Tag: Medical Devices

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

Medical Devices-Asia and ROW Regulatory News-Feb 2023

February 16, 2023
Medical Device

CHINA (CFMDE-NMPA) Announcement of the State Food and Drug Administration on Issuing YY/T 1888-2023 “Recombinant Humanized Collagen” Medical Device Industry Standard (2023 No. 14) The...

Asia Regulatory News, Baharain Regulatory News, China Regulatory News, Malayasia Regulatory News, Medical Devices, Panama Regulatory News, Philippines Regulatory News, Regulatory News, Saudi Arabia Regulatory News

Medical Devices-Asia and ROW Regulatory News-Jan 2023

January 19, 2023
Medical Device

INDIA (CDSCO) Registration of Medical Device Testing Laboratory in Form MD-40 as per Medical Devices Rules (MDR) 2017 for Testing of Medical Devices on behalf of the manufacturer In order to...

Asia Regulatory News, Baharain Regulatory News, China Regulatory News, Hong Kong Regulatory News, India Regulatory News, Malayasia Regulatory News, Medical Devices, Regulatory News, Saudi Arabia Regulatory News

Medical Devices-USA/Europe Regulatory News – Jan 2023

January 4, 2023
Medical Device

EUROPE MDCG 2022-21 – Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745 The guidance is applicable to medical devices which have been certified under...

Europe Regulatory News, Medical Devices, Regulatory News, USA Regulatory News