Page 81 - 2019食藥署年報(英文版)

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To strengthen the domestic medical device and cosmetics management system and meet
the international standards, TFDA had drafted the "Medical Device Act", which was passed
in the Legislative Yuan on 2018/12/14 through parliamentary group consultation. Meanwhile,
TFDA also started to amend the "Statute for Control of Cosmetics Hygiene" in 2011, which was
renamed as "Cosmetic Hygiene and Safety Act" on 2018/5/2, to strengthen the quality and safety
management of medical device and cosmetics in our country. Furthermore, TFDA had made an

important breakthrough in international cooperation on medical device management. In 2008,
Taiwan and Japan signed the "Memorandum of Cooperation on the Medical Devices Factory
Inspection and Reporting" and implemented the system of on-site inspection in overseas medical
device manufacturers.
Moreover, in order to improve the quality of laboratory developed tests and services for
precision medicine molecular testing in the precision medicine molecular testing Laboratory,
the "Guidance on Laboratory Developed Tests and Services (LDTS) for Precision Medicine

Molecular Testing" was announced in 2018 to enhance protection of the health and safety of the
citizens and speed up the development of precision medical industry.

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The regulations for medical device management in Taiwan were originally stipulated
in the Pharmaceutical Affairs Act. As the characteristics of medical device management and
the relevant business model in the industry are clearly different from those of pharmaceutical
products, in order to strengthen the domestic medical device management system and make it in
line with the international standards, TFDA has initiated the assessment on the institution of a
legal framework for the medical devices, and developed the "Draft Medical Device Act" that met
the needs in international and domestic environments.

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