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| In vitro diagnostic reagents in our province comprehensive treatment and medical devices |
| Recently, provincial food and Drug Administration from the subordinate units and PUC deployed personnel composition inspection team, for the province to carry out "five rectification special action and medical equipment comprehensive management of in vitro diagnostic reagents" look back "work to carry on the comprehensive inspection. From the supervision of the situation, the province in vitro diagnostic reagents comprehensive management and medical equipment, five rectification special action to look back to work has achieved remarkable results. One is the organization's leadership and security. According to the unified arrangements of the administration and the Provincial Bureau, the provincial food and drug supervision departments at all levels to timely research and medical equipment comprehensive management of in vitro diagnostic reagents "five rectification special action, formulate" look back "specific embodiments, held a mobilization meeting, set up a" top leaders ", head of the special rectification work leading group, in vitro diagnostic reagent and the comprehensive management of medical devices" five rectification special action "look back" work listed as "top leaders" project, the principal leaders personally in command, directly responsible for the competent leadership, for the special treatment of deep development to provide a strong organizational guarantee. Two special governance is effective. Closely around the masses reflect strong hot and difficult issues, to take corporate self-examination, focus, daily inspection and acceptance of complaints and other ways, the area of medical equipment production, management, use and other aspects of the full range, three-dimensional centralized investigation and remediation, and eliminate all kinds of potential risks, and further standardize the use of medical equipment production and operation order, improve the quality and safety of medical equipment. Three is the working mechanism of innovation. Around the completion of the task at the completion of the higher level, and actively explore the establishment of a rich local characteristics of regulatory measures, continuous innovation and regulatory mechanism, and promote the regulatory thinking route passive remediation to the active prevention and control change. Nanchang Bureau formulated the medical equipment enterprise quality credit rating management approach "; Yichun City Bureau specially formulated for the in vitro diagnostic reagents purchase inspection" six prohibitions "Regulations" and "orthopedic implants ten management measures"; Jingdezhen City Council established the "admonishing conversation mechanism" and "blacklist mechanism" and disqualification mechanism three mechanism; Fuzhou City Bureau to implement the quality safety of medical devices "black list" system. [Next] [Back] |