Medical Device Professional Qualification Examination System Should Be Established

In recent years, the rapid development of medical device technology, a large number of new high-tech medical devices into the market, greatly improving the level of medical treatment. At the same time, this also places higher demands on practitioners in the medical device industry. It is worth noting that in the new round of institutional reforms, the State Food and Drug Administration has expanded the original Medical Device Supervision and Administration Division to the Medical Device Registration Management Division and the Medical Device Supervision Division, and the number of personnel has nearly doubled. Under the simplistic environment of government agencies, this fully demonstrates the importance that the state attaches to the medical device industry.

The medical device industry involves many disciplines and complex technologies. However, China has yet to establish a unified system of professional qualification examination for employees in the medical device industry. Currently in the industry with a certain degree of influence in qualifying examinations are the clinical medical engineering and technology examinations organized by the health department and the medical equipment industry early and intermediate professional technical qualification examinations organized by the Zhejiang Food and Drug Administration. However, the former is only a social assessment test. The examination scope is limited to 10 provinces (autonomous regions and municipalities) including Shanghai, Jiangsu, Tibet, and Shaanxi. Most of the test subjects come from medical institutions; the latter is limited to Zhejiang Province, and coverage is very small. . Their social recognition is limited and they cannot meet the requirements of the medical device industry. These situations lead to the lack of judgment standards for employers in the selection and employment of employees, which affects the overall quality of employees, and employees are hindered in terms of career development, promotion of titles, etc., which in turn makes the original shortage of personnel more unstable. The medical equipment laws and regulations also lack the basis for identifying the qualifications of employees, which is detrimental to the standardization of the equipment industry.

The author believes that the time has come to establish a uniform medical device qualification examination system in China. First of all, the qualification examination in Zhejiang Province has a certain role of demonstration. The province divides the examination into medical mechanical engineering, medical optical and electrical engineering, medical radiology imaging engineering, medical biochemical engineering, and medical device clinical engineering. This ensures the professionalism of the practitioners and the feasibility of the examination. In recent years, a large number of professionals who passed the qualification examination have played an important role in the development of the medical device industry in the province. Second, China's medical device regulatory system has been operating well for many years. The establishment of a unified national medical device qualification certification system can further strengthen the authority of supervision. Moreover, after the State Food and Drug Administration returns to the direct management of the State Council, it can formulate departmental regulations and establish a professional qualification examination system for medical devices. The legal obstacles have been removed. Third, with the revision of the new “Regulations on the Supervision and Management of Medical Devices,” the regulatory authorities can gradually establish a system for admitting medical device qualifications, which will legally limit the minimum number of qualified medical device operators in the production, operation and use of medical devices. The quantity will fundamentally ensure the professional and standardized medical device industry.