EU MDR/IVDR
The Health Products Regulatory Authority (HPRA), the Irish regulating authority in the sphere of medicines and medical devices, has published a draft guidance document dedicated to new applications for wholesale distribution authorizations (WDAs), as well as...
Canada
Health Canada, the country’s regulating authority in the sphere of medical devices, has published updated guidance on incident reporting for medical devices. The present document supersedes the previous version issued by the authority earlier in October 2011. Due to...
FDA
The Food and Drug Administration (FDA) has published an information sheet guidance describing the regulatory aspects related to the Significant Risk and Nonsignificant Risk medical device studies. The document is intended to provide additional clarifications and...
IMDRF
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices, has announced public consultations related to the document issued recently by the IMDRF. The International Medical Device Regulators Forum (IMDRF), a...
Saudi Arabia
The Saudi Food and Drug Authority (SFDA), the country’s regulating authority in the sphere of medical devices, has published a guidance document dedicated to the approach to be applied for bundling/grouping medical devices intended to be marketed and used in the...
