Jul 9 - 5:50
According to the MDR requirements, Notified Bodies (NB) should be designated to maintain operations connected with the registration process and perform other supervisory actions. In the course of these medical device...
Jul 8 - 6:23
On Friday, the European Medicines Agency (EMA) released two guidance documents addressing issues surrounding drug shortages in the EU, and how to manage drug shortages publicly. These documents were created by a task...
Jul 2 - 3:11
European medical device regulating authority, the European Commission, issued two additional guidance. They expand on certain application aspects of Medical Device Regulation and in vitro Diagnostic Device Regulation....
Jun 28 - 4:44
Health Canada, the Canadian medical regulating authority, announced that new requirements, which was under development since 2018, came into effect this week. The scope of new requirements covers issues related to...
Jun 26 - 4:43
Previously in 2014, the FDA has published a final guidance discussing premarket expectations but the constant technology advancements and changes requires a new guidance. As a result, on October 18, 2018, the FDA...
