Tag: Medical Technology

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

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

April 3, 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

March 5, 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