In order to further standardize the operation order of medical devices, strengthen supervision, and crack down on illegal and illegal activities, the Municipal Food and Drug Administration issued a notice recently, and decided to carry out centralized rectification of illegal business operations in the field of medical device circulation in the city. It is understood that this centralized rectification focuses on "three synchronizations": simultaneous development of "playing, preventing, and building", cracking down on illegal and illegal behaviors, comprehensively preventing potential risks of quality and safety risks, establishing and improving a long-term regulatory mechanism; simultaneously strengthening scientific popularization and building The atmosphere of social co-governance; simultaneous special training to improve the supervision ability of grassroots supervisors on the operation of medical devices. According to the work schedule, all enterprises engaged in the second and third types of medical device management shall conduct self-inspection of the medical device operation behavior since June 1, 2014, and the list of related problems: sales of business enterprises engaged in medical device wholesale business For non-qualified business enterprises or users; medical device operating enterprises never purchase medical equipment from qualified production and operation enterprises; operating conditions change, no longer meet the requirements of medical device management quality management norms, not in accordance with regulations Renovation; unauthorized change of business premises or warehouse address, expansion of business scope or the establishment of warehouses without authorization. Detailed description of the existing problems, manual methods, medical equipment and personnel involved, carefully formulate rectification measures and plans, form a self-examination and rectification report, and report to the district/county food and drug supervision department before July 15. The legal representative of the enterprise shall report the bookmark word, affix its official seal, and make a commitment to the truthfulness, completeness and rectification of the report. The food and drug supervision departments of all districts and counties shall promptly notify all medical device operating enterprises within their jurisdictions to submit self-inspection and rectification reports on time, and inspect the format, authenticity and integrity of the reports. Medical device operators can take the initiative to find problems before July 15, 2016, and at the same time correct their violations, they can be lightened or mitigated according to law; if they fail to report, the food and drug supervision departments of all districts and counties will open the list of enterprises to the public. It is listed as the key inspection object; for those who refuse to report, report false reports and self-examination, and the rectification is not in place, strictly, from re-examination, until the revocation of the "Medical Device Business License". YT-H706 YT-H706 Shenzhen Sunshine Technology Co.,Ltd , https://www.szyatwin.com
Xi'an Food and Drug Administration will focus on rectifying violations of laws and regulations in the field of medical device circulation