Page 76 - 2023 Taiwan Food and Drug Administration Annual Report
P. 76
2023 Taiwan Food and
Drug Administration
Annual Report
Device (AI/ML-based SaMD) for Class For the sake of ensuring management at
2 and 3 medical devices, and 76 projects the source and over the distribution of medical
received consultation and support from devices and to go with the “Medical Devices
the Office. In the end, 6 applications of Act,” which came into force on May 1, 2021,
domestically manufactured AI/ML-based TFDA reinforced the QMS and included GDP
SaMD successfully obtained market approval. in the management in an effort to normalize
The results were highly recognized by all management over the quality of medical
parties. To integrate information related to devices throughout their life cycle.
medical devices, the “Intelligent Medical
Device Information and Matchmaking ▍ Implementation Strategy
Platform” was established with 195 registered
members. On the platform, 29 authorities have I. Enhancement of medical
activated their membership have activated device QMS management
their membership to be matchmakers and have
served up to 280 thousand members already. TFDA has established the “Medical
In 2022, 5 matchmaking meetings were held Device Quality Management System
to facilitate the technical collaboration for Regulations” (QMS) to harmonize with the
7 medical device businesses, evaluation of latest international standard for medical
investment collaboration for 1 investment device quality management systems (ISO
team, and collaboration between 3 businesses 13485:2016). The manufacturers establish a
and hospitals happen in clinical fields. quality management system in accordance
with the regulations, so that all stages of a
Section 2 medical device are under the control of the
manufacturer’s quality management system,
Reinforced including design and development, production,
Management over storage, distribution, installation, service,
Manufacturing decommissioning, and disposal. Through QMS
Quality and compliance inspections, TFDA supervises
Distribution of manufacturers to enforce the implementation
Medical Devices of QMS, thus ensuring the quality and safety
of devices in the market.
▍ Introduction of the Policy
II. Promotion of GDP for
74 medical devices
To ensure that the quality of a medical
device is maintained throughout the
