The state of the medical device according to the risk of the implementation of classification management.
Class I:
is a low-risk, routine management can ensure the safety and effectiveness of medical devices. For example, scalpels, surgical scissors, gauze bandages, medical ice packs, stethoscopes and so on.The second category:
is a moderate risk, need to strictly control the management to ensure its safety and effectiveness of medical devices. For example, thermometers, sphygmomanometers, electrocardiographs, nebulizers, etc. are common in our daily lives.Class III:
is a higher risk, need to take special measures to strictly control the management to ensure its safety and effectiveness of medical devices. For example, common contact lenses, syringes, intravenous needles, cardiac stents, respiratory machines, CT, nuclear magnetic **** vibration and so on.Medical device license is now post approval, valid for 5 years. The expiration of the validity of the need for continuation, in accordance with the relevant administrative licensing laws and regulations for the continuation of the procedures.
Three types of medical devicesknowMaterials required for the registration of mechanical licenses
1, business name and scope of business, registered capital and shareholders' contribution ratio, shareholders and other identification; 2, medical equipment Product registration certificate, supplier business license, permit and authorization; 3, quality management documents; 4, two or more medical professionals or related professional certificates, identification and resume; 5, in line with the requirements of the medical device business office space and warehouse certificate; 6, articles of association, shareholders' meeting resolution; 7, financial personnel identification and Induction certificate; 8, other related materials.Two, for three backclass medical device license requirements:
1, site requirements: must be office nature, the use of an area of less than 45 square meters; 2, personnel requirements: the need to have three related personnel (the head of the company, the head of quality, quality inspection). The person in charge of the company, the person in charge of quality, quality inspectors) for the record and hold a certificate; 3, product requirements: there must be in line with the business scope of the product information, and issue certificates; 4, other relevant laws and regulations.Three, for three types of medical devices license AnswerCertificate process:
1, the applicant submits an application for information to the relevant departments; 2, the relevant departments to accept the applicant's Application; 3, to the actual site for investigation and review of the product; 4, granted the issue of three types of medical device license. The above is the three types of medical equipment license to do the relevant introduction, the procedure may be more cumbersome. You can consult me at any time if you don't understand. If you do not know what type of product you are, you can call me at any time to give you proper advice. To get a medical license, you need to have the relevant personnel, warehouse address, and product number, we can provide you with.For the record of the second category you need to provide:
Legal identity information Quality personnel identity information The company's business license and the official seal The warehouse address material