Page 78 - 2023 Taiwan Food and Drug Administration Annual Report
P. 78
2023 Taiwan Food and
Drug Administration
Annual Report
Tip station ▍ Introduction of the Policy
Global Harmonization Working In light of growing emerging
Party (GHWP) technologies and the quick changes in
Founded in 1996, GHWP is an standards and regulations concerning medical
important voluntary organization devices internationally, TFDA is devoted to
in the world for the harmonization the promotion of international collaboration
of international medical device on medical devices, proactively taking part
r e g u l a t i o n s a n d C h i n e s e Ta i p e i in international organizations, and seeking
is one of the founding members. opportunities to hold international conferences
Having been elected as the Chair and events in order to maximize international
of Working Group 2 since 2012 and publicity and impacts and to help boost the
leading a total of 50 members from international competitive advantages of local
20 countries or regions, Chinese medical device manufacturers.
Taipei actively participate in GHWP-
related activities and works jointly to ▍ Implementation Strategy
harmonize pre-market regulations for
in vitro diagnostic (IVD) devices. Over I. Continued effort in
the years, a total of 15 IVD guidance promoting harmonization of
documents have been produced and international medical device
endorsed at the GHWP Meetings. regulations as an APEC
Since 2015, under the leadership of RHSC Regulatory Science
Chinese Taipei, Working group 2 has Training Center of Excellence
collaborated regularly with the World for Medical Devices
Health Organization (WHO) and
provided technical comments on 10 TFDA became a formal APEC RHSC
IVD documents. The results of which Regulatory Science Training Center of
have been recognized by countries Excellence for Medical Devices in 2020 and
globally. has been holding related workshops endorsed
by the APEC Regulatory Harmonization
76 Steering Committee (RHSC). The “2022
TFDA Medical Devices Regulatory Science
Center of Excellence Workshop” was held
from August 26 through September 11, 2022
(Figure 5-1) through video conferencing and
