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
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