Tag: Regulations

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
Consumer Health

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

China’s CMDE Announces New Regulations on the Supervision and Administration of Customized Medical Devices for Clinical Trials

January 22, 2020
Medical Device

The Center of Medical Device Evolution (CMDE) of China has released a regulation (notification 53) that clarifies the requirements for the definition, listing, design, processing, usage, supervision...

China, Medical Device, Regulations