The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
Sponsors seeking EU authorization to market fixed-dose drug combinations should conduct multiarm, randomized, controlled trials comparing the FDC with its individual components, the European Medicines Agency says. Read More
Devicemakers won’t have to stage new clinical trials of their devices to gain approval in China if they can demonstrate that they’re basically equivalent to devices already on the market, the Chinese regulators say. Read More