At the beginning of May, the State Food and Drug Administration issued a "Notice on Regulating the Illegal Business Activities in the Circulation of Drugs", requiring local governments to carry out centralized rectification of illegal business operations in the field of drug circulation. Among them, the announcement requires all pharmaceutical wholesale enterprises to conduct self-examination first, for the enterprise. Whether there are 10 aspects of suspected adjacency, ticketing, etc., will be checked. After the start of the drug circulation inspection, the inspection of medical equipment will also be picked up.
On May 5th, in order to further strengthen the quality management of medical equipment that needs to be refrigerated and frozen, and ensure that such medical equipment meets the specifications or labeling requirements during storage and transportation, Sichuan Province carries out cold chain management of medical equipment management enterprises in the province. supervised check. This inspection combines the specific requirements for the supervision and inspection of the storage and transportation management of refrigerated and frozen medical devices, and conducts comprehensive supervision and inspection for enterprises engaged in the operation of refrigerated and frozen medical devices.
On May 9th, Tongling City of Anhui Province issued the “Work Plan for the Supervision and Inspection of Cold Chain Management of Medical Device Management Enterprises in Tongling Cityâ€, focusing on the inspection of legal qualifications, warehousing management, cold chain transportation, quality traceability and personnel training.
On May 11th, in order to further strengthen the quality management of refrigerated and frozen medical devices and ensure product quality and safety, Lanzhou Food and Drug Administration issued the "Implementation Plan for Medical Device Cold Chain Management Supervision and Inspection" to produce and operate medical devices. Use the chain cold chain management to supervise and inspect, and urge enterprises to implement the management system for refrigerated and frozen medical devices.
On May 13, the Yunnan Food and Drug Administration issued the "Special Supervision and Inspection Work Plan for Cold Chain Management of Medical Device Management Enterprises", requiring the provincial food and drug supervision and management department to concentrate on the supervision and management of the cold chain management of medical device management enterprises. Special supervision and inspection are carried out from legal qualifications, warehouse management, cold chain transportation, quality traceability and personnel training.
In addition, Shanghai, Guizhou Liupanshui, Xi'an and other places have recently launched a medical equipment cold chain inspection... In all of these inspections, the Lanzhou Municipal Food and Drug Administration's "medical equipment cold chain management supervision and inspection implementation plan" (hereinafter referred to as the implementation plan) is the "most slap in hand", the implementation plan is clear, in the special action for 2 months, a comprehensive inspection of the medical device operation links, the key inspection contents include "passing tickets, passing tickets Illegal acts."
Specific inspection: "Is there any cover for the sale of illegally purchased frozen and frozen medical devices through the rental, lending, transfer of licenses, bills, virtual invoicing, non-invoicing, counterfeit receipts and the establishment of multiple computer systems, resulting in the sale of illegally purchased frozen medical devices Unknown sources of medical devices entering the distribution channel."
It is understood that the Lanzhou Municipal Food and Drug Administration is the first major department to explicitly crack down on the ticketing and ticketing behaviors of medical device management. It is also rare to conduct a comprehensive inspection of the production, operation and use of medical devices.
However, not all cities and counties in Gansu Province will check the votes and tickets like Lanzhou. For example, Jiuquan City and Linxia Prefecture, in their respective medical cold chain management supervision programs, did not propose to check the tickets, travel tickets, but also for the business enterprises to carry out major inspections.
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