Tag: Medical Devices

Medical Devices-USA/Europe Regulatory News-September 2023

September 6, 2023
Medical Device

USA (FDA) Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors The guidance is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors...

CE marking, Europe Regulatory News, in vitro diagnostics, Medical Devices, Regulatory News, USA Regulatory News, vigilance

Medical Devices-USA/Europe Regulatory News – August 2023

August 3, 2023
Medical Device

USA (FDA) Medical Device User Fee Rates for Fiscal Year 2024 The FD&C Act, as amended by MDUFA V, authorizes FDA to collect user fees for certain medical device submissions and annual fees...

Europe Regulatory News, Harmonised standards, Medical Devices, Regulatory News, Software as a Medical Device (SaMD), USA Regulatory News

Medical Devices-Asia and ROW Regulatory News-July 2023

July 25, 2023
Medical Device

ASIA SINGAPORE (HSA) HSA’s SRA status for In-vitro Diagnostic Medical Devices (IVD) An SRA is a national health products regulatory authority considered by the WHO to apply stringent...

Asia Regulatory News, IVD, Medical Devices, Regulatory News, ROW Regulatory News

Regulatory Intelligence shows path to the Success in Pharma Industry

July 21, 2023
Biopharma

Pharma companies need to be well-versed regarding regulatory intelligence while develop, manufacture and release products into the market. Companies have to analyze, monitor and gather the information...

Compliance, Healthcare, Medical Devices, Pharma Industry, Regulatory Intelligence, Regulatory Updates

Medical Devices-USA/Europe Regulatory News-July 2023

July 11, 2023
Medical Device

USA (FDA) Content of Premarket Submissions for Device Software Functions The purposes of this document, FDA refers to a software function that meets the definition of a device as a device software...

Europe Regulatory News, FDA, HPRA, Medical Devices, MHRA, Premarket Approval (PMA), Regulatory News, USA Regulatory News

Medical Devices-Asia and ROW Regulatory News-June 2023

June 20, 2023
Medical Device

ASIA INDIA (CDSCO) 2023.06.02_MDR_Final G.S.R. 409(E)_Amendment in Rule 18 and 19 for notifying State MDTL The State Government may, by notification, establish State Medical Devices Testing...

Asia Regulatory News, Implantable Medical Devices, In-vitro Diagnostic, IVD, Medical Devices, Regulatory News, ROW Regulatory News