Submitted by admin on Fri, 12/01/2023 - 03:11

On November 29, 2023, the 27th Global Harmonization Working Party (GHWP) Technical Committee (TC) Meeting grandly kicked off in Shanghai, China. Dr. Xu Jinghe, GHWP Chair and Deputy Commissioner of the National Medical Products Administration (NMPA, China), attended the meeting and delivered a speech.


As pointed out by Dr. Xu Jinghe, GHWP (Global Harmonization Working Party) is a big family that unites all forces and facilitates consensus. GHWP TC is responsible for organizing the formulation of GHWP guidance documents, which is the key to fostering global medical device regulatory convergence, harmonization and reliance. GHWP TC should actively formulate GHWP guidance documents around cutting-edge innovative technologies and best regulatory practices, and constantly optimize the working mechanism for drafting, solicitation of public opinions, revision, and approval of GHWP guidance documents. Moreover, GHWP TC should also further encourage the participation of GHWP members, improve the quality of GHWP guidance documents, and continuously strengthen cooperation with relevant international organizations.


GHWP TC Meeting is an important part of the GHWP Annual Meeting. At the GHWP TC Meeting, the work progress of all Work Groups (WGs) was reported in the fields of pre-market/post-market medical device regulation, clinical evaluation, quality management system, standards, unique device identifier (UDI), and nomenclature. Besides, an in-depth discussion was also delivered on such topics as the formulation and revision of GHWP guidance documents and new work programs. More than GHWP TC leadership, Chairs, Co-chairs, secretaries, and TC advisers of all WGs and more than 600 attendees from 25 countries and regions were present at the GHWP TC Meeting.