Page 115 - 2021 Taiwan Food and Drug Administration Annual Report

Date of Name
announcement
Announced the preclinical testing
June 12 guidance for “D5630 nebulizer”, “F6070
UV activator for polymerization” and
June 15 “M1570 ophthalmoscope”
Announced the preclinical testing
guidance for “Dental Bone Grafting
Material/Resorbable Calcium Salt Bone
Void Filler Device Containing Materials
Derived from Animal Sources” and
“Polymethylmethacrylate (PMMA)
Bone Cement”
Advance notice of the draft of the
“Regulations Governing the Inspection
of the Medical Device Quality
Management System and the Issuance
of the Manufacturing License”
June 17
Advance notice of the draft of the
“Regulations on Good Clinical Practice
for Medical Devices”
July 6 Advance notice of the draft of the
“Regulations Governing Incentive
Rewards for Research and
Development of Innovative Medical
Devices Technology”
Advance notice of the draft of the
“Regulations Governing Designation or
Commission of Medical Devices Test”
July 7
Amended the “Regulations for the
Inspection and Examination of
Imported Medicaments”
July 17 Announced the “Guidance on In Vitro
Companion Diagnostic Devices”
Advance notice of the draft of the Specify the qualifications, job descriptions,
July 20 “Regulations for Management of continuing education and other matters related
Medical Devices Technicians”
Important content
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
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Govern the application for the inspection
of medical device manufacturers’ quality
management systems and matters related to
the registration particulars, issue and change
of manufacturing licenses.
Established the management scope, standard
operating regulations, application procedures,
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of interest, information disclosure, supervision
and management, inspection, the content of
the informed consent form, and other matters
for compliance with clinical practice for medical
devices.
Established the qualifications for awards,
review procedures and other related
matters in order to encourage agencies and
personnel in Taiwan to engage in the research
and development of medical devices and
innovative technologies.
Designate a subordinate agency (or
institution) or commission a relevant agency
(or institution), legal entity, or organization to
conduct all or part of the inspection of medical
devices, and formulate relevant regulations
governing designation, commission and
related matters.
Medical masks are included in the items
subject to border inspections for complete
flow control and to ensure the safety and
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the public.
Businesses can use the guidance as a
reference for research and development of
product and registration and market approval;
Inspectors can also use the guidance
as a reference to ensure the safety and
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to medical device technicians.
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