Page 77 - 2018食藥署年報(英文版)

Medical Devices and Cosmetics

05 Management Reforms

In light of the obvious differences between medical devices and drugs in terms of their
characteristics and industrial operation models, and in order for our laws and regulations
governing medical devices to comply with their international counterparts, the Administration
separated laws and regulations governing medical devices from the Pharmaceutical Affairs Law
and prepared the Draft Medical Devices Act. In addition, in order for the cosmetics management
system to comply with the international counterpart and to increase the competitive advantages
of Taiwan‘s cosmetics industry around the globe, proactive efforts have been made to amend the

Cosmetic Hygiene and Safety Act to maintain the hygiene and safety of cosmetics.
To expedite commencement of the clinical trial phase for innovative medical devices or to
shorten the time frame needed for marketing and accordingly boost competitive advantages of
Taiwan’s medical device industry around the globe, the Administration established the project
regulatory consultation and assistance mechanism and prepared the “Guidelines for Additive
Manufacturing (3D Printing) of Medical Devices.”

Section 1 Preparation of the Medical Devices Act

Origin of Policy

The requirements on the management of medical devices that are available in our country
can be found in the Pharmaceutical Affairs Act. In light of the obvious differences between
medical devices and drugs in terms of their characteristics and industrial operation models,
and to improve the management of medical devices for compliance with international laws and
regulations, the Medical Devices Act was planned separately to help normalize the domestic
medical device management system.

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