Page 18 - 2023 Taiwan Food and Drug Administration Annual Report
P. 18
2023 Taiwan Food and
Drug Administration
Annual Report
Section 5 technological medical and health devices, the
medical device industry has become one of
Overview of the most promising biotechnology industries
Medical Devices in Taiwan. In response to the booming
and Cosmetics development of the domestic medical device
Management industry, TFDA has established a full product
life-cycle management system for medical
I. Medical devices management devices (Figure 1-7) covering various aspects,
framework including internationalization of regulatory
management, production quality control, pre-
Following technological advancement market inspections, post-market surveillance,
and facing increasing demand for and distribution practice of medical device
Product design/ Pre-clinical Clinical trial Application Production Post-market
Prototype Testing for Marketing
development Approval
Classification of Good Laboratory Good Clinical Pre-market control Post-market surveillance
medical devices Practice (GLP) for Practice (GCP)
Nonclinical Labo-
and risks
ratory Studies
Review of clinical Registration
Trial protocol (Approval/Listing)
(TFDA/IRB)
Production Source Control Medical device advisory committee
Manufacturer Quality Management System (QMS) ADR & defective product
reporting
General / Case-Specific Consultation
Safety surveillance & alert
IRB：Institutional Review Board collection
ADR：Adverse Drug/Device Reaction
UDI：Unique Device Identification Good Distribution Practice
(GDP)
Tracking Management
and UDI
Consumer health education
and awareness
Figure 1-7 Total Product Life Cycle management system for medical devices
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