--- title: Regulatory Affairs Advance | Regulatory Affairs (3) description: Regulatory Affairs | To be noticed Medical Device Regulatory Affairs updates and discussions from leaders in the field. (3) --- [Skip to content](https://blog.arazygroup.com/regulatory-affairs-advance/tag/regulatory-affairs/page/3#main-content) # Blog [![](https://blog.arazygroup.com/hubfs/China-1.jpg)](https://blog.arazygroup.com/regulatory-affairs-advance/cmde-releases-key-guidelines-for-clinical-evaluation-of-medical-devices) [Regulatory Affairs](https://blog.arazygroup.com/regulatory-affairs-advance/tag/regulatory-affairs), [Regulatory Update](https://blog.arazygroup.com/regulatory-affairs-advance/tag/regulatory-update) ## [CMDE Releases Key Guidelines for Clinical Evaluation of Medical Devices](https://blog.arazygroup.com/regulatory-affairs-advance/cmde-releases-key-guidelines-for-clinical-evaluation-of-medical-devices) [Arazy Group](https://blog.arazygroup.com/regulatory-affairs-advance/author/arazy-group) May 13, 2024, 10:57:19 AM On March 18, 2024, the Center for Medical Device Evaluation (CMDE) released an important Notice that... [Read more](https://blog.arazygroup.com/regulatory-affairs-advance/cmde-releases-key-guidelines-for-clinical-evaluation-of-medical-devices) [![](https://blog.arazygroup.com/hubfs/iStock-1968100820.jpg)](https://blog.arazygroup.com/regulatory-affairs-advance/eu-ai-act-passes-final-approval) [Regulatory Affairs](https://blog.arazygroup.com/regulatory-affairs-advance/tag/regulatory-affairs), [AI](https://blog.arazygroup.com/regulatory-affairs-advance/tag/ai) ## [EU's AI Act Clears Final Hurdle: Shaping Future AI Regulations](https://blog.arazygroup.com/regulatory-affairs-advance/eu-ai-act-passes-final-approval) [Miki Melech](https://blog.arazygroup.com/regulatory-affairs-advance/author/miki-melech) Mar 15, 2024, 2:25:55 PM Exciting news from the EU as the "AI Act" receives final approval, ushering in comprehensive regulat... [Read more](https://blog.arazygroup.com/regulatory-affairs-advance/eu-ai-act-passes-final-approval) [![](https://blog.arazygroup.com/hubfs/Saudi_Arabia.jpg)](https://blog.arazygroup.com/regulatory-affairs-advance/regulatory-update-saudi-arabia) [Regulatory Affairs](https://blog.arazygroup.com/regulatory-affairs-advance/tag/regulatory-affairs), [Regulatory Update](https://blog.arazygroup.com/regulatory-affairs-advance/tag/regulatory-update) ## [Regulatory Update: Saudi Arabia](https://blog.arazygroup.com/regulatory-affairs-advance/regulatory-update-saudi-arabia) [Arazy Group](https://blog.arazygroup.com/regulatory-affairs-advance/author/arazy-group) Feb 7, 2024, 12:28:22 PM On February 5, 2024, the Saudi Food & Drug Authority (SFDA) marked a significant milestone with the ... [Read more](https://blog.arazygroup.com/regulatory-affairs-advance/regulatory-update-saudi-arabia) [![](https://blog.arazygroup.com/hubfs/Brazil.jpg)](https://blog.arazygroup.com/regulatory-affairs-advance/regulatory-update-brazil-1) [Regulatory Affairs](https://blog.arazygroup.com/regulatory-affairs-advance/tag/regulatory-affairs), [Regulatory Update](https://blog.arazygroup.com/regulatory-affairs-advance/tag/regulatory-update) ## [Regulatory Update: Brazil](https://blog.arazygroup.com/regulatory-affairs-advance/regulatory-update-brazil-1) [Arazy Group](https://blog.arazygroup.com/regulatory-affairs-advance/author/arazy-group) Jan 29, 2024, 12:10:59 PM In Brazil, a significant regulatory development in the realm of healthcare emerged with the issuance... [Read more](https://blog.arazygroup.com/regulatory-affairs-advance/regulatory-update-brazil-1) [![](https://blog.arazygroup.com/hubfs/iStock-1425131504.jpg)](https://blog.arazygroup.com/regulatory-affairs-advance/european-commission-proposes-extension-for-ivdr-compliance-prioritizing-patient-care) [Regulatory Affairs](https://blog.arazygroup.com/regulatory-affairs-advance/tag/regulatory-affairs), [Regulatory Update](https://blog.arazygroup.com/regulatory-affairs-advance/tag/regulatory-update) ## [European Commission Proposes Extension for IVDR Compliance, Prioritizing Patient Care](https://blog.arazygroup.com/regulatory-affairs-advance/european-commission-proposes-extension-for-ivdr-compliance-prioritizing-patient-care) [Arazy Group](https://blog.arazygroup.com/regulatory-affairs-advance/author/arazy-group) Jan 24, 2024, 10:29:25 AM In a significant move to enhance