 medical masks is strictly regulated by the state.
Two, in the epidemic situation, the State Drug Administration opened a green emergency channel: emergency import of medical devices not registered in China
Recently, in order to urgently import medical devices not registered in China, to ensure the supply of medical equipment urgently needed to fight the epidemic, the State Drug Administration, the Division of Medical Devices Supervision and Administration issued the "on the emergency import of medical devices not registered in China's views", that is, from the The State Drug Administration Medical Devices Supervision and Management Division issued the "Opinions on the Emergency Import of Medical Devices Not Registered in China", that is, the emergency import of medical devices from abroad in line with the relevant standards of the United States, the European Union and Japan, the enterprise can provide overseas medical devices listed on the documents and inspection reports, and to make a commitment to the quality and safety of the product can be used in emergency.
Jiangsu Provincial Bureau of Pharmaceutical Supervision also launched the export of medical protective clothing, medical masks to domestic epidemic prevention and control of emergency use for the record. Province engaged in the export of medical protective clothing, medical mask production enterprises can contact the Jiangsu Provincial Medical Device Inspection Institute, submit the record materials, Jiangsu Provincial Bureau of Pharmaceutical Supervision according to the inspection, on-site inspection, etc., to clarify whether the product has the conditions for the record.
Third, the source of the masks purchased on behalf of the unknown, many are counterfeit products, if the use of masks carrying germs security risks
On behalf of the masks purchased on behalf of the source of the unknown, the security risks are great, there may be falsely claimed to be imported from abroad, in fact, for the domestic factories to counterfeit the famous brand of the "three no products". For example, the counterfeit American "3M masks" with forged trademarks and logos are often made of inferior filter materials with substandard filtration performance; they may also be recycled masks with obvious stains and secondary utilization; and they may even be masks produced by unscrupulous factories with substandard quality.
According to the official disclosure of the seized cases of fake masks, most of the fake masks production workshop does not have any sterilization equipment, not to mention the environment in line with the production of masks, there are only bare hands packing masks employees. Worthy of vigilance is that many fake masks have flowed into the shopping circle! If consumers wear such masks, not only can not play a protective role, but also cause greater health risks.
Here, generous to remind you: the purchase of masks if indeed belongs to the purchase from overseas, in many cases there is no corresponding Chinese labels and Chinese manuals, is not imported medical devices, the general public is difficult to identify the real source, is not recommended to use!
On behalf of the purchase of masks if it is a regular medical surgical masks, has been registered by the relevant state departments, then its packaging will have a product registration number, with the corresponding Chinese labels and Chinese instructions. The specific query is: log on to the State Drug Administration, click on the medical device query.
Four, the operation, the use of N95 medical protective masks not registered or not filed, may face the corresponding administrative penalties, and even criminal liability
As mentioned earlier, the State Drug Administration has issued a policy for the U.S. FDA approval has been obtained, the European Union CE marking of medical devices and Japan's medical device marketing authorization, but has not completed the registration of imported medical devices of the NMPA device. open a green emergency channel.
If an individual sells N95 masks purchased from overseas, according to Article 30 of the "Regulations for the Supervision and Administration of Medical Devices (2017 Revision)", it may constitute a case of selling Class II medical devices without filing, and will bear the administrative responsibility of "ordering correction and imposing a fine of less than 10,000 yuan".