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22 Sep 2025 | AnnouncementsCall for Comments on the Proposed Document 'UDI Application Guidance Considerations for Manufacture to facilitate an effective UDI Implementation'
22 Sep 2025 | AnnouncementsCall for Comments on the Proposed Document 'Playbook for Design and Implementation of Active Post-Market Surveillance System'
22 Sep 2025 | AnnouncementsCall for Comments on the Proposed Document 'Definition and Classification of Field Corrective Actions, including Field Safety Corrective Actions, Recalls and Non-Safety related Field Corrective Actions'
16 Sep 2025 | AnnouncementsCall for Comments on the Proposed Document 'Guidance on Determining of Lead Authority and Communication Process for Combination Products'
15 Sep 2025 | AnnouncementsCall for Comments on 'GHWP Strategic Framework for Medical Device Regulation 2030'
12 Sep 2025 | AnnouncementsProposed Final Document: Amendment 10 (R2) to GHWP TOR and House Rules
2 Sep 2025 | AnnouncementsCall for Comments on the Proposed Document 'Guidance on Pre-market submission requirement for artificial intelligence/machine learning based computer-assisted detection (CADe) and computer-assisted diagnosis (CADx) software as a medical device'
20 Aug 2025 | AnnouncementsCapacity Building – Free online training on Change Management by Dr. Adelheid Schneider and Mr. Sharad Shukla on 27th August 2025