Page 80 - 2023 Taiwan Food and Drug Administration Annual Report
P. 80
2023 Taiwan Food and
Drug Administration
Annual Report
IV. Organization of workshops harmonization of regulations. This event fully
for exchange on demonstrates the regulatory capacity and
international medical device review capability of Taiwan.
regulations
II. Spearheading GHWP in vitro
The 2022 Conference on International diagnostic medical device
Medical Device Regulations took place working group related events
online from November 7 to December 2,
2022. Government officials from Indonesia, For GHWP TC WG2, which is led by
Malaysia, Saudi Arabia, Tanzania, Thailand, Chinese Taipei, there are 15 global guidance
and Australia were invited to share their documents relevant to in vitro diagnostic
regulations governing medical devices. medical devices so far that have been endorsed
Regulatory experts from the EU and Singapore at the GHWP Meetings. The accomplishments
were also invited to share the post-market are well received internationally. The WG2
regulation of medical devices in the EU and hosted a member meeting on August 24 (taking
the regulatory policy on AI/ML medical place both physically and online). Members
devices. from the WG1 and WG3 were invited to
take part in discussions about revising the
▍ Achievements and Benefits draft on “Categorisation of Changes to a
Registered Medical Device” to strengthen the
I. Holding the 2022 TFDA communication between Taiwan and New
Medical Devices Regulatory Southbound or other member countries and to
Science Center of Excellence increase Taiwan’s visibility and involvement
Workshop in international organizations.
TFDA Medical Devices Regulatory III. Bonding audit resources
Science Center of Excellence Workshop was in Taiwan and Europe to
held in 2022. The overall satisfaction among benefit supply of medical
participants was 4.5 (out of 5). A total of devices in both Taiwan and
53 trainees from the industry and academic Europe
sectors of 13 different economies were in
attendance. After the completion of training, In response to the revision of EU medical
trainees were able to assist in promoting device regulations and to effect of Taiwan’s
the concept of medical device standards to “Medical Device Act” on May 1, 2021, the
APEC member economies and to help achieve third generation of Taiwan-Europe Technical
Cooperation Program (TCP III) is being
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