punish
01
Recently, the Henan Provincial Drug Administration issued a notice on the flight inspection of some medical device manufacturers in 2021 (No. 3 of 2022). In 2021, in accordance with the Measures for flight inspection of pharmaceutical and medical devices and the Specifications for Flight Inspection of Medical Device Manufacturers, the Henan Provincial Drug Administration organized flight inspections of some key supervised medical device manufacturers.
In view of the different product characteristics and risk types of enterprises, the Henan Provincial Food and Drug Administration formulated an inspection plan, in accordance with the requirements of medical device production quality management standards and supporting laws and regulations, focusing on inspecting the implementation of the main responsibility of quality and safety, product quality and safety management of enterprises, and conducting a comprehensive inspection of key links such as procurement, production process, product inspection and product traceability. For the problems and clues found in the inspection, the inspection team has handed over to the local regulatory department of the medical device manufacturer to investigate and deal with it according to the relevant provisions of the Regulations on the Supervision and Administration of Medical Devices, the Measures for the Supervision and Administration of the Production of Medical Devices, and the Good Manufacturing Practices for Medical Devices. At the same time, urge enterprises to rectify existing problems.
Among them, 33 companies were notified of flight inspections by the Henan Provincial Drug Administration. Henan Fu Ruide Medical Equipment Co., Ltd. was required to stop production and rectify, Henan Shenlan Jingxing Optoelectronic Technology Co., Ltd. was required to take the initiative to stop production, and 31 companies such as Zhengzhou Antu Biological Engineering Co., Ltd. were required to rectify within a time limit.
Source: China Economics Network Finance, IVD Information, In Vitro Diagnostic Network
overseas
02
On February 7, BGI Gene disclosed that the new crown antigen self-test product of its wholly-owned subsidiary BGI Europe A/S (hereinafter referred to as European Medicine) recently obtained the EU CE certificate.
The product that obtained the EU CE access qualification is the novel coronavirus antigen detection kit (colloidal gold method), which is intended to be used for the qualitative detection of the new coronavirus (SARS-CoV-2) in nasal swab samples before the onset of suspected cases of novel coronavirus infection in vitro, which assists in assessing the infection status and clinical diagnosis of the new coronavirus, and is suitable for home self-testing.
Source: Beijing News, IVD Information
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