Page 36 - 2017食品藥物管理署年報(英文版)

2017 Taiwan Food and Drug Administration Annual Report

medical devices with pre-clinical test guidances were commissioned to
Center for Drug Evaluation (CDE) for reviews to enhance submission
quality and efficiency.
c. Promulgate four medical devices which industries can use affidavit
letters as the pre-clinical test documents for registration application,
including the “infrared ear thermometer”, to simplify the registration

application procedures.

(4) Talent cultivation and establishment of excellent medical device clinical trial
environment
A. Recommend two talents from academic/research field and professionals in pre-
clinical tests to go to the US for advance training. Additionally, TFDA selects
two surgeons from orthopedics and thoracic surgery and recommends them to

go to the US for learning the most updated medical technology, i.e. 3D printing.
In the meanwhile, TFDA promotes clinical trials involving medical devices for
academic purposes in Taiwan.
B. TFDA reimbursed the clinical trial centers in two teaching hospitals to help them
develop specialized clinical trial centers in order to improve the quality and
efficiency of clinical trials in Taiwan.

(5) Comprehensive medical devices and cosmetics consultation/counseling networks

A. TFDA successfully facilitates 19 domestic medical devices approved for
marketing, 12 applications entering clinical trials and 5 academic/research
outcomes technically transferring into industry. One of which is the first
domestic “blood glucose monitoring system” collaborating with smart phone
and the marketing of the first global cervical cancer screening kit “carcinogen
methylation detection kit”.
B. Select 8 advanced seed regulators to serve as pilots to help pass on medical device

laws, regulations and knowledge.
C. Establish medical devices and cosmetics counseling helpline. In 2016, the
helpline served up to 19,193 times, of which 9,019 for cosmetics-related queries.
Additionally, the helpline also served 5 businesses for appointment reservations
in Hsinchu Biomedical Science Park.
D. Host two cosmetics GMP internal audition training courses at North, Central and
South District respectively to strengthen self-management capacities of cosmetic
industries. A total of 668 people participated in the courses.

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