According to the "supervision and management of medical equipment business approach", engaged in the operation of medical equipment business enterprises should have with the scope of business and business scale of the quality management organization or quality management personnel, quality management personnel should have a nationally recognized relevant professional qualifications or titles.
1, the person in charge of quality should have medical device related professional (related professional refers to medical devices, biomedical engineering, medicine, bioengineering, chemistry, pharmacy, nursing, testing, etc.) college degree or above or intermediate or above professional and technical title, and should have more than 3 years of experience in quality management of medical device business.
2, engaged in in vitro diagnostic reagents quality management personnel, there should be a supervisor of the inspector, or with a university degree or higher in testing related disciplines and engaged in testing related work for more than 3 years of work experience. In vitro diagnostic reagents acceptance and after-sales service personnel, should have a secondary school education in laboratory-related disciplines or with a junior or above the professional and technical title of inspector.
3, engaged in implantable and interventional medical devices business personnel should be equipped with medical related college degree or above, and through the production enterprises or suppliers of training personnel.
4, engaged in corneal contact lenses, implantable hearing aids and other medical devices with special requirements of the business personnel should be equipped with relevant professional or vocational qualifications.
5, the enterprise warehouse management, sales and other staff, should have a high school or junior college education.
What are the administrative licensing content of the medical device license
1, review and issuance of a new "medical device business license" (second and third class medical devices)
2, the second class, the third class of medical devices business enterprise merger, separation, or across the original jurisdiction of the relocation of
Legal basis: "Medical Device Supervision and Administration Regulations" XXVII, "Medical Device Supervision and Administration Regulations". Supervision and Management of Medical Devices Regulations" Article 29: engaged in the operation of medical equipment, there should be with the scale and scope of business operations and storage conditions, as well as with the operation of medical devices and quality management system and quality management organizations or personnel.
"Supervision and Administration of Medical Devices Regulations" Article 34: medical device users should have with the use of medical devices, the number of varieties, storage space and conditions appropriate to the use of medical devices.
Medical devices should be used to strengthen the technical training of staff, in accordance with product instructions, technical specifications and other requirements for the use of medical devices. Medical equipment using units configured with large medical equipment, should be in line with the State Council competent department of health planning for large medical equipment configuration planning, and its functional positioning, clinical service needs, with the appropriate technical conditions, supporting facilities and have the appropriate qualifications, ability of professional and technical personnel, and by the people's government at or above the provincial level of the competent department of health planning for approval, to obtain the configuration of large-scale medical equipment licenses.