Tag: Healthcare Regulations

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

March 11, 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

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

February 6, 2025
Medical Device

USA Guidance on Premarket Approval Application and Humanitarian Device Exemption Modular Review The guidance provides information on the Premarket Approval Application (PMA) and Humanitarian...

Device Approval, EU Regulations, FDA, Global Regulations, Healthcare Regulations, Innovation Healthcare, MDR2025, Medical Device, Medical Device Compliance, Medical Device Industry, Regulatory Affairs, Regulatory News, Regulatory Updates

2024 Recap: Consumer Health key Regulation/Guidance in USA, EU, Asia and ROW

December 17, 2024
Consumer Health

USA EUROPE ARGENTINA AUSTRALIA BRAZIL CHINA ISRAEL MALAYSIA PHILIPPINES SINGAPORE SWITZERLAND ul.countries { display:flex; list-style:...

Asia, Compliance, Consumer Health, Consumer Safety, EU, Global Health, Global Trends, Guidance, Health Compliance, Health Innovation, Health Policy, Health Standards., Health Updates, Healthcare Regulations, Medical Regulations, Pharma Regulations, Regulations, Regulatory Compliance, Regulatory Updates, ROW, USA

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