Page 67 - 2021 Taiwan Food and Drug Administration Annual Report
P. 67
to establish a comprehensive management Section 2
system that takes the properties of medical
GHYLFHV LQWR FRQVLGHUDWLRQ VXFK DV WKH UH- Expanded the International
SDLU DQG PDLQWHQDQFH RI PHGLFDO GHYLFHV Exchanges and
UHVWULFWLRQV RI VDOHV DQG VXSSO\ W\SHV HOHF- Collaboration on Medical
tronic registration and listing systems for Device Regulations
VRPH ORZ ULVN SURGXFWV LVVXDQFH RI OLFHQVH
ZLWK ÀH[LEOH YDOLGLW\ PHGLFDO GHYLFH FOLQLFDO Introduction of the Policy
WULDOV VDIHW\ PRQLWRULQJ RI PHGLFDO GHYLFHV
and proactive reporting. As international reg- TFDA has been committed to promoting
ulations have been taken into consideration international cooperation on medical devices
GXULQJ WKH GUDIWLQJ SURFHVV WKH Medical De- over the years and actively participating in
vices Act can reduce regulatory barriers do- international organizations to strive for host-
PHVWLFV ¿UPV RIWHQ IDFH LQ WKH LQWHUQDWLRQDO LQJ LQWHUQDWLRQDO FRQIHUHQFHV DQG DFWLYLWLHV
market. The new law can also provide con- to enhance Taiwan’s international partici-
sumers with better protection when they use SDWLRQ DQG LQÀXHQFH DV ZHOO DV WR FUHDWH DQ
PHGLFDO GHYLFHV $W WKH VDPH WLPH WKH $FW internationalized regulatory environment for
also facilitates the development of the med- PHGLFDO GHYLFHV ,Q WKH LPSOHPHQWD-
ical devices industry and enhances Taiwan’s tion priorities include applying to the APEC
competitiveness in the international market. RHSC to become a formal Regulatory Sci-
ence Training Center of Excellence (CoE)
II. Speeded up market approval of IRU PHGLFDO GHYLFHV SDUWLFLSDWLQJ LQ ,0'5)
domestic smart medical devices UHJXODWRU\ D൵DLUV SURPRWLQJ WKH IXO¿OOPHQW
of the cooperation framework between Tai-
FAQ of Smart Medical Devices can serve wan and Japan on medical products regula-
as a reference for firms engaging in the re- WLRQ DQG VWUHQJWKHQLQJ WKH UHJXODWRU\ FRP-
search and development of smart medical de- munication on medical products with the EU
vices. The Technical Guidance for Premarket and ASEAN countries.
Application can be used as a reference when
¿UPV DUH DSSO\LQJ IRU PDUNHW DSSURYDO DV LW Implementation Strategy
is used as the evaluation criteria for inspec-
tion and registration. By providing consulta- I. Became an APEC RHSC Regu-
WLRQ DQG WUDLQLQJ 7)'$ KDV LVVXHG SHUPLWV latory Science Training Center
to firms whose smart medical devices with of Excellence for medical devic-
DUWL¿FLDO LQWHOOLJHQFH ZLOO EH ODXQFKHG VRRQ es
In light of the “2019 APEC Medical
Devices Regulatory Science Center of Ex-
FHOOHQFH 3LORW :RUNVKRS´ KHOG LQ WKDW
65
