Page 82 - 2021 Taiwan Food and Drug Administration Annual Report
P. 82
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medical masks and 1 application for small accelerate the implementation of the policy.
electrocardiogram system. The approval
encourages domestic firms to continue IV. Established a sound environ-
to conduct research and develop medical ment for the development of
devices. We have also approved 111 the medical devices industry
applications for importing medical devices for control of outbreaks
import as special cases for control of the
outbreaks in Taiwan. TFDA worked closely with companies
(II) TFDA prepared SARS-CoV-2 standard and research institutions who are interested
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and acquired the SNQ certification for GHYLFHV LQ 7DLZDQ WR LQYHVW LQ WKH 5 ' DQG
PHGLFDO SHULSKHUDO SURGXFWV LQ production of medical devices for control of
demonstrating the inspection capabilities RXWEUHDNV WXUQLQJ WKH FKDOOHQJH SRVHG E\
of Taiwan's national laboratories and the pandemic into an opportunity for Taiwan
the visibility and credibility of the WR DFFXPXODWH H[SHULHQFH WUDQVIRUP DQG
preparation of biological standard grow. The ultimate goals are for Taiwan’s
products. industry to acquire the ability to develop
and prepare key raw materials; to establish
III. Strengthened the quality man- a sound environment for the development
agement and safety manage- of medical devices for epidemic control;
ment of medical masks and to strengthen the production capacity of
Taiwan's biotechnology industry.
To strengthen the quality management
DQG VDIHW\ PDQDJHPHQW RI PHGLFDO PDVNV Section 3
TFDA has announced the amendments of
relevant regulations. Firms importing both Name-Based Mask
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importing a large volume of non-medical and Related Measures
masks will need to pass on-site inspections.
These measures are taken to ensure the safety Introduction of the Policy
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IURP WKH VRXUFH 0RUHRYHU GRPHVWLFDOO\ In the early phase of the COVID-19
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WR KDYH ³0'´ DQG ³0DGH LQ 7DLZDQ´ implemented a Name-Based Mask
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