Category: Medical Device

Medical Devices-USA/Europe Regulatory News – May 2023

May 3, 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

April 18, 2023
Medical Device

ASIA INDIA (CDSCO) Circular for Licensing of Class C & D medical devices According to the Circular It is pertinent to mention that as per Medical Devices rules (MDR) 2017 manufacturing...

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

MDR Regulations – Impact on Medical Devices

April 18, 2023
Medical Device

The EU Medical Device Regulation (MDR) has been in effect since May 26, 2021 and has had a significant impact on the global medical device industry. Below mentioned are the 7 ways the...

Medical Devices-USA/Europe Regulatory News – April 2023

April 4, 2023
Medical Device

USA (FDA) Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices and Related Systems Under Section 524B of the FD&C Act-Guidance 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

March 21, 2023
Medical Device

JAPAN (PMDA) Medical safety measures related to pharmaceuticals and medical devices The Ministry of Health, Labor and Welfare is promoting various efforts to prevent medical accidents, but it...

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

Medical Devices-USA/Europe Regulatory News – March 2023

March 2, 2023
Medical Device

USA (US FDA) Laser Products – Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56)-Guidance for Industry and Food and Drug Administration Staff The guidance...

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