Submitted by admin on Fri, 12/01/2023 - 02:24

At 9:00 a.m. (Beijing time) on November 27, 2023, the 27th GHWP Annual Meeting and TC Meeting was grandly kicked off in Shanghai, China. The Global Harmonization Working Party (GHWP) was established in 1997, the predecessor of which was the Asian Harmonization Working Party (AHWP). GHWP is an international organization with long history and wide membership. With the joint participation of regulatory authorities and industry representatives, GHWP is engaged in promoting global medical device regulatory convergence, harmonization and reliance through the concerted efforts of regulatory authorities and industry representatives. GHWP is committed to enhancing the regulatory capacity building of GHWP member countries and regions, striving to contribute more wisdom and strength to the quality improvement of global medical devices and the protection of global public health. This GHWP Annual Meeting was hosted by the GHWP secretariat. Dr. Xu Jinghe, GHWP Chair and Deputy Commissioner of China Medical Products Administration (NMPA) delivered opening remarks and welcomed nearly 700 attendees from 25 countries and regions around the world who were present at the meeting, including experts in the medical device industry, counterparts from regulatory authorities, and representatives of medical device enterprises.


The meeting from November 27 to 28 focused on GHWP capacity building, with the theme of "Opportunities and Challenges in Regulation of Innovative Medical Devices". Under this theme, 6 topics were set. Senior experts from regulatory authorities and industry representatives were cordially invited to introduce medical device regulations, share best practices, and join panel discussions around such new cutting-edge technologies as artificial intelligence (AI), Software as a Medical Device (SaMD), 3D printing, and next generation sequencing (NGS).


Innovation is the most highlighted key word of this annual meeting. Jia Jianxiong from China NMPA, Miyasaka Tomoyuki from the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan, Seil Park from the Ministry of Food and Drug Safety (MFDS) of Republic of Korea, Lailing Liew from Health Sciences Authority (HSA) of Singapore, and Razan Asaly from the Saudi Food and Drug Authority (SFDA) of Kingdom of Saudi Arabia introduced the their regulatory policies on encouraging medical device innovation around the topic of regulatory pathways for innovative medical devices.


Cooperation is the most important spirit of this annual meeting. In the panel discussion on the topic of medical device adverse event monitoring and vigilance and change management, Kitty Mao from GE HealthCare as the moderator, organized an in-depth panel discussion on good vigilance practices for innovative medical devices, attended by Gao Pei from Peking University, Salbiah Yaakop from the Ministry of Health (MOH) of Malaysia, Kusakabe Tetsuya from PMDA of Japan, and Shang Wei from Allergan Aesthetics. This topic aims at exploring opportunities for cooperation between regulatory authorities and industry representatives in medical device adverse event monitoring.


This annual meeting is timely focuses on hot issues, with special topics such as new cutting-edge technologies medical devices and regulatory practices, regulatory pathways for innovative medical devices, regulatory tools to foster innovation, risk management of innovative medical devices, unique device identifier (UDI) application practices, and digital regulation of medical devices, etc. 


The 27th GHWP Annual Meeting has provided an opportunity for global regulatory authorities and industry representatives to exchange ideas, share experiences, and develop cooperation, thus jointly boosting the innovation and progress of the medical device industry.