patient care and transparency within the medical devices sector, th... [Read more](https://blog.arazygroup.com/regulatory-affairs-advance/european-commission-proposes-extension-for-ivdr-compliance-prioritizing-patient-care) [![](https://blog.arazygroup.com/hubfs/iStock-1444934349.jpg)](https://blog.arazygroup.com/regulatory-affairs-advance/swissmedic-releases-revised-meddo-and-ivdo) [Regulatory Affairs](https://blog.arazygroup.com/regulatory-affairs-advance/tag/regulatory-affairs), [Regulatory Update](https://blog.arazygroup.com/regulatory-affairs-advance/tag/regulatory-update) ## [Swissmedic Releases Revised MedDO and IvDO](https://blog.arazygroup.com/regulatory-affairs-advance/swissmedic-releases-revised-meddo-and-ivdo) [Arazy Group](https://blog.arazygroup.com/regulatory-affairs-advance/author/arazy-group) Oct 13, 2023, 1:35:09 PM On September 29, 2023, Swissmedica released new requirements for product groups without an intended ... [Read more](https://blog.arazygroup.com/regulatory-affairs-advance/swissmedic-releases-revised-meddo-and-ivdo) [![](https://blog.arazygroup.com/hubfs/imgpsh_fullsize_anim-Sep-19-2023-08-12-00-2003-PM.jpg)](https://blog.arazygroup.com/regulatory-affairs-advance/the-art-and-science-of-regulatory-affairs) [Regulatory Affairs](https://blog.arazygroup.com/regulatory-affairs-advance/tag/regulatory-affairs), [Medtech](https://blog.arazygroup.com/regulatory-affairs-advance/tag/medtech), [Creativity](https://blog.arazygroup.com/regulatory-affairs-advance/tag/creativity) ## [The Art and Science of Regulatory Affairs](https://blog.arazygroup.com/regulatory-affairs-advance/the-art-and-science-of-regulatory-affairs) [Benjamin Arazy](https://blog.arazygroup.com/regulatory-affairs-advance/author/benjamin-arazy) Sep 19, 2023, 1:12:07 PM [Read more](https://blog.arazygroup.com/regulatory-affairs-advance/the-art-and-science-of-regulatory-affairs) [![](https://blog.arazygroup.com/hubfs/iStock-1454458749.jpg)](https://blog.arazygroup.com/regulatory-affairs-advance/regulatory-news-health-canada-releases-new-guidance-on-medical-device-regulation) [Regulatory Affairs](https://blog.arazygroup.com/regulatory-affairs-advance/tag/regulatory-affairs), [Regulatory Update](https://blog.arazygroup.com/regulatory-affairs-advance/tag/regulatory-update) ## [Regulatory News: Health Canada Releases New Guidance on Medical Device Regulation](https://blog.arazygroup.com/regulatory-affairs-advance/regulatory-news-health-canada-releases-new-guidance-on-medical-device-regulation) [Arazy Group](https://blog.arazygroup.com/regulatory-affairs-advance/author/arazy-group) Sep 13, 2023, 2:38:28 PM Health Canada has published three key updates: Guidance on medical device establishment licensing (G... [Read more](https://blog.arazygroup.com/regulatory-affairs-advance/regulatory-news-health-canada-releases-new-guidance-on-medical-device-regulation) [![](https://blog.arazygroup.com/hubfs/imgpsh_fullsize_anim-1-1.jpg)](https://blog.arazygroup.com/regulatory-affairs-advance/regulatory-update-malaysia) [Regulatory Affairs](https://blog.arazygroup.com/regulatory-affairs-advance/tag/regulatory-affairs), [Regulatory Update](https://blog.arazygroup.com/regulatory-affairs-advance/tag/regulatory-update) ## [Regulatory Update: Malaysia](https://blog.arazygroup.com/regulatory-affairs-advance/regulatory-update-malaysia) [Arazy Group](https://blog.arazygroup.com/regulatory-affairs-advance/author/arazy-group) Sep 12, 2023, 2:59:29 PM In response to the ongoing global health crisis, Malaysia has taken a significant step forward in th... [Read more](https://blog.arazygroup.com/regulatory-affairs-advance/regulatory-update-malaysia) [![](https://blog.arazygroup.com/hubfs/imgpsh_fullsize_anim-2-1.jpg)](https://blog.arazygroup.com/regulatory-affairs-advance/regulatory-update-turkey) [Regulatory Affairs](https://blog.arazygroup.com/regulatory-affairs-advance/tag/regulatory-affairs), [Regulatory Update](https://blog.arazygroup.com/regulatory-affairs-advance/tag/regulatory-update) ## [Regulatory Update: Turkey](https://blog.arazygroup.com/regulatory-affairs-advance/regulatory-update-turkey) [Arazy Group](https://blog.arazygroup.com/regulatory-affairs-advance/author/arazy-group) Sep 12, 2023, 2:57:12 PM A Guideline for the Withdrawal and Recall of Medical Devices and In Vitro Diagnostic Devices from th... 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