About GHWP

Global Harmonization Working Party (GHWP) is a non-profit organization. Its goals are to study and recommend ways to harmonize medical device regulations and to work in coordination with international stakeholders such as WHO, OECD, International Medical Devices Regulators Forum (IMDRF), and Global Alliances such as : GS1, Asia Pacific Medical Technology Association (APACMed), Global Medical Devices Nomenclature Agency (GMDN Agency) , Global Medical Technology Alliance (GMTA), Global Diagnostic Imaging, Healthcare IT, and Radiation Therapy Trade Association (DITTA) and Inter-American Coalition for Regulatory Convergence for the Medical Technology Sector (IACRC),aiming at establishing harmonized requirements, procedures and standards.

GHWP is a group of experts from the medical device regulatory authorities and the medical device industry, consisting of 32 countries/regions such as Saudi Arabia, China , USA, Hong Kong, South Korea, Singapore, Malaysia and Indonesia and chaired by Mr. Ali Al-Dalaan (Saudi Arabia –SFDA) , the vice chairs are Mr. GAO Guobiao (China-NMPA) and Ms. Quan Tran (Singapore-Industry).

The organization includes 9 scientific and technical work groups which are premarket requirements – General Medical Devices, premarket requirements –IVDD, premarket requirements: Software as a medical device, postmarket, clinical Evidence for performance and Safety , quality management system: audit and assessment , quality Management System: Operation and Implementation, standards and UDI.


For more information about the GHWP, please visit the webpage: (www.ghwp.info)