Page 97 - 2017食品藥物管理署年報(英文版)

2017 Taiwan Food and Drug Administration Annual Report Chapter 6. Early Warning, Monitoring and Risk Management

(1) Medical devices and cosmetics risk recognition and data collection
A. Actively monitor alerts
(A) In 2016, TFDA actively collect 2,044 national and international medical
device safety alerts and selected 80 alerts which closely relevant to fellow
citizen’s health for further translate and promulgate.
(B) In 2016, TFDA monitored 192 updated national and international cosmetics
recall and safety alerts, passed them to health bureaus and cosmetics
associations through e-mails, and issued 165 food must-know alerts to the
consumers.

B. ADR
(A) Through “Post-market Quality Management System for Food, Medicinal
products, and Cosmetics”, in 2016, TFDA received 427 medical devices
ADR and 3,429 defective medical devices, which had been standardized
and evaluated subsequently.
(B) A total of 58 cosmetics adverse events, of which 15 cases of adverse
reactions and 43 cases of defective produsts were received in 2016, all have

been informed to local health bureaus for related matters or companies to
submit investigation reports. TFDA also continues follow-ups.

C. Risk evaluation mechanisms and control of medical devices and cosmetics
(A) Convene 3 medical devices safety advisory board meetings in 2016 to
evaluate and review 17 applications and promulgate dermal implants within
the identification scope of “I.0007 Hyaluronic acid implants” on December
2, 2016 for overall safety surveillance. By the end of December 31, 2016, 2
major categories of medical devices that are within the identification scope,

including “drug eluting cardiac stents”, shall be completely enrolled for
safety surveillance.
(B) For defective medical devices reports, TFDA classifies based on risk and
hazardous levels and informs companies with permits to investigate the
causes of quality abnormalities of medical devices in accordance with GMP
regulations. In 2016, among 35 medical devices required for prioritized
factory inspections or GMP/QSD document reviews, 3 of them were asked

to amend package inserts, 5 of them were asked to prolong surveillance

95