Saudi Arabia
The Saudi Food and Drug Authority (SFDA), Saudi Arabia`s authority for medical devices regulation, issued guidance dedicated to the field safety corrective actions. Regulatory Background The present SFDA guidance is intended to provide additional information and...
MHRA
The Medicines and Healthcare products Regulatory Agency (MHRA), UK’s authority responsible for the regulation of medical devices, issued guidance on field safety notices (FSNs). The document is intended to assist medical device manufacturers in preparing the...
Europe
European medical regulating authority, the EC, recently published a new guidance on medical device vigilance systems covering issues related to the distribution of information between national competent authorities. The document, intended to clarify definitions, set...
