Page 78 - 2020Taiwan Food and Drug Administration Annual Report

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For the APEC Medical Devices Regulatory Science Center of Excellence Pilot Workshop, overall
satisfaction rate of trainees was 4.7 points (out of 5 points). A total of 41 trainees from the industry and
academic sectors of 8 different APEC member economies participated. After the completion of training,
trainees are able to assist in promoting the concept of medical device standards to APEC member
economies and help achieve the harmonization of regulations. This event also fully demonstrates

the regulatory capacity and capability of Taiwan while facilitating the establishment of cooperative
agreement and mutual recognition. In addition, TFDA actively participates in annual meetings and
working group meetings of IMDRF to help expand Taiwan’s global visibility and participation level
in important international organizations. And by conducting annual Joint Conference of Taiwan and
Japan on Medical Products Regulation, TFDA continues to promote interaction and understanding
of regulatory information between both sides, strengthen the collaboration between industry and
government, align with international standards, assist the industry to deploy into international markets,
and protect the public health and welfare. Years of case review and regulatory communication also
enhance the mutual trust between both sides. It is hoped that the product registration process may be

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Introduction of the Policy
Introduction of the Polic y
In response to the marketing globalization and enhancement of cosmetics management,
the “Cosmetic Hygiene and Safety Act” was announced by the President on May 2, 2018. The

date of implementation was also be set on July 1, 2019 by the Executive Yuan, except for the
relevant provisions of the information that shall be labeled on outer packaging or containers of
cosmetics will be implemented on July 1, 2021. This new law was stipulated in accordance with
the international regulations. It enables to strengthen the management of manufacturing facilities
and product full lifecycle as well as to build up a safe environment for high-quality cosmetics
and more comprehensively regulate and protect the rights of consumers.

Implementation Strategy
Implementation Strate gy
I. With the authorization of the parent law, TFDA announced 30 sub-regulations and orders
in 2019. TFDA has conducted about 162 education and training sessions and explanation

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