The 24th GHWP Annual Meeting was successfully held in Muscat, Oman, on 11-14 November 2019. Please find the presentation materials below: Download file 20191111 - 01 - Medical Device Regulatory Framework 20191111 - 02 - AHWP-APACMed Competency Framework White Paper 20191111 - 03 - Track101 - Pre Market Reviews 20191111 - 03 - Track102 - Essential Principles of Safety and Performance 20191111 - 03 - Track103 - Risk Classification GMD and IVD and CSDT 20191111 - 03 - Track104 - Product Grouping GMD and IVD 20191111 - 03 - Track105 - Step wise approach Expedited routes - examples _Referencing and Reliance 20191111 - 03 - Track106 - Post market surveillance_investigation_change management 20191111 - 03 - Track201 - Credibility and Impact on the applicability of the Real World Evidence 20191111 - 03 - Track202 - Regulatory pathways and clinical evidence requirements for Companion Diagnostics 20191111 - 03 - Track203 - UDI_Past, Present, Future 20191111 - 03 - Track204 - Rise of Digital Health Innovation and what it means for the Regulators 20191111 - 03 - Track205 - Digital Transformation in regulatory processes 20191111 - 03 - Track206 - Artificial Intelligence_Global Regulatory Development 20191111 - 03 - Track207 - Regulatory Guidelines for Artificial Intelligence-based Medical Devices 20191111 - 03 - Track208 - Artificial Intelligence_Application in the Hospital_its Technology and Benefits 20191111 - 03 - Track209 - Reliance The future of Medical device regulations 20191112 - 01 - General Overview on Cybersecurity trends around the Globe 20191112 - 02 - DITTA Activities in Cybersecurity and Update on IMDRF Work Item on Cybersecurity 20191112 - 03 - AHWP recent work on UDI_China NMPA Final UDI Rules for Medical Device 20191112 - 04 - Saudi Arabia UDI Rules for Medical Devices and Implementation Experience 20191112 - 05 - Chinese Taipei Experience in Implementation of UDI and Lessons Learned and Benefits Realized from UDI Adoption 20191112 - 06 - Global Medical Device Nomenclature GMDN_its Structure and its Applications in UDI and Electronic Health Records 20191112 - 07 - Key Updates on ISO13485_2016 Quality Management System for Medical Devices 20191112 - 08 - Implementation of Risk Based Approach in a Manufacturer to Meet ISO13485_2016 20191113 - 01 - AHWP Strategic Planning Towards Harmonisation 20191113 - 02 - AHWP WG Updates 20191114 - 01 - AHWP Overall Status Report01 20191114 - 02 - AHWP Overall Status Report02 20191114 - 03 - AHWPTC Overall Status Report 20191114 - 04 - IMDRF Member Country Harmonization Efforts_MDSAP 20191114 - 05 - IMDRF Member Country Harmonization Efforts_International Regulatory Cooperations 20191114 - 06 - IMDRF Status Update 20191114 - 07 - International Organizations Updates_APEC 20191114 - 08 - International Organizations Updates_ASEAN 20191114 - 09 - International Organizations Updates_African Medical Devices forum_former PAHWP 20191114 - 10 - International Organizations Updates_WHO Prequalification of in vitro diagnostics 20191114 - 11 - International Organizations Updates_WHO Medicines and Health Products Department 20191114 - 12 - AHWP Liaison Member Updates_APACMed 20191114 - 13 - AHWP Liaison Member Updates_DITTA 20191114 - 14 - AHWP Liaison Member Updates_GS1 20191114 - 15 - AHWP Member Country or Region Updates_China 20191114 - 16 - AHWP Member Country or Region Updates_Saudi Arabia 20191114 - 17 - AHWP Member Country or Region Updates_South Korea 20191114 - 18 - AHWP Member Country or Region Updates_Sultanate of Oman 20191114 - 19 - AHWP Member Country or Region Updates_Kyrgyz Republic 20191114 - 20 - AHWP Secretariat Updates_Secretariat Report 20191114 - 21 - Resolution and Endorsement
