Page 81 - 2020Taiwan Food and Drug Administration Annual Report

the creative promotion of cosmetics promotion as well as take into consideration of the
development in the industry; The consumers might give incentive reward for reporting
violations of cosmetics or their business operators; the regulations are stipulated to safeguard
the health of the citizens in Taiwan and protect the rights and interests of consumers which
will be reviewed from time to time for improvement in the future.

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Introduction of the Policy
Introduction of the Polic y
Due to the rapid development of modern and new medical devices and cosmetics, there is
an urgent need to establish the analytical technology for quality management of various products,
to expand the testing items in cosmetics and to develop or optimize the analytical methods for
management of domestic products. In addition, we interact and cooperate with countries across
the world in order to keep pace with the current global development and to catch up with the
future trend in analytical technology. The following were included in the “Cosmetic Hygiene and

Safety Act” announced on May 2, 2018, the central competent authority may entrust cosmetics
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entrusted institutions to enhance business efficiency and ensure the quality and credibility of
random inspection.

Implementation Strate
Implementation Strategy
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I. Established testing and verification methods for innovative intelligent
medical devices

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modules and wearable blood oxygen detection systems in 2019, with the collection of relevant
testing technology and international standards for wearable measurement devices such as
electrocardiography (ECG) and blood oxygen detection system and we referred to the IEC 60601-
2-25 and IEC 60601-2-27 standards to establish a electrocardiography functional test method.
In addition, we established the functional test methods for blood oxygen sensors by referring to
various standards such as FDA Guidance-Mobile Medical Application, ISO 80601-2-61, IEC
60825-1 and the results were published on the Industrial Economics & Knowledge Center (IEK)
to strengthen the effectiveness of dissemination.

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