Page 117 - 2021 Taiwan Food and Drug Administration Annual Report

Date of Name
announcement
Advance notice of the draft of the
“Regulations of Medical Device
Tracking Management”
September Advance notice of the drafts of “Medical
24 Devices That Shall Establish and
Maintain Sources and Flow Data”
and Product Items That Shall Report
Sources and Flow Data”
Advance notice of the draft of
“Regulations Governing the Sale Items
and Compliance Matters of Medical
Devices for Distance Sales”
Advance notice of the draft of the
“Regulations for Reporting Serious
Adverse Events of Medical Devices”
October 8
Advance notice of the draft of “the
Regulations for Management of
Medical Device Safety Surveillance”
October 15 Formulated the “Categorization and
classification of medical device ‘O.
3800 motorized vehicle for medical
purposes”, and ‘O. 3860 powered
wheelchair’ and the required labeling”,
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October 29 Advance notice of the draft of the
“Requirements Related to the
Exemption from Labeling Date of
Manufacture and the Period of Validity
or Shelf-life on the Labels, Instructions in accordance with Article 33 of the Medical
or Packaging of Medical Devices”
November 3 Established “the Guidance For
Enterovirus RNA Nucleic Acid
Amplification Test Reagents” and the
“Guidance For Toxoplasma gondii,
Rubella virus, Cytomegalovirus
Serological Reagents”
Important content
Established the regulations governing how
medical device firms and medical institutions
shall create and store the information on
sources and flows of medical devices,
including the method of storage, expiration
year, declaration and other matters to be
followed.
After conducting risk assessment, TFDA
specified medical devices items that need
to establish and maintain sources and flow
data. Among the aforementioned items, those
with higher risks must complete declaration
procedures on the platform established by the
central competent authority.
Specified the sales items and compliance
matters of medical devices for distance sales
in accordance with Article 18 of the Medical
Devices Act.
Established the regulations to govern the unit to
be notified, reporting method, reporting period
and reporting content for serious adverse events
of medical devices so as to ensure the safety of
the general public using medical devices.
Established the regulations to govern the
medical device safety surveillance data and
reports, submission of such data, deadline,
content, format, restrictions and maintenance
of data collection, surveillance period,
evaluation and other relevant matters.
Specified that for such products, the vehicle
body should be labeled with the medical
device license number. If the products have
been approved to have the characteristics of
a front-facing seat on a motorized vehicle, the
packaging, labels and user manuals should
clearly show “The product has passed the front
impact test required for motor vehicles with a
front-facing seat” for the general public to identity
legal products and to protect the priority right of
the disabled.
Established the rules on medical devices that are
exempted from labeling date of manufacture and
the period of validity or shelf-life on the labels,
instructions or packaging of medical devices
Devices Act.
Businesses can use the guidance as a reference
for research and development of products and
registration and market approval; Inspectors can
also use the guidance as a reference to ensure
the safety and effectiveness of the products in
the market.
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