Global Harmonization Working Party (GHWP)

GHWP is a group of experts from the medical device regulatory authorities and the medical device industry. Its goals are to study and recommend ways to harmonize medical device regulations globally. GHWP works in coordination with the IMDRF.

GHWP has the following technical committees:

Working group 1Premarket of medical devices
Working group 2Premarket (IVD)
Working group 3Software as MD
Working group 4Post market
Working group 5Clinical evidence of performance and safety
Working group 6Quality Management System: Audit & Implementation
Working group 7Quality Management System: Operation & Implementation
Working group 8Standards
Working group 9UDI & nomenclate

TMDA has been a member in the GHWP since 2014 and has representatives in working group 1 and working group 2. The following benefits have been experienced:

  • Capacity building
  • Information sharing
  • Collaborations