The operation of Class II products is required to apply for Class II medical device business filing certificate, the operation of Class III products need to apply for a medical device business license. The difference between the two is as follows:
One, the second class of business filing certificate needs to be filed, while the medical device business license is the approval system.
Two, the second class of medical devices business filing certificate office address sampling, medical device business enterprise license office address shall be verified, the requirements of the medical device management system is complete, complete personnel, office, warehouse equipment, cold storage in line with the acceptance criteria.
Three, the application conditions are different:
1, the application for the second class of medical devices business record certificate and medical device business license medical device manufacturers should have the following conditions:
(1) in line with the "supervision and management of the production of medical devices," Article VII, Article VIII of the regulations;
(2) the enterprise's production, quality and technical The person in charge of production, quality and technology should have with the production of medical devices appropriate professional competence, the person in charge of quality shall not be concurrently in charge of production;
(3) with the production of products and production scale of the production of equipment, production, warehousing sites and the environment. Enterprises producing medical devices have special requirements for the environment and equipment, should be in line with national standards, industry standards and relevant state regulations;
(4) with the production of varieties and production scale of quality inspection organizations and quality inspection capacity;
(5) with the production of medical devices related to technical standards.
2, apply for a medical device license business enterprises, in addition to the above requirements should be met, but also should have the following conditions:
(1) meet the quality management system requirements of the internal auditor not less than two;
(2) related professional title or college degree or above, not less than two full-time technical staff.
Expanded:
Medical devices are divided into three categories: Class I, Class II and Class III, and at present the operation of Class I products are not required to apply for a medical device ware business license.
The state of medical devices in accordance with the degree of risk of the implementation of classification and management is as follows:
The first category is a low degree of risk, the implementation of routine management can ensure the safety and effectiveness of medical devices. Such as: surgical instruments (knife, scissors, pliers, tweezers, hooks), scraping board, medical X-ray film, surgical gowns, surgical caps, examination gloves, gauze bandages, drainage bags 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. Such as: medical suture needles, sphygmomanometers, thermometers, electrocardiographs, electroencephalograms, microscopes, acupuncture needles, biochemical analysis systems, hearing aids, ultrasound disinfection equipment, non-absorbable sutures, condoms and so on.
The third category is a higher risk, need to take special measures to strictly control the management to ensure its safety and effectiveness of medical devices. Such as: implantable cardiac pacemakers, corneal contact lenses, artificial crystals, ultrasound tumor focusing knife, hemodialysis devices, implantable devices, vascular stents, comprehensive anesthesia machine, dental implant materials, medical absorbable sutures, intravascular catheters and so on.
References:
Baidu Encyclopedia - Class II Medical Device Business Record
Baidu Encyclopedia - Medical Device Business License