Page 74 - 2020Taiwan Food and Drug Administration Annual Report

Implementation Strate gy
Implementation Strategy

I. Completed the legislation of the “Medical Devices Act”
After years of effort, the Legislative Yuan passed the third reading of the “Medical Devices
Act” on December 13, 2019 and the Act with 85 articles were announced on January 15, 2020
under the Presidential Decree. The Act allows medical device “designers” to apply for their
own license and establishes a mechanism to give those who develop new medical devices more
flexibility with license issuance, to encourage all industries to invest in technology research
and development. Moreover, the Act has deregulated some low-risk Class I medical devices, so
registration and approval of such low-risk medical devices can be complete via online listing,

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repairers are also classified as medical device dealers. Medical device firms that sell medical
devices with certain level of risk are required to provide information regarding the place of
origin and flow of products; medical devices firms are also required to manage the storage
conditions, transportation and personnel who transport the products, and to follow Guidance for
Good Distribution Practice for medical devices. See Figure 5-1 for the key points of the “Medical
Devices Act.”

Facilitated the launch of innovative medical Encouraged businesses to invest in R&D
devices to meet the demand of our citizens and make medical devices with Taiwan Brand.

Implemented risk management and
simplified the pre-marketing review
Simplified the clinical trial procedures for process for low-risk Class I medical devices
medical devices and sped up the R&D
processes of domestic medical devices
Better management of new sales
models and facilitated diverse
commercial development
Improved the management of
medical devices and enhanced
consumer protection
Established a good distribution and
management system to ensure the
quality of products in circulation on the market
Established flow management
of medical devices for better Enhancing business autonomous
management of place of origin and use management and implementing
supervision on post-market products

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