The first class of medical devices is a low-risk, the implementation of routine management can ensure the safety and effectiveness of medical devices, such as scalpels, surgical scissors, manual beds, medical ice packs, cooling patches, and so on, the products and production activities by the municipal food and drug regulatory authorities in the region to implement the management of the record. Business activities are all liberalized, neither permit nor record, only need to obtain a business license issued by the business sector.
The second class of medical devices is a moderate risk, need to strictly control the management to ensure its safety and effectiveness of medical devices, such as band-aids, condoms, thermometers, sphygmomanometers, oxygen concentrators, nebulizers, etc., its products and production activities by the provincial food and drug regulatory departments to implement licensing management, were issued by the "Medical Device Registration Certificate" and "Medical Device Production License". License". Business activities by the municipal food and drug regulatory departments to implement the record management;
The third class of medical devices is a higher risk, need to take special measures to strictly control the management of medical devices to ensure their safety and effectiveness, such as common infusion sets, syringes, intravenous needles, cardiac stents, respiratory machines, CT, MRI *** vibration, etc., the products and production and management activities by the State Administration, the provincial food and drug regulatory departments and the State Administration of Food and Drug Administration, the provincial food and drug regulatory departments, and the State Administration of Food and Drug Administration, the provincial food and drug regulatory departments and the State Administration of Food and Drug Administration. General Administration, provincial food and drug regulatory authorities and municipal food and drug regulatory authorities to implement licensing management, respectively, issued by the "Medical Device Registration Certificate", "Medical Device Manufacturing License", "Medical Device Business License". Individuals to do not familiar with the process often run a lot of trips to do not down, do not understand can consult the editor.
Mask production conditions
1, with the production of medical devices compatible with the production site, environmental conditions, production equipment and professional and technical personnel;
2, the enterprise should have with the production of emergency filing products and production scale of the production of production equipment, production, warehousing sites and the environment (already has a dust-free sterile workshop);
3, the production of emergency record of medical devices for quality inspection of the organization or full-time inspectors and inspection equipment;
4, the enterprise's production, quality and technical personnel should have the production of medical devices and the production of appropriate professional competence, and to master the national supervision and management of medical devices and related product quality, technical regulations, quality shall not be responsible for At the same time as the person in charge of production
Frontier temperature gun for the conditions
1, with the production of medical devices compatible with the production site, environmental conditions, production equipment, and professional and technical personnel;
2, the enterprise should have with the production of emergency filing products and the production scale of the production of production equipment, production, warehousing sites and the environment (already have a constant-temperature room and buffer room, a constant-temperature sink, a black body, a black body, a black body, a black body, a black body, a black body, a black body, a black body, a black body and a black body. Constant temperature sink, black body, special constant temperature air conditioning, standard parts and other facilities are complete);
3, there is the production of emergency filing of medical devices for quality inspection of the organization or full-time inspectors and inspection equipment;
4, the enterprise's production, quality and technical personnel should have the production and production of medical devices with the appropriate professional competence, and master the national supervision and management of medical equipment The laws, rules and regulations and related product quality, technical regulations, the person in charge of quality shall not be concurrently responsible for the production of
Note:
Enterprise responsible person requirements: with medical devices related professional (related professional refers to medical devices, biomedical engineering, mechanical, electronic, medical, bioengineering, chemistry, pharmacy, nursing, rehabilitation, testing, management and other professions, hereinafter the same) college degree or higher or a bachelor's degree or higher, or the same. Hereinafter the same) college degree or above, or intermediate or above professional and technical title, at the same time should have more than 3 years of medical device business quality management experience.
The above is the mask, forehead temperature gun for the conditions, want to know more about the medical device production license process and information, you can contact the editor oh