Hunan standard medical device quality management

From November 23, the Hunan Provincial Food and Drug Administration held a meeting on the quality management of medical device production. It was learned that the province officially initiated the work on quality management of medical devices.

According to Li Chiqun, deputy director of the province's Food and Drug Administration, starting from July 1st next year, the province will focus on the implementation of "medical device production" for 66 manufacturers of aseptic medical devices, implantable medical devices and in vitro diagnostic reagents. Management specifications. In addition to being the basis for on-site assessment prior to the registration of medical devices, the “Code” is also an important means for daily supervision and inspection of medical device manufacturing companies by food and drug regulatory agencies. At the inauguration meeting of the medical device production quality management specification of the medical device manufacturing enterprise, the Bureau also invited senior domestic experts to explain relevant regulations and standards.

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