International – IMDRF guidance aims to harmonize, streamline review reports
The International Medical Device Regulators Forum (IMDRF) recently published guidance intended to streamline regulatory reporting requirements across jurisdictions. The document lays out expectations not...
International – IMDRF publishes updated guides covering governance activities and membership
The International Medical Device Regulators Forum (IMDRF) recently posted a series of updated guidelines on the group’s standard operating procedures (SOP), criteria for joining,...
International – Enfin une norme internationale sur le dosage des EEB spécifique aux DM...
La série de normes ISO 11737, qui décrit les méthodes microbiologiques associées à la stérilisation des produits de santé, se déclinera dorénavant en trois...
Israel – New study use musical tests for early detection of cognitive decline
“Our method enables routine monitoring and early detection of cognitive decline in order to provide treatment and prevent rapid, severe deterioration,” said the researchers...
International – MDSAP policy for remote quality system audits to expire in September 2022
Medical device market regulators participating in the Medical Device Single Audit Program (MDSAP) plan to end COVID-19-era policies allowing remote audits of quality management...
South Africa – South African regulators issue guidance for medical device imports, advertising
The South African Health Products Authority (SAHPRA) has issued several new regulatory documents that medical device and in vitro diagnostic (IVD) device manufacturers should...
Saudi Arabia – Saudi FDA postpones Unique Device Identification compliance deadlines
The Saudi Food and Drug Authority (SFDA), Saudi Arabia’s medical device market regulator, has once again announced the postponement of its Unique Device Identification (UDI) requirements...
International – Des valves cardiaques imprimées en 3D
Une équipe internationale germano-australienne a mis au point des valves cardiaques artificielles imprimées en 3D, conçues pour permettre aux propres cellules d’un patient de...
International – IMDRF proposes legacy device cybersecurity guidance after stakeholder feedback
Communication between manufacturers and healthcare providers is key to ensuring patients with legacy medical devices are kept safe according to proposed cybersecurity guidance from...
International – Révision de la norme ISO 10993-17 : quelles évolutions ?
L’évaluation biologique des dispositifs médicaux est réalisée selon les normes de la série ISO 10993 et repose sur un processus de gestion des risques....
