Page 86 - 2019食藥署年報(英文版)

on the signing of the Taiwan-Japan MOC. Since Taiwan-Japan MOC signed, there are more than
ten Japanese manufacturers and one Taiwanese manufacturer have applied through this method.
In the future, the Japanese inspection agencies will inform the TFDA for on-site auditing in
Taiwan, which will assist the medical device manufacturers of both parties to speed up the
document review process, facilitate the outstanding medical devices to enter the market, and
provide a quality medical environment for the citizens in the country.

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7KH 2I¿FH RI WKH 3UHVLGHQW RI¿FLDOO\ HQDFWHG WKH Cosmetic Hygiene and Safety Act" on
May 2, 2018. This Act was formerly known as the "Statute for Control of Cosmetic Hygiene."
The main purpose of law amendment is to respond to the development of the globalization
market, reinforce the source and circulation management of cosmetics, and construct a high-

quality cosmetics environment for the citizen in the nation. In this amended version, the
implementation date is set to be on July 1, 2019, except for the relevant provisions of the
information that shall be labeled on outer packaging or containers of cosmetics is set to be on
July 1, 2021. The key points of the Cosmetic Hygiene and Safety Act are shown in Figure 5-3.

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1. In response to the development of the globalization market and the trend of regulation

harmonisation, the new act was stipulated in accordance with international regulations
and included the toothpaste and mouthwash in the cosmetics management, to further
ensure the safety of consumers. On the basis of the announced schedule by the Ministry
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site must comply with the Good Manufacturing Practice (GMP) as a replacement of
the current registration system of medicated cosmetics (it is called the specific purpose
cosmetics in the new act). It will speed up the process for the product entering the market,
provide online product information to consumers, ensure the production quality of

cosmetics, and ensure the health and safety of cosmetics. In addition, the new regulations
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obligations of businesses, and inspection on the imported cosmetics at borders, to ensure
consumer’s rights via the comprehensive regulations. TFDA has conducted about 120

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