2015 Annual Report
Section 4 Medical Device Safety Management
To establish a comprehensive safety surveillance mechanism and maintain post-market safety
surveillance of medical devices, TFDA has established an adverse device reaction (ADR) reporting
system, and been actively monitoring domestic and global medical device safety alerts, strengthening
distribution management of marketed goods, and promoting awareness of relevant regulations and
policies (Figure 5-4). The use of effective quality reporting systems allows for quick feedback, helps
regulatory agencies to exercise effective medical device safety management, and may propose
corrective and preventive measures to achieve a positive feedback cycle for excellent quality.
Policies and Outcomes
1. Strengthening Post-market Safety Monitoring of Medical Devices
(1) Active Monitoring of Domestic and Global Medical Device Safety Alerts
a. In 2014, a total of 1,454 safety alerts were received from the Safety Alert Dissemination System
(SADS) of the Asian Harmonization Working Party (AHWP).
b. In 2014, Taiwan's ADR Reporting System received a total of 1,401 cases of defective medical devices
and 209 cases of adverse device reactions.
c. In 2014, a total of 3,058 domestic and global safety alerts were actively monitored. These include
1,293 product advisories and 1,765 recall notifications. TFDA flagged 93 of these alerts as potentially
affecting the domestic public, and translated them into summaries for announcement.
(2) Joining the Global Vigilance Report Exchange System
TFDA is a member of the National Competent Authority exchange program (NCAR) of the
International Medical Device Regulators Forum (IMDRF) and receives recall notifications and safety
of domestic and
device safety alerts
Medical Device Safety
Monitoring (with Periodic
Safety Update Reports, PSUR)
audit, joint audit
recalls, and product
and awareness work
and dissemination of
Post-market risk control mechanism of medical devices