Aug 20, 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 labeling requirements. The aspects covered by the scope of the guidance include labeling requirements for...
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Aug 18, 2021
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a detailed guidance document dedicated to labeling requirements for various types of medical devices, including in vitro diagnostic...
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Aug 13, 2021
Canada
Health Canada, the country’s regulating authority in the sphere of medical devices, has published a guidance document dedicated to ultrasound diagnostic systems and transducers. The present article covers aspects related to the labeling of such products and also...
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Jul 21, 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 guidance document dedicated to the unique device identification system. In particular, the document is...
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Apr 28, 2021
Uncategorized
The Saudi Food and Drug Authority (SFDA), the country’s regulating authority in the sphere of medical devices, has published guidance dedicated to the labeling requirements medical devices should comply with in order to be allowed for marketing and use. Regulatory...
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