Submitted by admin on Thu, 06/15/2023 - 18:09

GHWP has completed two-day Technical Committee (TC) Leaders Meeting in Shenzhen, China on 14th and 15th June 2023, the first physical meeting of the GHWP TC Leaders after COVID. The two-day meeting started with a half-day open workshop with attendance of over 350 stakeholders from the medical device industry. Experts from GHWP, including GHWP Vice-Chairs - Mr. Lupi Trilaksono from Indonesia and Ms. EunHee Cho from Korea, GHWP TC Co-Chair - Ms. Miang Tanakasemsub from Thailand, WG1 Chair – Dr. Seil Park from Korea, WG2 Chair – Mr. Tsai Wen Wei from Chinese Taipei, WG 3 Chair – Mr. Chien Chun Jen from Chinese Taipei, shared the topics on GHWP Strategic Framework towards 2026, achievements of GHWP TC and outlook for future work, industry participations in GHWP TC, innovative medical devices regulation policies, key points on pre-market requirements for IVD products and pre-market review requirements for Software as a Medical Device (SaMD).  


Dr. Xu Jinghe, GHWP Chair, delivered the welcome speech at the Opening of the GHWP TC Leaders Meeting, followed by the sharing of the work progress and work plans by Chairs and Co-Chairs of eight Working Groups, covering Premarket: medical device, Premarket: IVD, Premarket: Software as a medical device, Post-market, Clinical evidence for performance and safety,      Quality management system, Standards, UDI and nomenclature. To fulfil the fit-for-purpose regulatory objectives, there are common work items amongst all working groups with action plans on retention, revision or abolishment of the existing working group guidance documents. Amongst all the 40+ GHWP published guidance documents, 17 guidance documents would be abolished and the remaining documents would be either retained or revised. There are also 7 new guidance documents targeted to be endorsed during the GHWP 27th Annual Meeting and 27th GHWP TC Annual Meeting on 27-30 Nov 2023 in Shanghai, China.


During the two-day meeting, GHWP Leadership has also hold the Leadership Meeting in the morning of 14th June 2023, with discussions on the detail criteria and target candidates for the Strategic Advisory Board of GHWP, report on the preparation progress on the coming GHWP Annual Meeting, criteria for setting up of the capacity building training hubs, updates on the exploration of further collaborations with the IMDRF, as well as the exploration of setting up the GHWP Medical Device Innovation Forum in the coming CMEF Medical Equipment Fairs in China, to further promote the collaborations and communications between regulatory authority and the industry in medical device industry.


Apart from all the fruitful discussions on technical topics on medical device regulatory convergence, it was also confirmed by Dr. Abdullatif S. AlWatban, GHWP TC Chair, that the next GHWP TC Leaders Meeting would be held in June 2024 in Bali of Indonesia, to continue the momentum on promoting medical device regulatory harmonization through equal participations of the regulatory authority and the industry in GHWP, towards the ultimate goals on global harmonization of medical device regulatory requirements, to enable better accessibility and affordability of latest medical technologies, to benefit the patients and communities worldwide.


GHWP completed two-day TC Leaders Meeting in Shenzhen, China on 14-15 June 2023