An enterprise owner consulted through WeChat: Hello, lawyer! Our company is preparing to produce masks. What qualifications do you need? Lawyer Li Ruiyu of Fujian Pengyi Law Firm answers: The types of masks are divided into: ordinary masks, disposable medical masks, medical surgical masks, particle protective masks, medical protective masks, gas masks, etc. The production standards and regulatory requirements are different for different mask types: 1. KN95/N95 and above particle protective masks belong to non medical masks, which are special labor protection articles, while non medical masks are produced. The State Council has cancelled the management of production license for industrial products of special labor protection articles. Therefore, enterprises producing non medical masks no longer need to apply for production license for industrial products (QS certification), It is not subject to the supervision and management of the medical device supervision and management system. However, production enterprises should not ignore the obligations of product quality and safety assurance, production conditions, production standards, quality control, etc., and should strictly implement national standards for production. 2. Medical masks (medical surgical masks and medical protective masks) belong to the second class of medical devices, which involve professional and industrial knowledge in the medical field. The state adopts strict legal supervision, and the manufacturing enterprises should go through qualification application and filing procedures in strict accordance with the relevant provisions of the state. Otherwise, they may not produce, sell, operate or resell without permission. Therefore, if the enterprise wants to produce medical masks, it must obtain the administrative license of the food and drug supervision and administration department, and the medical masks it produces should also obtain the Medical Device Registration Certificate, so that it can meet the qualification requirements for producing medical masks. If medical masks are produced without permission or without medical device registration certificate, according to Article 63 of the Regulations on the Supervision and Administration of Medical Devices, the food and drug administration of the people's government at or above the county level shall confiscate the illegal income, medical devices illegally produced and operated, tools, equipment, raw materials and other articles used for illegal production and operation; If the value of medical instruments illegally produced and operated is less than 10000 yuan, a fine of 50000 yuan to 100000 yuan shall be imposed; If the value of goods is more than 10000 yuan, a fine of 10 times to 20 times the value of goods shall be imposed; If the circumstances are serious, the medical device license application submitted by the relevant responsible person and enterprise will not be accepted within 5 years. (Arranged by Jiang Ruixin) "Lawyer Online" In their daily life, many citizens often do not know how to take up legal weapons to safeguard their rights when they encounter violations of various legal rights and interests. In order to give full play to the important functions of lawyers and new media in law popularization, education, resolving disputes, promoting fairness and justice, maintaining social stability, etc., explore and practice the "lawyers+new media" solution to problems, respond to new programs for the masses, promote the improvement of the level of rule of law in all areas of society in the Internet era, and promote the improvement of grass-roots social governance politics, rule of law, rule of virtue, autonomy The "Five Governance Integration" system of intelligent governance and good governance, the Political and Legal Committee of Putian Municipal Committee, the Municipal Bureau of Justice, the Municipal Law Society, the Municipal Lawyers Association, and the Putian Station of Southeast Network jointly carried out the "Lawyers Online" activity throughout the city. If citizens encounter various disputes in their daily life, they do not know whether their legal rights and interests have been infringed, and how to protect their rights and interests if they have been infringed, they can all report relevant legal issues to Southeast China Lawyers Online through the following channels, and we will invite lawyers to answer relevant legal questions for you in a timely manner. 1. Follow the "Putian Southeast Network" or "Justice Putian" WeChat public account, enter the keyword "Lawyer" in the dialog box, and then enter the "Lawyer Online" column to leave a message. 2. Call the news hotline 0594-2535366 of Putian Station of the Southeast Network. 3. Reflected through the official Weibo message on Putian Station of Sina Weibo Southeast Network. |
