Page 75 - 2020Taiwan Food and Drug Administration Annual Report

II. Improving the management of smart medical devices to facilitate the
development of the industry
“Guidance for Industry: Cybersecurity for Networked Medical Devices” was drafted after
consolidating guidance and standards of advanced countries and international organizations on
cybersecurity of networked medical devices. The Guidance announced on December 15, 2019.
For medical device manufacturers, the Guidance provides key points related to cybersecurity for
product design, research and development, application of registration and market approval, and
post-market considerations. To improve manufacturers’ understanding of regulations governing

smart medical devices, TFDA invited international experts and organized four information
meetings on management regulations governing smart medical devices and pre-market review,
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devices in Taiwan and provided advice on various issues related to registration and market
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After the “Medical Devices Act” takes effect in Taiwan, it is expected that the Act can

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have better access to medical devices. In other words, citizens in Taiwan can use medical devices
that meet international standards and the Act opens a new chapter for management of medical
devices in Taiwan. TFDA announced the “Guidance for Industry: Cybersecurity for Networked
Medical Devices” to ensure cybersecurity of medical devices. In addition, by improving laws
and regulations, speeding up pre-market review, providing consultation and training of talents,
at present, two domestically manufactured innovative computer-assisted detection software are
now on the market.

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