Page 66 - 2021 Taiwan Food and Drug Administration Annual Report
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ward-looking management regulations and public for daily health management will not
strengthened our provision of legal consul- be governed as medical devices. The revi-
WDWLRQ DQG JXLGDQFH KRSLQJ WR DFFHOHUDWH WKH sion should help accelerate domestic firms’
launch of smart medical device products. research and development in manufacturing
health promotion products. As more and
Implementation Strategy more information and communication tech-
nology (ICT) companies have invested in the
I. Enforcement of the Medical De- UHVHDUFK DQG GHYHORSPHQW RI DUWL¿FLDO LQWHO-
vices Act OLJHQFH PHGLFDO GHYLFHV 7)'$ LVVXHG ³)$4
RI 6PDUW 0HGLFDO 'HYLFHV´ RQ 0D\
The “Medical Devices Act´ KDV D WRWDO RI WR DQVZHU IUHTXHQWO\ DVNHG TXHVWLRQV
85 articles. To facilitate the implementation UHJDUGLQJ WKH DSSOLFDWLRQ LQVSHFWLRQ UHJLV-
RI WKH QHZ ODZ 7)'$ WRRN LQWR DFFRXQW LQ- WUDWLRQ DQG PDUNHW DSSURYDO SURFHVV RI VPDUW
ternational management standards and the PHGLFDO GHYLFHV ,Q DGGLWLRQ ³$UWLILFLDO ,Q-
current domestic situation to establish 22 telligent/Machine Learning-Based Software
supporting sub-regulations and issue advance DV D 0HGLFDO 'HYLFH $, 0/ %DVHG 6D0' ´
QRWLFHV RI UHOHYDQW GUDIWV LQFOXGLQJ ³Regula- ZDV DQQRXQFHG RQ 6HSWHPEHU WR
WLRQV *RYHUQLQJ &DWHJRUL]DWLRQ DQG &ODVVL¿- serve as a reference for manufacturers when
cation of Medical Device, Regulations Gov- they develop products. The guidelines also
erning Issuance of Medical Device License, OLVW LQIRUPDWLRQ DQG GRFXPHQWV ¿UPV QHHG WR
Listing and Annual Declaration, Regula- prepare when they apply for inspection and
tions of Medical Device Tracking Manage- UHJLVWUDWLRQ RI WKHLU SURGXFWV 6R IDU 7)'$
ment,” and “Regulations for Management has provided consultation to 9 manufacturers
of Medical Devices Technicians ´ WR EXLOG D of smart medical devices in Taiwan on the
complete lifecycle management system for design of clinical trials and information for
PHGLFDO GHYLFHV %X൵HU WLPH DQG VXSSRUWLQJ market approval. This once again demon-
PHDVXUHV DUH DOVR SXW LQ SODFH WR JLYH ¿UPV strates that TFDA pays close attention to the
a reasonable period of time to adopt and to development of smart medical devices.
minimize the impact to the industry.
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II. Improved management of
smart medical devices I. Built an independent and
comprehensive medical de-
TFDA made an announcement on De- vices management system
FHPEHU UHJDUGLQJ WKH DPHQGPHQW
of “Guidance for Medical Software Classi- After the “Medical Devices Act” was
ILFDWLRQ ´ 7KH UHYLVLRQ VWDWHV WKDW PHGLFDO SDVVHG WKH PDQDJHPHQW RI PHGLFDO GHYLFHV
VRIWZDUH XVHG IRU KHDUW UDWH PHDVXUHPHQW is removed from the “3KDUPDFHXWLFDO $ৼDLUV
blood oxygen products (including wearable Act ´ 7KH QHZ ODZ HQDEOHV WKH JRYHUQPHQW
GHYLFHV DQG RWKHU SURGXFWV XVHG E\ WKH
64
