Tag: Medical Devices

Medical Devices-Asia and ROW Regulatory News-June 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

Medical Devices-USA/Europe Regulatory News – May 2023

Medical Device

USA (FDA) Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters – Premarket Notification (510(k)) Submissions)-Guidance for Industry and Food and Drug Administration Staff This...

Europe Regulatory News, Health Canada, Medical Devices, MHRA, Regulatory News, Swissmedic, US FDA, USA Regulatory News

Medical Devices-Asia and ROW Regulatory News – April 2023

Medical Device

ASIA MALAYSIA (NPRA) Declaration of Worldwide Registration Status for Generic Medicines Malaysia now requires all new applications for Generic Medicines (Prescription – Full) to include a declaration...

Asia Regulatory News, Medical Devices, Regulatory News, ROW Regulatory News, SaMD, Software as a Medical Device

Medical Devices-USA/Europe Regulatory News – April 2023

Medical Device

USA Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices and Related Systems Under Section 524B of the FD&C Act-Guidance Document for Industry and Food and Drug Administration...

Europe Regulatory News, FIMEA, HPRA, Medical Devices, MHRA, Regulatory News, Swissmedic, US FDA, USA Regulatory News

Medical Devices – Asia and ROW Regulatory News – March 2023

Medical Device

JAPAN (PMDA) Medical Safety Measures for Pharmaceuticals and Medical Devices The Ministry of Health, Labour and Welfare (MHLW) continues efforts to reduce medical accidents by improving the...

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

Medical Devices-USA/Europe Regulatory News – March 2023

Medical Device

USA (FDA) Laser Products – Compliance with IEC 60825-1 and IEC 60601-2-22 (Laser Notice No. 56) FDA has issued guidance clarifying its expectations for manufacturer compliance with U.S. performance...

Canada Regulatory News, Europe Regulatory News, FIMEA, HPRA, Medical Devices, MHRA, Regulatory News, Swissmedic, US FDA, USA Regulatory News