Tag: Medical Devices

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

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

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

Medical Device

USA Accreditation Scheme for Conformity Assessment (ASCA) The Center for Devices and Radiological Health’s (CDRH) Division of Standards and Conformity Assessment (DSCA) encourages medical...

Compliance, Global Health, Health Policy, Healthcare Industry, Medical Devices, Medical Technology, Regulations, Regulatory Updates

Medical Devices – Europe, Asia and ROW Regulatory News – Feb. 2024

Medical Device

EUROPE Expression of interest open – Possible second call for EU reference laboratories for high-risk in vitro diagnostic medical devices The Commission, after consulting the Member States in...

Compliance, Global Health, Health Policy, Healthcare Industry, Medical Devices, Medical Technology, Regulations, Regulatory Updates

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

Medical Devices – USA/Europe Regulatory News – Dec. 2023

Medical Device

USA Food and Drug Administration issued Guidance for Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions Guidance describes a nine-step framework...

Clinical Trial, Europe Regulatory News, IVDR, MDR, Medical Devices, Regulatory News, USA Regulatory News