Sep 13, 2021
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published detailed guidelines describing recalls, corrections, and removals in the context of medical devices. The document is intended to...
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Sep 8, 2021
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document on reprocessing medical devices in healthcare settings. The document highlights the most important aspects...
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Aug 25, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published a guidance document that addresses the information accompanying (active) implantable medical devices, including patient information...
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Aug 9, 2021
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a general guidance document dedicated to labeling for medical devices. The document describes in detail the general labeling...
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Aug 6, 2021
Canada
Health Canada, the country’s regulating authority in the sphere of healthcare products, has published a guidance document dedicated to incident reporting for medical devices. The document is intended to assist medical device manufacturers and other parties involved in...
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