Page 74 - 2023 Taiwan Food and Drug Administration Annual Report

2023 Taiwan Food and
Drug Administration
Annual Report
international regulations of medical devices
and digitalization of applications, submissions, improve review and submission quality and
and reviews. In addition, many electronic
technology and IT companies have started to
conduct R&D of medical devices, but they
usually have insufficient knowledge about
medical device laws and regulations and face
challenges like lacking experience in clinical
practice and communication which results
in delays in launching products. In light of
this and to promote the development of the
domestic medical device sector, TFDA has
continued to make efforts to optimize laws and
regulations governing medical devices and
improve mechanisms to provide assistance and
support.
▍ Implementation Strategy
TFDA has compiled and analyzed
regulations management governing medical
devices or relevant guidances released
by developed countries and international
organizations. At the same time, TFDA has
also collected feedback on the implementation
of the Medical Devices Act from all parties
in Taiwan and adjusted applicable measures
under the Medical Device Act to reflect the
development and current status of the medical
device industry. TFDA has also prepared and
announced managerial or review guidances
related to medical devices. To improve
the efficiency of digital management, the
e-submission system for applications of
various medical devices was set up in phases.
At the same time, the digital review and
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archiving features have been optimized to
efficiency. In addition, the consultation and
counseling mechanism has been improved to
optimize the implementation efficiency and
effectiveness of the Intelligent Medical Device
Project Office; to provide matchmaking
service between the industry and hospitals;
to accelerate the development of innovative
medical devices.
▍ Achievements and Benefits
I. Enforcement of the Medical
Devices Act
TFDA implemented risk classification
for management. Statistics as of the end of
2022 showed that a total of 3,323 medical
devices had completed the procedures online
to be listed as Class 1 medical devices and 383
of the registered businesses had completed
the annual declaration procedures between
October and December. This approach
has helped strengthen the autonomous
management and accountability of
manufacturers and built a management system
that is internationally harmonized. Meanwhile,
the Medical Device Act also allows medical
device designers to be considered as medical
device dealers. At present, 10 academic,
research, and legal entities have successfully
obtained business permits as medical device
manufacturers, including National Cheng
Kung University, National Yang Ming Chiao
Tung University, and Industrial Technology