Page 81 - 2021 Taiwan Food and Drug Administration Annual Report
P. 81
ity control of molecular diagnostic reagents facilitate research and development in
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WKHU SURPRWLQJ WKH GRPHVWLF LQGXVWU\¶V H൵RUWV as public and private sectors to promote the
in pandemic control. development of the industry.
III. Strengthened quality manage- $FKLHYHPHQWV DQG %HQH¿WV
ment and safety management
of medical masks I. Ensured the supply of medical
devices for epidemic control
TFDA announced the amendments to the
“Regulations for the Inspection and Examina- (I) As TFDA has sped up the issuance of
tion of Imported Medicaments ´ 6WDUWLQJ IURP market approval permits for medical
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as one of the items to go through border in- our statistics showed that from February
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or importing a large volume of non-medical SHUPLWV IRU LVRODWLRQ JRZQV SHUPLWV
masks will need to pass on-site inspections. for forehead thermometers and 5 permits
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that Shall Be Indicated on the Labels of Flat domestic demand for medical supplies to
Medical Masks´ UHTXLULQJ ¿UPV WR HQVXUH WKDW ¿JKW WKH SDQGHPLF
IODW PHGLFDO PDVNV VKRXOG KDYH ³0'´ DQG
³0DGH LQ 7DLZDQ´ VWDPSHG RQ WKH PDVNV VWDUW- (II) Meetings to discuss alternative solutions
LQJ IURP 6HSWHPEHU and other response measures to get a
clear picture of the supply and demand
IV. Established a sound environ- of medical devices required for epidemic
ment for the development of FRQWURO ZKLFK LQFOXGHV UHSRUWLQJ FRQWURO
the medical devices industry and distribution of medical devices
for control of outbreaks to ensure that the sufficient supply of
medical devices in Taiwan.
To ensure that the capacity for research
and development and manufacturing of II. Enhanced the R&D and manu-
medical devices for epidemic prevention facturing capacity of domestic
accumulated during the COVID-19 medical devices
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special consultation for manufacturers who , :LWK IDVW ODQH HQWU\ VHUYLFH LQLWLDWHG
have obtained permission to manufacture IURP )HEUXDU\ WR 'HFHPEHU
medical devices as a special case to assist TFDA has approved 76 applications for
VXFK ¿UPV WR REWDLQ OLFHQVHV WR PDQXIDFWXUH manufacturing of medical devices as
medical devices. TFDA will continue to VSHFLDO FDVHV LQFOXGLQJ DSSOLFDWLRQV
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