Page 74 - Taiwan Food and Drug Administration 2016 Annual Report

Taiwan Food and Drug Adminstration

3. Medical Device Safety Risk Assessments
(1) Risk Identi?cation and Information Collection

a. Monitoring of Medical Device Alerts
In 2015, TFDA continued to collect medical device alert information from official health agency
websites of various countries around the world. Such information was then used accordingly to
initiate mechanisms of inquiry in Taiwan. In 2015, relevant inquiries of 1,936 alerts were completed.
b. Reporting of Medical Device Adverse Events
In 2015, data standardization, analysis, and assessment were completed for 375 and 614 adverse
reaction reports from Taiwan and other countries respectively, as well as 3,453 reports on defective
products, 178 reports on adverse events during clinical trials, and 138 periodic safety update
reports.
(2) Risk Assessment Mechanism and Control

a. Medical Device Safety Evaluation
For medical devices with adverse event reports, when their monitoring period is over or if other safety
concerns arise, TFDA will further collect relevant safety information in Taiwan and other countries for
the Medical Device Safety Assessment Consultation Committee to conduct post-market evaluations
of clinical usage safety, effectiveness, and risks of medical devices, and will formulate risk control
measures (such as revisions to package inserts, conduct unannounced factory audits, or extend
the safety monitoring period of medical devices). A total of three Safety Assessment Consultation
Committee meetings were held in 2015.
b. Quality Surveys of Medical Devices

Risk rating is carried out according to the extent of hazards described in defective medical devices
reports. License holders are notified every quarter to conduct root cause analysis for quality
nonconformities and submit preventive and corrective measures according to the requirements
prescribed in the medical device GMP.
c. Risk Control Measures for Medical Devices

According to the results of the aforementioned safety evaluations and quality surveys, seven medical
devices in 2015 were required to be prioritized for on-site audits or GMP/QSD reviews, four were
required to revise package inserts, and seven were required to provide supplementary information.

(3) Training of Risk Assessment Professionals
a. In 2015, causes of medical device defects reported in the past were reviewed by TFDA, and
six seminars on adverse device reaction (ADR) reporting system for medical institutions,
companies, and members of the public regarding six major topics (disposables, cardiovascular
devices, assistive devices, medical cosmetology, periodic safety monitoring of medical devices,
and regulations related to medical devices) were held. The purpose of these seminars was to
enhance proper understanding of safe use and responsibility of sending reports in order to
improve reporting rates.

b. In 2015, projects were carried out to provide assistance to seed hospitals in establishing ADR
reporting mechanisms within hospitals in order to raise awareness of the safe use of medical
devices amongst medical practitioners and improve the reporting rates and quality of ADRs
within medical institutions.

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