Category: Medical Device

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

September 4, 2024
Medical Device

USA Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers The VMSR (Voluntary Malfunction Summary Reporting) Program allows device manufacturers to report certain device...

Asia Regulations, Europe Regulations, Global Compliance, Global Regulatory Updates, Healthcare Regulations, Medical Device Regulations, Medical Devices, Regulatory Updates, USA Regulations

Medical Devices – USA, Europe and ROW Regulatory News – July 2024

August 6, 2024
Medical Device

USA Medical Device User Fee Rates for Fiscal Year 2025 The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for the fiscal year...

Clinical Guidance, Clinical Updates, Device Regulation, Medical Devices, Medical News, Medical Regulations, Regulatory Updates

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

July 30, 2024
Medical Device

The European Health Data Space is a health specific ecosystem comprised of rules, common standards and practices, infrastructures and a governance framework that aims at: 1. Empowering individuals...

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

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

July 4, 2024
Medical Device

USA Guidance on Laboratory Developed Tests: Small Entity Compliance Guide FDA published a final rule in the Federal Register entitled “Medical Devices; Laboratory Developed Tests”...

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

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

June 5, 2024
Medical Device

USA Remanufacturing of Medical Devices- Guidance for Industry, Entities That Perform Servicing or Remanufacturing, and Food and Drug Administration Staff The guidance is intended to help clarify...

Compliance, eCTD, Global Health, Health Policy, IVDs, Medical Devices, Medical Technology, Regulations, Regulatory Updates

Real World Evidence in Medical Device to Support Regulatory Decisions

May 8, 2024
Medical Device

Real-world evidence (RWE) refers to data regarding the use, effectiveness, and safety of medical products (such as drugs, biologics, and medical devices) that is derived from real-world sources, including...