Recently, the Municipal Food and Drug Administration has further strengthened the supervision of in vitro diagnostic reagents according to the requirements of Fujian Province on strengthening the supervision of in vitro diagnostic reagents. Up to now, the city has trained more than 500 people and inspected 165 medical device operators.

The bureau took the promotion of the "Measures for the Supervision and Administration of Medical Device Use Quality" as an opportunity to do a good job in the "Quality Management Standards for Medical Device Management" and "Guidelines for the Management of Cold Chain Transportation and Storage of Medical Devices", which enhanced the company's awareness of law-abiding and integrity. Consciousness has improved the overall level of medical device supervision in the city. On the basis of comprehensive inspections by the county (district) and the supervised departments, a combination of spot checks, supervision and interviews and guidance will be adopted to comprehensively promote the implementation of special rectification work for in vitro diagnostic reagents. Focusing on the investigation and management of expired use, failure, elimination of medical equipment and cold chain violation management, comprehensive investigation and punishment of medical equipment violations.

Up to now, the city has trained more than 500 people, checking 2 medical device manufacturers, 165 operating companies, 61 using units, interviewing and guiding 52 enterprises, proposing 93 rectification opinions, and urging the cancellation of one enterprise and nuclear reduction. There are 3 business scopes, and 1 case of illegal cases was handed over to Sanming Bureau. 13 hospitals and 9 wholesale enterprises were given warnings, 9 cases of expired medical devices were investigated, and 1 case of in vitro diagnostic reagents were not investigated according to storage conditions, the case value was 0.4 million yuan, and the fine was 190,000 yuan; Qualified enterprises purchased 2 drugs for quasi-font type diagnostic reagents, with a case value of 123,000 yuan, and the case is being processed. Through strict supervision and punishment measures, we will comprehensively promote the standardized management of in vitro diagnostic reagents in our city.

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