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