Jan 5, 2022
Asia
The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of medical devices and other healthcare products, has published a FAQ document dedicated to 3D-printed medical devices. The document provides additional clarifications on the applicable...
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Nov 3, 2021
Asia
The Health Sciences Authority (HSA), Singapore’s regulating authority in the sphere of healthcare products, has published a guidance document dedicated to medical devices manufactured by using the 3D-printing technology. The document is intended to provide additional...
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Sep 16, 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 denture base resins. In particular, the document addresses the aspects...
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Jul 22, 2021
Canada
Health Canada, the country’s regulating authority in the sphere of medical devices, has published a guidance document dedicated to medical device recalls. The document is intended to provide additional clarifications regarding the applicable regulatory requirements...
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Aug 4, 2020
Australia and Oceania
The Therapeutic Goods Administration (TGA), an Australian regulating authority responsible for medical devices, has issued a guidance document dedicated to the use of three dimensional (3-D) printing (an additive manufacturing process). Technology Overview and...
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