Tag: Medical Devices

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

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

Medical Device

USA Guidance on Institutional Review Board (IRB) Written Procedures The FDA and HHS OHRP have jointly issued the final guidance on Institutional Review Board (IRB) Written Procedures to enhance...

Asia Regulations, Europe Regulations, Global Regulatory, Healthcare Regulations, Med Tech Updates, Medical Device News, Medical Devices, Regulatory Updates, ROW Regulatory, USA Regulations

Standards updates for last 6 months

Standards

Medical device standards are a set of guidelines and requirements that ensure the safety, effectiveness, and quality of medical devices. These standards are established by various international and...

ANSI Standards, ASTM Standards, Device Compliance, Healthcare Standards, ISO Standards, Labeling, Medical Device Standards, Medical Devices, Regulatory Updates, Sterilization

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

European Health Data Space’s implications for “Wellness Apps” & Medical Devices

Medical Device

The European Health Data Space is a health specific ecosystem comprised of rules, common standards The European Health Data Space (EHDS) is a specialized health ecosystem built on shared rules, standards,...

AI in Healthcare, Digital Health, Electronic Health Records (EHR), GDPR Compliance, Health Data Security, HealthTech Regulations, Medical Devices, Preventive Healthcare, Wellness Apps

Recap 2023 : Key Medical Device Regulatory highlights in Asia and ROW

Medical Device

ASIA CHINA Notice from the Device Review Center of the State Food and Drug Administration on the release of key points for the functional review of artificial intelligence software for magnetic...

Healthcare Compliance, Medical Devices, Regulatory Updates

Tag: Medical Devices

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

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

Standards updates for last 6 months

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

Recap 2023 : Key Medical Device Regulatory highlights in Asia and ROW

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