Tag: IVDR

2024 Recap: Medical Device key Regulation/Guidance in USA, EU, Asia and ROW

December 16, 2024
Medical Device

USA EUROPE AUSTRALIA BRAZIL CANADA CHINA COLUMBIA CZECH-REPUBLIC FINLAND FRANCE GERMANY HONG-KONG HUNGARY ICELAND INDIA IRELAND ...

Asia, Device Compliance, EU, Global Health Healthcare Standards, Global Trends, Guidance, Health Tech, IVDR, MDR, Med Tech, Medical Device Regulations, Medical Devices, Medical Innovation, Regulations, Regulatory Compliance, Regulatory Updates, ROW, USA

Medical Devices – USA/Europe Regulatory News – Dec. 2023

December 6, 2023
Medical Device

USA Food and Drug Administration issued Guidance for Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions Guidance describes a nine-step framework...

Clinical Trial, Europe Regulatory News, IVDR, MDR, Medical Devices, Regulatory News, USA Regulatory News

Medical Devices-USA/Europe Regulatory News – Nov 2023

November 7, 2023
Medical Device

USA Guiding Principles on Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices FDA, Health Canada, and MHRA jointly identified 5 guiding principles (Focused and bounded,...

Europe Regulatory News, IVDR, MDR, Medical Devices, Regulatory News, USA Regulatory News

Medical Devices-USA/Europe Regulatory News-October 2023

October 5, 2023
Medical Device

USA Electronic Submission Template for Medical Device 510(k) Submissions The FDA Electronic submission template for medical device guidance describes the technical standards associated with preparation...

Europe Regulatory News, IVDR, MDR, Medical Devices, Regulatory News, USA Regulatory News

Medical Devices – USA, Europe, Asia Regulatory News – Nov 2022

November 30, 2022
Medical Device

Asia Philippines FDA Publishes Circular on The Abridged Processing of Medical Devices Registration with Approval by The NRA of Any ASEAN Member Country Philippines FDA issues Circular No. 2022-008...

Asia, Devices, Europe, FDA, HSA, IVDR, Liver Cancer, MDCG, Regulatory News, South Africa, USA