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earned enthusiastic participation of attend- 7HFKQLFDO &RPPLWWHH 7& 7)'$ KDV SDU-
HHV IURP PDQ\ FRXQWULHV 7)'$ DSSOLHG WR ticipated in important meetings of the AHWP
the RHSC to become a formal Regulatory and held regular work group discussion
Science Training Center of Excellence. The meetings.
application was endorsed by the RHSC in a
WHOHFRQIHUHQFH RQ -XQH 7KH ³ III. Actively participated in the
APEC Medical Devices Regulatory Science IMDRF Principles of In Vitro Di-
&HQWHU RI ([FHOOHQFH :RUNVKRS´ ZDV KHOG agnostic (IVD) Medical Devices
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(Figure 5) in the forms of online courses and
meetings to share principles and experience The International Medical Device Reg-
for evaluating medical device safety and ulators Forum (IMDRF) is a voluntary in-
effectiveness with international standards. ternational organization consisted of global
7)'$ DOVR DUUDQJHG NH\QRWH VSHHFKHV medical device regulatory agencies. As a
JURXS GLVFXVVLRQV FDVH VWXGLHV DQG UHOHYDQW representative of the Asian Harmonization
courses and activities. :RUNLQJ 3DUW\ $+:3 7)'$ EHFDPH D
member of the IMDRF Principles of IVD
II. Led the activities of the AHWP Medical Devices Classification Working
in vitro diagnostic medical de- Group to participate in discussion meetings
vice work group of the guidance on principles of IVD classi-
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The Asian Harmonization Working Par- 6HSWHPEHU DQG 2FWREHU DQG
ty (AHWP) is currently one of the world’s 'HFHPEHU 7KH JXLGDQFH KDV EHHQ
most important voluntary organizations for approved by the IMDRF Management Com-
the harmonization of international medical PLWWHH DQG ZDV DQQRXQFHG RQ )HEUXDU\
device regulations. As the Chair of In Vitro 2021.
Diagnostic Medical Device Work Group
(WG2-Premarket: IVDD) of the AHWP IV. Held international conferences
on medical device regulations
Figure5 2020 APEC Medical Devices Regulatory Science Center of Excellence Workshop
66
