Page 120 - 2020Taiwan Food and Drug Administration Annual Report

Table 8c Addendum/amendment to the regulations and standards related to medical
T able 8
devices management in 2019
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Announced the “([DPSOHV RI 3URSHU DQG This provide clear and specific basis
Improper Advertisement Wording of Class I for businesses to revise or edit their
+BOVBSZ Medical Devices” for 11 items advertisement wording for Class I medical
devices and to prevent unintentional violation
of laws and regulations.
Amendment to the “Fee-Charging Standards for Fees related to medical devices are
Registration and Market Approval and Cosmetic LQGHSHQGHQWO\ VSHFL¿HG LQ WKH “Fee-Charging
Advertisements of Medical Devices” Standards for Registration and Market
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Approval and Cosmetic Advertisements
of Medical Devices” This fee-charging
standards are effective on July 1, 2019.
Announced that “for medical devices that )RU PHGLFDO GHYLFHV WKDW UHTXLUH LQFOXVLRQ
UHTXLUH LQFOXVLRQ RI VSHFL¿HG WH[W LQ DFFRUGDQFH RI VSHFLILHG WH[W LQ DFFRUGDQFH ZLWK WKH
with the provisions of Administrative Regulations provisions of Administrative Regulations on
+VOF on Low Power Radio Waves Radiated Devices, Low Power Radio Waves Radiated Devices,
firms shall follow the regulations and do not ¿UPV VKDOO IROORZ WKH UHJXODWLRQV DQG GR QRW
need to submit application of registration and need to submit application of registration and
market approval to TFDA.” market approval to TFDA.
Announced the “([DPSOHV RI 3URSHU DQG This provide clear and specific basis
Improper Advertisement Wording of Class I for businesses to revise or edit their
+VMZ Medical Devices” for 10 items advertisement wording for Class I medical
devices and to prevent unintentional violation
of laws and regulations.

5HYLVH $QQH[HV IRU $UWLFOHV DQG RI Amended medical devices classification,
Regulations for Governing the Management of FDWHJRUL]DWLRQ LWHP QDPHV DQG LGHQWL¿FDWLRQ
+VMZ Medical Device to clarify identification, use and align
with international management model for
businesses to follow.
Announced the “2019 List of Medical Devices Announced that 1,051 international medical
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medical device manufacturers can choose
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to follow these standards when they develop
and test medical devices to ensure the safety
and effectiveness of products in the market.
Announced the pre-clinical testing guidance Business can use the guidance as a
4FQUFNCFS for “tooth shade resin material (F.3690)” and reference for research and development
“vascular graft prostheses (E.3450)” of product and registration and market
approval; Inspectors can also use the
Modified the pre-clinical testing guidance for guidance as a reference to ensure the safety
“infrared lamp (therapy apparatus),” “R[LPHWHU ” and effectiveness of the products in the
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“electronic sphygmomanometers,” and market.
“electrocardiograph”
Announced the “Guidance for Manufacturers: For medical device manufacturers, the
Cybersecurity for Networked Medical Devices” guidance provides key points related to
cybersecurity for product design, research
and development, application of registration
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and market approval and post-market
considerations, to ensure that medical
devices can meet the cybersecurity
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