The 22nd GHWP Annual Meeting was successfully held in New Delhi, India, on 4-8 December 2017. Please find the presentation materials below: Download file 01 4Dec2017_Regulatory Updates from India 02 4Dec2017_Medical Devices & IVD's An Australian Updates 03 4Dec2017_Overview of IVD Regulations in Korea 04 4Dec2017_An overview of regulations of medical devices and IVDs in South Korea 05 4Dec2017_Regulatory Updates from Japan 06 4Dec2017_Regulatory Updates from Singapore 07 4Dec2017_Medical Device Single Audit Program (MDSAP) 08 4Dec2017_Adapting your ISO 13485 to the new Requirements 09 4Dec2017_Role of Technical Standards and updates on international technical standards 10 4Dec2017_Clinical Trial Environment-Australia 11 4Dec2017_Accessibility, Affordability of Medical Devices and Safeguards of Consumer Rights 12 4Dec2017_Access to Medical Devices for Universal Health Coverage and achievement of SDGs 13 4Dec2017_Accessibility Affordability of Medical Devices _South East Asia Regional perspective 14 5Dec2017_Clinical Investigations and Real World Evidence 15 5Dec2017_Preparatory steps to Medical Device Controls_ASEAN experience centring on AMDD elements 16 5Dec2017_Takes 2 to Tango CSDTEP and Standards 17 5Dec2017_AHWP Update_The Road to Harmonization 18 5Dec2017_Classification Rules for Medical Devices 19 5Dec2017_Objectives and Limitations_ In-Country Testing- Industry Perspective 20 5Dec2017_Objectives and limitations_ In-country Lab Testing 21 5Dec2017_CAB Role and Grouping _A balance between Regulatory Controls and Processes with the Economics of MD Industry 22 5Dec2017_Overview of Medical Device Clinical Investigation Regulations in Korea 23 5Dec2017_Clinical Investigation and evaluation for Medical Devices_ Regulator perspective 24 5Dec2017_GS1 Update and UDI Databases 25 6Dec2017_Challenges and issues to regulate an innovative Medical devices_ barriers and enablers to development 26 6Dec2017_Changing global regulatory environment_ opportunity and threat in industry_focused on premarket 27 6Dec2017_Medical Device Clinical Trial Landscape in APAC 28 6Dec2017_Post market Surveillance of Medical Device 29 6Dec2017_Pre market approval _ Essential Principles for safety quality and performance 30 6Dec2017_Use of Real World Evidence in Clinical and Regulatory Decision from Industry Experience 31 6Dec2017_Post Market Considerations for Digital Healthcare 32 6Dec2017_Unifying Efforts against Counterfeiting Medical Devices 33 6Dec2017_Advertisement & Labelling 34 6Dec2017_Benefits & Risks of Remote Monitoring_ Regulatory Considerations across Jurisdictions 35 6Dec2017_Considerations in Quality Management of 3D printed Medical Devices 36 6Dec2017_The Future of Global Evidence Generation_ Advancing the Role of Big Data in Innovation 37 07Dec2017_STG 38 07Dec2017_WG1 39 07Dec2017_WG2 40 07Dec2017_WG3 41 07Dec2017_WG4 42 07Dec2017_WG5 43 07Dec2017_WG6 44 07Dec2017_WG7 45 07Dec2017_WG8 46 Highlight of AHWP PB Training 47 08Dec2017_Updates by AHWP 48 08Dec2017_Updates by AHWPTC 49 08Dec2017_Regulatory Updates from China 50 08Dec2017_AHWP Liaison Member Updates by APACMed 51 08Dec2017_AHWP Liaison Member Updates by DITTA 52 08Dec2017_Endorsement of New Member Economy 53 08Dec2017_Secretariat Updates_Secretariat Report 54 08Dec2017_Secretariat Updates_Financial Report 55 08Dec2017_Resolution towards Endorsement 56 08Dec2017_Election of AHWP Leadership of 2018 - 2020
