May 25, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published guidelines describing the process of inclusion of medical devices in the national register. The present guidelines describe: The process...
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Nov 13, 2019
Europe
The European Commission has announced the extension of the application period for medical device and in vitro diagnostic device expert panels. It is intended that experts will be able to provide technical and scientific advice in regards to applications and medical...
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Sep 20, 2019
North America
The FDA has finalized a guidance about citizen petitions against the approval of drugs, which delays the application process, and what they look for in petition submissions as well as why submissions might be denied. This comes after the abundant number of false...
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Sep 12, 2019
North America
The Food and Drugs Administration (FDA), the US authorized body who provides regulation and supervision in the sphere of medical products and devices, finalized a guidance on De Novo applications. De Novo Pathway De Novo is a special procedure applied for new market...
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Aug 23, 2019
EU MDR/IVDR
All medical device manufacturers should be aware that the last CE certificate renewal deadline expires later this month. Those who miss it could face regulatory issues, delays, and additional expenses. CE Certificate Renewal Requirements According to the...
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