Page 76 - 2020Taiwan Food and Drug Administration Annual Report

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Introduction of the Policy
Introduction of the Polic y

TFDA has been committed to promoting international cooperation on medical devices
over the years and actively participating in international organizations to strive for hosting
international conferences and activities, to enhance Taiwan's international participation and
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In 2019, the implementation priorities include applying for conducting a pilot workshop of the
Regulatory Science Training Center of Excellence (CoE) for medical devices, participating
in IMDRF regulatory affairs, promoting the fulfillment of the cooperation framework

between Taiwan and Japan on medical products regulation, and strengthening the regulatory
communication on medical products with ASEAN countries.

Implementation Strategy
Implementation Strate gy
I. Hold the APEC Medical Devices Regulatory Science Center of Excellence
Pilot Workshop
At the end of 2018, TFDA applied to APEC Life Sciences Innovation Forum’s Regulatory
Harmonization Steering Committee (APEC LSIF-RHSC) for conducting a pilot workshop

of the Regulatory Science Training Center of Excellence (CoE) for medical devices and the
application was approved by the RHSC on March 21, 2019. The “2019 APEC Medical Devices
Regulatory Science Center of Excellence Pilot Workshop” was held from October 22 through
24, 2019 (Figure 5-3), to share principles and experience for evaluating medical device safety
and effectiveness with international standards. TFDA also conducted activities such as keynote
speeches, group discussions, case studies, and factory visit.

II. Strive to join the IMDRF Working Group and continue to send staff to
participate in the annual meeting
The International Medical Device Regulators Forum (IMDRF) is a voluntary international
organization consisted of global medical device regulatory agencies. With the approval of
IMDRF Management Committee in June 2019 and as a representative of Asian Harmonization

Working Party (AHWP), TFDA became a member of the Principles of IVD Medical Devices
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TFDA also represented APEC to join IMDRF Management Committee meetings in March and
September of 2019 and reported the work progress of APEC during open forum.

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