AHWP/GHWP TC Leaders (Virtual) Meeting
Chaired by Mr. Ali M. Al-Dalaan, AHWP/GHWP Chairman, moderated by Bryan So, Executive Secretary General of AHWP/GHWP, supported by AHWP Secretariat c/o Hong Kong Medical and Healthcare Device Industries Association. The 2020 AHWP/GHWP TC Leaders (Virtual) Meeting was held on 13th October 2020 from 1 pm to 6:30pm (HKT) successfully with the aim to study and recommend harmonization of medical device regulation in Asian/Globle.
The Meeting was kicked off by welcome speeches by Dr. Hisham bin Saad Aljadhey, the CEO of Saudi Food & Drug Authority, Mr. Ali M. Al-Dalaan, AHWP/GHWP Chairman and Mr. Gao Guobiao, AHWP/GHWP Vice Chairman.
Guest speakers Ms. Melissa Torres, Associate Director for International Affairs of U.S. FDA, Ms. Adriana Elazquez Berumen, Biomedical Clinical Engineer of WHO and Ms. Wong Woei Jiuang, Assistant Group Director of IMDRF, shared updates on their organizations and related Covid-19 activities.
There are nine Work Groups (WG) listed as below to present their Work Group updates and WG2, WG5 and WG6 with Covid-19 updates.
WG1 - Pre-Market Submission and CSDT
WG2 - IVDD
WG3 - Pre-Market Software as a Medical Device
WG4 - Post-Market
WG5 - Clinical Evidence for Performance and Safety
WG6 - Quality Management System: Audit & Assessment
WG7 - Quality Management System: Operation & Implementation
WG8 - Standards
WG9 - UDI & Nomenclature
Towards the closing of the meeting, there were two Closed Door Meetings for Technical Committee Advisors and AHWP/GHWP & Technical Committee Leaders respectively.