Page 114 - 2021 Taiwan Food and Drug Administration Annual Report

Table 8 Addendum/amendment to the regulations and standards related to medical
devices management in 2020
Date of Name
announcement
January 15 The President promulgated the
“Medical Devices Act”.
January 31 Amended “The template for Chinese
package insert of medical devices
intended for home use Soft contact
lenses”
March 31 Advance notice of the draft of the
“Regulations Governing Medical
Device Quality Management System”
April 6 Advance notice of the draft of the
“Regulations Governing Accreditation
and Outsourced Accreditation
Management of Medical Devices
Institutions”
April 13 Announced the “Guidelines for
Evaluation of Human Factors/Usability
Engineering of Medical Devices”
April 20 Amended the preclinical testing
April 28 guidance for “soft contact lenses”
Announced the preclinical testing
guidance for “mechanical wheelchair
with electric power unit”
May 18 Advance notice of the draft of the
“Regulations for the Inspection of the the good distribution practice for medical
Good Distribution Practice for Medical devices, including inspection content,
Devices and Licensing of Distribution
License”
May 26 Advance notice of the draft of the
“Regulations of Medical Device Good
Distribution Practice”
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Important content
The management of medical devices is
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An independent law was established to govern
medical devices management and to ensure
that Taiwan’s medical devices management
follows international standards and meets
practical needs.
To e n s u r e t h a t t h e g e n e r a l p u b l i c c a n
understand how to use soft contact lenses
correctly by reading the package insert. The
template can also be used as a reference
for manufacturers when they draft package
inserts.
Established relevant regulations requiring
medical device manufacturers to establish
medical device quality management system,
hoping that manufacturers conform with
regulations governing medical device quality
management system.
To facilitate the accreditation and outsourced
accreditation of medical devices institutions;
to enhance the management of accreditation
institutions and outsourced accreditation
institutions.
Provide medical device manufacturers with
guidelines to evaluate human factors/usability
engineering of their products during the phase
of product design, research and development,
application for registration, and product launch.
The guidance can be used as a reference
when manufacturers are engaging in research
and development of similar products and
when they apply for registration and market
approval; Inspectors can also use the
guidance as a reference to ensure the safety
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Established the regulations for the inspection
inspection methods, conditions for approval,
review, issue, effective period, change,
cancellation or revocation and other matters
that should comply with good distribution
practice.
Established the “Regulations of Medical
Device Good Distribution Practice” to ensure
that medical devices meet the requirements
of the original manufacturer during storage,
transportation, and distribution processes, and
the integrity of the medical devices can be
maintained to ensure the safety of users.