Aug 12, 2021
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document dedicated to design control for medical devices. Due to its legal nature, an FDA guidance is a non-binding document...
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Aug 5, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has announced a public consultation on proposed amendments to the regulatory framework for medical devices that are substances introduced into the...
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Jul 12, 2021
Asia
The Health Sciences Authority (HSA), Singapore`s regulating authority in the sphere of medical devices and other healthcare products, has published a guidance document dedicated to the medical device unique device identification (UDI) system. The latest version of the...
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Jul 9, 2021
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices and other healthcare products, has published a safety communication dedicated to the reprocessing of flexible bronchoscopes. The document provides...
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Jul 8, 2021
Canada
Health Canada, the country’s regulating authority in the sphere of medical devices, has published a detailed guidance document describing the rules to be applied when determining the class of an in vitro diagnostic medical device (IVDD). The document provides an...
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