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The FDA said sponsors of emergency-use injectors should include details in their marketing applications to show that the devices are reliable. Read More
Australia’s Therapeutic Goods Administration (TGA) fined Oxymed Australia A$63,000 ($40,000) for making false claims that its hyperbaric oxygen therapy chambers can treat a variety of conditions, including COVID-19. Read More
To expand their availability during the pandemic, the FDA has temporarily relaxed its regulations on the use of certain digital pathology devices in laboratories. Read More
The European Commission has adopted a proposal to delay implementation of the EU Medical Device Regulation (MDR) for a year due to the COVID-19 pandemic. Read More
The International Medical Device Regulators Forum (IMDRF) released final guidance on harmonized regulations for adverse event reporting, cybersecurity, and personalized medical devices. Read More
Brazil’s National Health Surveillance Agency (ANVISA) is expediting approvals for medical devices and in vitro diagnostics related to the COVID-19 pandemic. Read More
The UK’s Medicines and healthcare Regulatory Agency (MHRA) is focused on building diagnostic capability for COVID-19 infections and is ramping up testing facilities across the UK via partnerships with universities, research institutes, diagnostics manufacturers and companies like Amazon and Boots. Read More
The European Commission’s Medical Device Coordination Group (MDCG) released new guidance for devicemakers on regulatory requirements for equivalent devices. Read More
The International Medical Device Regulators Forum (IMDRF) released final guidance on harmonized regulations for adverse event reporting, cybersecurity, and personalized medical devices. Read More