
May 24, 2023
FDA
The new article addresses the aspects related to the way the need in a new marketing submission should be determined and to the implementation of modifications. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the...
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Aug 3, 2021
Asia
The Health Sciences Authority (HSA), Singapore’s agency responsible for regulations in the sphere of healthcare products, has published a guidance document dedicated to the medical device unique device identification (UDI) system. Table of Contents Apart from the...
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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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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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May 26, 2021
EU MDR/IVDR
Today marks a landmark event for medical device manufacturers around the globe: the date of full implementation of the EU’s MDR. Starting today all new medical device registrations that fall within the scope of the European Medical Device Regulation (MDR) must be...
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