Page 118 - 2021 Taiwan Food and Drug Administration Annual Report

Date of Name
announcement
Announced the “Guidance on
November 4 Registration and Market Approval
of Reprocessed Single-use Medical
Device”
Advance notice of the draft of the
“Medical Device Product Items That
Shall Obtain Marketing Authorization
by Means of Listing”
Advance notice of the draft of the
“Labels, Instructions or Packaging
of Specific Medical Devices Shall
Additionally State the Warnings and
Cautions”
Advance notice of the draft of “the
Requirements for Indicating the Unique WKH LQGLFDWLRQ RI 8QLTXH 'HYLFH ,GHQWL¿HU 8',
Device Identifier on Medical Device
Labels”
November 5 Announced that natural persons who
import medical devices subject to
border inspection for personal use
should fill in the special certificate for the Inspection and Examination of
code IF000000000001 for customer
clearance. The rule took effect on
November 18, 2020.
The obligatory inspection applicant
referred to in Subparagraph 4,
Article 2 of the “Regulations for
the Inspection and Examination
of Imported Medicaments” refer to
importers of medicaments. Therefore,
natural persons who import medical
devices for personal use do not need
to apply for inspection according to
the “Regulations for the Inspection
and Examination of Imported
Medicaments”.
November 6 Advance notice of the draft of “the
Regulations for Medical Device
Recalls”
Advance notice of the draft of the
“Designated Product Items for Medical
Device Safety Surveillance”
November Advance notice of the draft of
13 “Regulations for Approval of Specific
Medical Devices’ Manufacturing or
Importing as a Special Case”
116
Important content
The guidance can be used as a reference
for manufacturers or relevant agencies
reprocessing single-use medical devices and
applying for registration and market approval.
Inspectors can also use the guidance for
reference.
Specified what product items of medical
devices may obtain market approval by means
of listing in accordance with Paragraph 1,
Article 25 of the Medical Devices Act.
Mandatory requirements for specifically
medical devices to add warnings and cautions
of potential risk on product labels and package
inserts.
Established relevant regulations that require
on the single packaging or device body of
Classes II and III medical devices.
In accordance with Article 2 of the Regulations
Imported Medicaments, the obligatory
inspection applicants refer to medicaments
importers. Therefore, the obligatory inspection
applicant referred to in the Regulations
should not include a natural person. The
administrative rules are announced to interpret
the regulations and to provide a code for
exemption from inspection as a supporting
measure for customs clearance.
Specified which medical devices should be
recalled by medical device manufacturers and
importers, as well as the classification, recall
operations, treatments, and other matters to
be followed.
With the announcement of the draft of
“Regulations for Management of Medical
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should be included in the safety surveillance.
Specified the application conditions, review
procedures, approval criteria, supply and sale
restrictions, return shipment and other matters
to be complied with for medical devices
manufacturing or importing as a special case.