Mar 14, 2021
Kazakhstan
The National Center for Expertise of Medicines and Medical Devices (NDDA), Kazakhstan’s body responsible for the assessment of quality and safety of medical devices, has published an official notice on the rules for inspections with regard to medical devices. New...
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Jun 29, 2020
FDA
The Food and Drug Administration (FDA or the Agency) issued updated guidance on processes and standards for the inspections of medical device establishments. Inspections Regulatory Backgrounds The new approach to medical device establishment inspections is based on...
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May 19, 2020
COVID-19
The World Health Organization (WHO), the international organization focused on public health protection, issued a notice providing medical device manufacturers and industry representatives additional information that addresses COVID-19-related issues. The document...
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