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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Mar 16, 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 labeling rules for medical devices introduced by the...
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Nov 16, 2020
Asia
Thailand Food and Drug Administration (FDA), the country’s regulating authority in the sphere of medical devices, has published several guidelines dedicated to certain important aspects related to the marketing of medical devices in Thailand. In particular, the new...
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Jun 29, 2020
Europe
The Slovenian Agency for Medicinal Products and Medical Devices (JAZMP) issued guidance dedicated to the regulatory requirements of protective elements on colored drawings on medical device packages. In particular, the document describes specific aspects to be...
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