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AHWP/GHWP TC Leaders (Virtual) Meeting

Past Events
2020-10-13

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.

 

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