FDA seek to harmonize human subject protections with revised Common Rule
The US Food and Drug Administration (FDA) on Tuesday issued two proposed rules aimed at harmonizing certain sections of the agency’s regulations on human...
Europe – 34ème Organisme Notifié
ENTE CERTIFICAZIONE MACCHINE SRL
Via Ca’ Bella, 243/A - loc. Castello di Serravalle
40053 Valsamoggia (BO)
Country : Italy
Taiwan – Taiwan’s MOHW issues draft revision of UDI requirements; draft amendment of the...
Taiwan’s Ministry of Health and Welfare (MOHW) has issued Announcement No. 1111610130 and Announcement No. 1111606650 (links in Chinese) to commence the public consultations for the abolition of...
USA – Stakeholders seek flexibility, greater harmonization in FDA human subject protection rules
Commenters from the pharmaceutical and medical device industries, academia and medical groups urged the US Food and Drug Administration (FDA) to help ease the...
Europe – Council votes unanimously to extend MDR deadlines
The European Council (EC) has approved a measure to extend the transition period for medical devices under the Medical Devices Regulation (MDR) and to...
Europe – Euro Convergence: Experts call for more IVD-specific guidance during IVDR transition
Notified body representatives say that when regulators develop guidance for the In Vitro Diagnostics Regulation (IVDR) they need to get more input from IVD...
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...
Europe – New guidance from European MDCG ahead of date of application
European regulators have issued several new guidance documents relevant to medical device and in vitro diagnostic (IVD) manufacturers days before the In Vitro Diagnostic...
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...
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...
