Jiangxi: The flight check is coming!
On June 22, the Jiangxi Provincial Food and Drug Administration issued the "Notice on Implementing the General Administration's Announcement on Regulating the Operational Behavior of the Medical Device Circulation Field", clearly proposing that in addition to the self-inspection of the enterprise and the supervision and inspection by the Municipal Food and Drug Administration, the provincial bureau also The company will conduct supervision on the centralized rectification work in various places in a timely manner, conduct self-inspection and rectification of enterprises, and adopt cross-checking methods to conduct targeted and focused flight inspections.
That is, the Jiangxi Provincial Food and Drug Administration will launch a flight inspection in the province's medical equipment operation.
Since the release of the "Measures for the Inspection of Drugs and Medical Devices", the flight inspection of medical device manufacturers has become normal, but the flight inspection of medical device manufacturers is relatively rare. For example, Jiangxi Province has only recently launched a flight inspection in the field of medical device circulation.
The provincial bureau organized the "first flight" in the field of medical device circulation
Date: 2016-06-22 08:45:00
In order to strengthen the supervision of medical device circulation, standardize the operation of medical devices, and focus on strengthening the sense of responsibility, quality awareness and risk awareness of enterprises, the provincial bureau has organized the supervision of cold chain management of medical device management enterprises in the province and in vitro. Diagnostic reagents and first flight inspections of high-risk medical device operators such as sterility and implantability.
This flight inspection adopts cross-checking method. 12 inspectors are randomly selected from the provincial inspector's library to form 6 inspection teams. The flight inspections are carried out on 17 key medical equipment wholesale enterprises in the province. The inspection coverage covers the whole province. Around the city. It is important to check whether the operating conditions are consistent with the approval of the license; whether the cold chain management of the refrigerated and frozen medical devices is required to be in compliance with the regulations; whether the products are purchased from the formal channels; whether there is a phenomenon of selling no registration certificates and exceeding the valid products.
From the inspection situation, through the vigorous publicity and education of the provincial medical bureau regulatory regulations in recent years, we have carried out a number of medical device special rectification actions such as “medical device five rectificationâ€, “in vitro diagnostic reagent quality assessment and comprehensive treatment workâ€, most of them. The awareness of corporate legal system has been significantly enhanced, business practices have been continuously regulated, and management levels have gradually improved. However, there are still a few enterprises that have problems in the management of medical devices that do not meet the requirements of medical device quality management regulations, arbitrarily change business premises, and require low-temperature cold chain management.
In the next step, the provincial bureau will instruct the relevant municipal bureaus to conduct follow-up inspections, supervise rectifications and investigate and deal with them according to the problems found in the inspection, and report the inspections. We will further promote the implementation of the “Announcement of the General Administration on Regulating the Operational Behavior of Medical Devices in the Field of Circulation†(No. 112 of 2016), severely crack down on illegal business operations, further standardize the business order in the circulation field, and ensure the safety and effectiveness of public use of machinery.
The first flight inspection for medical device operators has just been completed, and the Jiangxi Provincial Food and Drug Administration will once again launch a flight inspection in the medical equipment management. This is obviously to "train the soldiers." Moreover, "falling from the sky", not greeting, and more secret flight inspections, the inspection effect is better. Are the medical device operators in Jiangxi Province ready to take over?
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