Category: Medical Device

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

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

ANVISA New Medical Device Regulation RDC 751/2022

June 27, 2023
Medical Device

On March 1st, 2023, the new RDC (Resolution of the Collegiate Board) 751/2022 released by the Brazilian National Health Surveillance Agency (ANVISA) went into force. The fundamental goal of the...

ANVISA, Brazil Healthcare, Compliance Standards, EU MDR Regulation, Medical Device Regulation, RDC751, SaMD

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

FDA Regulations for Medical Device Approval in USA

May 29, 2023
Medical Device

FDA’s Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, re-label, and/or import medical devices sold in the United States. In addition,...

FDA Medical Devices, Medical Device Approval, Pre-market Notification, Quality System Requirements, USA FDA Regulations