Page 77 - 2023 Taiwan Food and Drug Administration Annual Report
P. 77
5Improving Management of Medical
Devices and Cosmetics
distribution activities after releasing from have been issued following QMS inspections,
the manufacturer to the dealers, TFDA has including 1,331 domestic manufacturers
established the “Regulations of Medical and 5,197 importers, and a total of 63 valid
Device Good Distribution Practice” (GDP). distribution licenses have been issued
The dealers with the license among the following GDP inspections. Through the
announced list of the 45 items in force on manufacturing licenses and distribution
18 March 2021 and those authorized for licenses, TFDA could ensure the quality and
import shall comply with GDP and obtain safety of medical devices.
a distribution license since 1 May 2023 to
ensure that people access to good quality, safe, II. Transparency in the review
and effective medical devices. of quality management
system
III. Promotion of e-application
for management over Through the application platform, TFDA
quality of medical devices effectively keeps track of the dynamics of
businesses to assist in the early market launch
TFDA created the “Medical Device of medical device products in Taiwan and to
Quality Management Application Platform” achieve a triple-win situation for the general
that became officially operative on January public, the industry, and the management of
1, 2022; medical device businesses can now medical devices. Throughout 2022, inspections
apply for inspections, check the status of were completed for 1,419 devices applied for
the application process quickly, and receive through the platform.
the latest information about announcements
and communications through the application Section 3
platform.
Maximized
▍ Achievements and Benefits International
Exchange and
I. Ensured Conformity Collaboration on
fulfillment of QMS and medical Device
GDP in the manufacturing Regulations
and distribution of medical
devices 75
As of the end of 2022, a total of 6,528
valid medical device manufacturing licenses
