Page 80 - 2021 Taiwan Food and Drug Administration Annual Report

Section 2 Centers for Disease Control and the Ministry
of Economic Affairs. TFDA also surveyed
Management of Medical the manufacturing and import status of
Devices Related to PDQXIDFWXUHUV HVWDEOLVKHG SRLQWV RI FRQWDFW
Pandemic Control ZLWK PDQXIDFWXUHUV DQG KHOG PHHWLQJV WR
discuss alternative solutions.
Introduction of the Policy
II. Fast lane entry service to ac-
$W WKH VWDUW RI WKH &29,' SDQGHPLF celerate the market approval
FRXQWULHV IRXJKW IRU PHGLFDO VXSSOLHV ZKLFK of medical devices required for
resulted in an imbalance between supply and prevention of outbreaks
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XHV LW LV YLWDO IRU 7)'$ WR KDYH D FOHDU SLF- ,Q DFFRUGDQFH ZLWK 6XESDUDJUDSK 3DUD-
ture of available medical devices in Taiwan; graph 1 of Article 48-2 of the “Pharmaceutical
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the supply and demand of such medical de- made available to accelerate the application
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distribution of medical devices. At the same cases. TFDA has actively provided firms
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the market approval of medical devices relat- applications to manufacture medical devices
HG WR WKH FRQWURO RI RXWEUHDNV VR DV WR HQVXUH that could help to control the outbreaks as
WKH TXDOLW\ VDIHW\ DQG VXSSO\ RI PHGLFDO GH- special cases or apply for permits. A special
vices required for the control of outbreaks. hotline and a taskforce have been established
to provide consultation regarding regulations.
Implementation Strategy TFDA has also simplified the procedures by
(1) simplifying the documents required for
I. Took stock of permit license application for manufacturing as special cas-
information of medical devices es; (2) simplifying the quality management
required for the control of out- system information submitted by the manu-
breaks facturers; (3) announcing references used to
review and test medical devices manufactured
,Q WKH HDUO\ SKDVH RI WKH SDQGHPLF as special cases; (4) priority review conducted
TFDA quickly compiled the list of medical by assigned specialists. All these measures are
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of outbreaks as well as information of their ical devices needed to control the outbreaks
permit licenses. These medical devices RI &29,' ,Q DGGLWLRQ WR UHVSRQG WR WKH
LQFOXGH PHGLFDO PDVNV 1 JHQHUDO increasing demand for emergency COVID-19
PHGLFDO DQG VXUJLFDO PDVN LVRODWLRQ WHVWLQJ 7)'$ SUHSDUHG 6$56 &R9 VWDQGDUG
JRZQV IXOO ERG\ SURWHFWLYH VXLWV IRUHKHDG and respiratory related virus panel for the qual-
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