Presentations at 24th AHWP Annual Meeting, Muscat, Oman, 11-14 November 2019


                                          
 

The 24th AHWP Annual Meeting was successfully held in Mucat, Oman, on 11-14 November 2019. Please find the presentation materials below: 

 

Day-1 (11 Nov 2019):

 Download file: 20191111-01-Medical Device Regulatory Framework.pdf  
 Download file: 20191111-02-AHWP-APACMed Competency Framework White Paper.pdf  
 Download file: 20191111-03-Track101-Pre Market Reviews.pdf
 
 Download file: 20191111-03-Track102 - Essential Principles of Safety and Performance.pdf 
 Download file: 20191111-03-Track103-Risk Classification GMD and IVD and CSDT.pdf  
 Download file: 20191111-03-Track104-Product Grouping GMD and IVD.pdf   
 Download file: 20191111-03-Track105-Step wise approach Expedited routes-examples_Referencing and Reliance.pdf    
 Download file: 20191111-03-Track106-Post market surveillance_investigation_change management.pdf     
 Download file: 20191111-03-Track201-Credibility and Impact on the applicability of the Real World Evidence.pdf      
 Download file: 20191111-03-Track202-Regulatory pathways and clinical evidence requirements for Companion Diagnostics.pdf      
 Download file: 20191111-03-Track203-UDI_Past,Present,Future.pdf       
 Download file: 20191111-03-Track204-Rise of Digital Health Innovation and what it means for the Regulators.pdf     
 Download file: 20191111-03-Track205-Digital Transformation in regulatory processes.pdf 
 Download file: 20191111-03-Track206-Artificial Intelligence_Global Regulatory Development.pdf 
 Download file: 20191111-03-Track207-Regulatory Guidelines for Artificial Intelligence-based Medical Devices.pdf 
 Download file: 20191111-03-Track208-Artificial Intelligence_Application in the Hospital_its Technology and Benefits.pdf 
 Download file: 20191111-03-Track209-Reliance The future of Medical device regulations.pdf  

Day-2 (12 Nov 2019):

 Download file: 20191112-01-General Overview on Cybersecurity trends around the Globe.pdf   
 Download file: 20191112-02-DITTA Activities in Cybersecurity and Update on IMDRF Work Item on Cybersecurity.pdf   
 Download file: 20191112-03-AHWP recent work on UDI_China NMPA Final UDI Rules for Medical Device.pdf    
 Download file: 20191112-04-Saudi Arabia UDI Rules for Medical Devices and Implementation Experience.pdf    
 Download file: 20191112-05-Chinese Taipei Experience in Implementation of UDI.pdf    
 Download file: 20191112-06-Global Medical Device Nomenclature GMDN_its Structure and its Applications in UDI and Electronic Health Records.pdf    
 Download file: 20191112-07-Key Updates on ISO13485_2016 Quality Management System for Medical Devices.pdf     
 Download file: 20191112-08-Implementation of Risk Based Approach in a Manufacturer to Meet ISO13485_2016.pdf     

Day-3 (13 Nov 2019):

 Download file: 20191113-01-AHWP Strategic Planning Towards Harmonisation.pdf   

 Download file: 20191113-02-AHWP WG Updates.pdf   

Day-4 (14 Nov 2019):

 Download file: 20191114-01-AHWP Overall Status Report01.pdf   
 Download file: 20191114-02-AHWP Overall Status Report02.pdf   
 Download file: 20191114-03-AHWPTC Overall Status Report.pdf   
 Download file: 20191114-04-IMDRF Member Country Harmonization Efforts_MDSAP.pdf   
 Download file: 20191114-05-IMDRF Member Country Harmonization Efforts_International Regulatory Cooperations.pdf   
 Download file: 20191114-06-IMDRF Status Update.pdf   
 Download file: 20191114-07-International Organizations Updates_APEC.pdf   
 Download file: 20191114-08-International Organizations Updates_ASEAN.pdf   
 Download file: 20191114-09-International Organizations Updates_African Medical Devices forum_former PAHWP.pdf   
 Download file: 20191114-10-International Organizations Updates_WHO Prequalification of in vitro diagnostics.pdf   
 Download file: 20191114-11-International Organizations Updates_WHO Medicines and Health Products Department.pdf   
 Download file: 20191114-12-AHWP Liaison Member Updates_APACMed.pdf   
 Download file: 20191114-13-AHWP Liaison Member Updates_DITTA.pdf   
 Download file: 20191114-14-AHWP Liaison Member Updates_GS1.pdf   
 Download file: 20191114-15-AHWP Member Country or Region Updates_China.pdf   
 Download file: 20191114-16-AHWP Member Country or Region Updates_Saudi Arabia.pdf   
 Download file: 20191114-17-AHWP Member Country or Region Updates_South Korea.pdf   
 Download file: 20191114-18-AHWP Member Country or Region Updates_Sultanate of Oman.pdf   
 Download file: 20191114-19-AHWP Member Country or Region Updates_Kyrgyz Republic.pdf   
 Download file: 20191114-20-AHWP Secretariat Updates_Secretariat Report.pdf   
 Download file: 20191114-21-Resolution and Endorsement.pdf