Page 57 - Taiwan Food and Drug Administration 2016 Annual Report

2016 ANNUAL
REPORT

Adverse Device
Reaction (ADR)
Reporting System Medical Device Safety
Monitoring
(with Periodic Safety Risk controls
Update Report, PSUR)
Active monitoring of Safety Amended packag inserts,
domestic and global restricted use, extended
surveillance monitoring duration,
medical device Re-evaluation of recalls, and product
safety alerts risk analysis withdrawals

Quality Part II - Key Administrative Results Medical Devices Management
surveillance
Defective Medical Device Post-market product Risk communication
Reporting System quality surveillance Risk communication
program Educational training,
awareness promotion,
Manufacturer audits and dissemination of
and joint audits information
Active monitoring of domestic
and global medical device
quality alerts

Figure 2-4-5 Post-market risk control mechanism of medical devices

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 2015, a total of 375 adverse reactions, 3,453 defective medical devices, 178 adverse events
in clinical trials, and 138 periodic safety update reports were uploaded to the Post-market
Quality Management System for Food, Drugs, and Cosmetics. These cases have underwent
data normalization as well as subsequent analysis and evaluation.

b. In 2015, a total of 1,936 domestic and global safety alerts were actively monitored, including
715 product alerts and 1,221 recall noti?cations. TFDA selected a total of 136 medical device
user safety messages concerning the domestic public, and translated them into summaries for
announcement.
(2) Joining the Global Vigilance Report Exchange System

The TFDA is a member of the Safety Alert Dissemination System (SADS) of the Asian
Harmonization Working Party (AHWP), which allows access to safety alerts and recalls that are
announced internationally. In 2015, a total of 1,416 messages were received. After evaluation,
it was revealed that 510 of these messages were related to Taiwan, whereupon noti?cations
were immediately released to the relevant businesses to initiate response measures.

(3) Improving ADR and Defective Product Reporting for Medical Devices
In addition to organizing continuous awareness programs and seminars to better motivate
medical institutions, manufacturers, and members of the public to report adverse reactions
and defective products, TFDA also established a program in 2015 to support seed hospitals in
establishing internal ADR reporting mechanisms. Personnel relevant to the noti?cation process
underwent training to improve the number and quality of ADR reports. The number of ADR
reports rose from 30 in 2009 to 375 in 2015, while the number of defective product reports rose
from 157 to 3,453 (Figure 2-4-6).
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