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Failure to file medical device reports with the FDA within the prescribed 30-day period after becoming aware that its glucose meter may have contributed to an injury landed South Korea’s Philosys a warning letter. Read More
TEAM-NB, the European Association of Notified Bodies for medical devices, reported that CE certificates spiked by nearly 50 percent last year. Read More
The Medical Device Innovation Consortium (MDIC) is asking for feedback on its new draft framework for using real-world evidence (RWE) in the development and clearance of in-vitro diagnostics (IVDs). Read More
The European Commission’s Medical Device Coordination Group (MDCG) outlined in a new guidance how devicemakers should report safety incidents for clinical studies under the new Medical Device Regulation. Read More
Australia’s Therapeutic Goods Administration is conducting domestic good manufacturing inspections remotely in place of on-site inspections during the COVID-19 pandemic. 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