Page 56 - 2017食品藥物管理署年報(英文版)

2017 Taiwan Food and Drug Administration Annual Report

5. Medical devices and cosmetics distribution management

(1) To ensure the product quality established by the original manufacturers can be
maintained during transportation and marketing period, TFDA promotes medical
devices distribution management since 2014 and promulgates “Medical Device
GDP” on June 18, 2015. Host 5 sessions of GDP training course in 2016, complete
counseling inspections in 30 medical device distributors. Additionally, include related
regulations in the draft of Act governing medical devices management advanced
promulgated on December 5, 2016. In the future, medical devices GDP will be

implemented in scheduled stages.
(2) To rapidly recognize medical devices on the market, quickly obtain product adverse
events report and ensure uniformity of barcode formats of medical devices, TFDA
announced “Medical Device UDI” on October 30, 2015 to provide businesses
qualified medical device UDI barcode format regulations that comply with
international standards and established the foundations of their automatic distribution
management system. In 2016, through the implementation of programs, TFDA
successfully introduced UDI into routine medical device inventory management in
patient’s surgical records of Division of Cardiovascular Surgery at Taipei Veterans

General Hospital.
(3) To plan for revising Statute for Control of Cosmetic Hygiene and establishing
“Cosmetic product notificaiton system”, TFDA encourages industries actively register
on the Notification Portal now. After the revision, TFDA will enforce industries to
register on the portal to control cosmetics on the market.
(4) The establishment of Cosmetic Product Notification Portal is completed in 2013
(Figure 4-3). To help industries

familiarize with the use and
operations of the notification
portal, TFDA organized 3
orientations and 25 training
courses in 2016. A total of 1,326
companies and 2,041 cosmetic
products were successfully
registered online.

Figure 4-3 Cosmetic products notification portal

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