Page 73 - 2020Taiwan Food and Drug Administration Annual Report

Consummated Medical

05cDevices and Cosmetics
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Management

To improve Taiwan's medical devices and cosmetics management systems and to align

domestic laws and regulations with international regulations and standards, the “Medical Devices
Act” was drafted and the Act has been promulgating according to the Presidential Decree issued
on January 15, 2020. Moreover, as the “Cosmetic Hygiene and Safety Act” has been promulgate
according to the Presidential Decree issued on May 2, 2018, TFDA has completed promulgation
of 30 relevant regulations in 2019, marking the beginning of a new era for Taiwan's management
of cosmetics. In addition, through active participation in various international organizations,
including Asia-Pacific Economic Cooperation (APEC) and the International Medical Device
Regulators Forum (IMDRF), TFDA worked to enhance Taiwan's international visibility and
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In response to the rapid development of smart medical devices, TFDA announced the
“Guidance for Manufacturers: Cybersecurity for Networked Medical Devices” with new test and
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medical devices. In 2019, several different quality inspection methods on medical devices and
cosmetics were revised or added, to comprehensive improve the Taiwan's inspection standards.
TFDA also actively conducts the listing and registration management of precision medicine
molecular diagnostics laboratories to facilitate the development of precision medicine industry.

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Introduction of the Policy
Introduction of the Polic y
With diversifying development of global medical devices and diversified types of
products, businesses operation model, and classification management system are different
from the pharmaceutical industry; hence, to improve the management of medical devices in

Taiwan, it is necessary to stipulate a special medical devices management act to respond to
the demands in domestic market and to align with international standards. Moreover, in recent
years, with rapid development of smart medical devices with communications technology, it is
necessary to establish regulations to govern the management of smart medical devices that suit
Taiwan's conditions and help businesses overcome legal obstacles they faced during the product
development process and speed up the development process.

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