Page 65 - 2021 Taiwan Food and Drug Administration Annual Report
P. 65
Ch5 Improved Management of
Medical Devices and Cosmetics
The President promulgated the “Medical FDO 6RIWZDUH ´ ,Q PXOWLSOH LQVSHFWLRQ
Devices AcW´ RQ -DQXDU\ $IWHUZDUGV methods have been added to inspect and test
WR IDFLOLWDWH WKH HQIRUFHPHQW RI WKH QHZ ODZ medical devices and cosmetics and to enhance
TFDA has established relevant sub-regu- Taiwan’s inspection standards. TFDA also pro-
ODWLRQV UXOHV DQG RUGHUV WR HQVXUH WKDW WKH motes the listing and registration of precision
“Medical Devices Act” and all relevant laws medicine molecular diagnostics laboratories
are harmonized with international regulations. and issues technical guidelines on molecular
$W WKH VDPH WLPH 7)'$ KDV EHHQ YHU\ DFWLYH testing to accelerate the development of the
to participate in various events organized by precision medicine industry.
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cific Economic Cooperation (APEC) and Section 1
the International Medical Device Regulators
Forum (IMDRF). TFDA also strived for op- Enhanced the Medical
portunities to host international conferences Devices Act and Relevant
and activities to enhance Taiwan’s internation- Regulations
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the “Cosmetic Hygiene and Safety Act” was Introduction of the Policy
officially implemented to accelerate the reg-
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SURGXFW LQIRUPDWLRQ ILOHV DQG HQVXULQJ WKDW es Act´ SDVVHG WKH WKLUG UHDGLQJ DQG ZDV DS-
manufacturers comply with Regulations Gov- proved by the Legislative Yuan on December
erning Good Manufacturing Practices. The 7KH $FW ZDV SURPXOJDWHG RQ -DQ-
purpose is to build a safer environment that XDU\ E\ WKH 3UHVLGHQW 7R SURPRWH
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improve the management of intelligent med- VXSSRUWLQJ VXE UHJXODWLRQV UXOHV DQG RUGHUV
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Intelligent/Machine Learning-Based Software technology and information technology have
DV D 0HGLFDO 'HYLFH $, 0/ %DVHG 6D0' ´ engaged in the research and development of
and amended the “Reference Guidelines for smart medical devices. To further promote
Categorization and Classification of Medi- the development of smart medical devices in
7DLZDQ 7)'$ KDV ZRUNHG WR HVWDEOLVK IRU-
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