Tag: Med Tech

Medical Devices – USA, Europe, Asia and ROW Regulatory News – May 2025

Medical Device

USA Guidance Document: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program The aim of this guidance document is to outline the various mechanisms available...

Compliance, Digital Health, EU Regulations, FDA, Global Health, Healthcare Innovation, Med Tech, Medical Devices, Regulatory Affairs, UDI

2024 Recap: Medical Device key Regulation/Guidance in USA, EU, Asia and ROW

Medical Device

USA EUROPE AUSTRALIA BRAZIL CANADA CHINA COLUMBIA CZECH-REPUBLIC FINLAND FRANCE GERMANY HONG-KONG HUNGARY ICELAND INDIA IRELAND ...

Asia, Device Compliance, EU, Global Health Healthcare Standards, Global Trends, Guidance, Health Tech, IVDR, MDR, Med Tech, Medical Device Regulations, Medical Devices, Medical Innovation, Regulations, Regulatory Compliance, Regulatory Updates, ROW, USA

MHRA Issues Transparency for Machine Learning and Medical Devices

Medical Device

The Medicines and Healthcare Products Regulatory Agency (MHRA) has published guiding principles for machine learning medical devices, focusing on transparency. According to the MHRA guidance, “These...

AI, Device Performance, Digital Health, Healthcare Transparency, Innovation In Healthcare, Machine Learning, Med Tech, Medical Devices, MHRA, Regulatory Guidelines

Medical Devices – USA, Europe, Asia and ROW Regulatory News – June 2024

Medical Device

USA Guidance on Laboratory Developed Tests: Small Entity Compliance Guide FDA released a final rule in the Federal Register entitled “Medical Devices; Laboratory Developed Tests” (89 FR 37286)...

.Device Regulation, Compliance, EU, FDA, Global Health, Guidance, Health Care, June2024, Med Tech, Medical Devices, Regulatory News