The Food and Drug Administration of Taiwan (TFDA) hosted Global Harmonization Working Party (GHWP) Technical Committee (TC) joint working group (WG) meeting in its own conference rooms in Taipei, Taiwan on 1-3 August 2023. The meeting was held among WG1 (Pre-Market Submission and CSDT), WG2 (Pre-market: IVDD), and WG3 (Pre-market: Software as a Medical Device), and TFDA welcomed all the 27 participants, especially the 16 guests travelling from Kingdom of Saudi Arabia, Singapore, Japan, South Korea and Hong Kong. The agenda focused on the joint work items of the three WGs, but also provided a chance for each WG to discuss its own affairs in person by allotting half a day for parallel sessions. The event marked the first post-pandemic face-to-face meeting among the three WGs, who made substantial progress in the work items through productive discussions.

 

     GHWP is an international voluntary organization aiming at global convergence and harmonization of medical device regulations. Toward the goal, it promotes an agile and fit-for purpose regulatory model for medical devices through a series of guidance documents, developed by its TC working groups. However, as related technologies develop rapidly and regulations under different jurisdictions are updated from time to time, GHWP guidance documents need to be revised to reflect the current regulatory landscape. The two joint work items addressed in this meeting are both revising existing guidance documents, originally prepared collaboratively by the three attending WGs. The first revisited document is titled “Principles of Regulatory Requirements for Electronic Instructions for Use (eIFU),” whose content was enriched and references updated in this revision. The other work item is to develop a document regarding the management of changes made to a registered medical device, by merging existing related GHWP documents. In the meeting, attendees from the three WGs had lively discussions and contributed their respective expertise to the revising work, producing fruitful outcomes when the meeting adjourned.

 

     As a member of GHWP since its establishment, Taiwan has been dedicating to harmonization in medical device regulations by actively participating the organization’s activities. Taiwan FDA had been the Chair of WG2 since 2012 and was elected as Chair of WG3 in 2023, and has received worldwide positive recognition for all the efforts devoted. Taking the leading role and the initiative, Taiwan FDA hosted this first physical joint WG meeting to declare that the operation of the organization had recovered from the challenges posed by the pandemic. It also thanks all the honorable participants for attending the meeting and for their valuable opinions, which made the meeting itself and its outcomes possible. Taiwan FDA will continue to contribute to promoting medical device regulation harmonization, such that new medical technologies can be promptly introduced with emphases on the safety and performance, to benefit possible users worldwide.