Page 82 - 2018食藥署年報(英文版)

Outcomes and Benefits

1. In 2017, 8 innovative medical devices had been approved and 4 clinical trials of medical
devices had been activated with the assistance from the program of “Principles for Medical
Device Consultation.” The highlighted outcomes includes a Hepatitis B viral load test kit,
a Hepatitis D total antibody reagent, a dengue fever NS1 antigen quick test reagent, and an

implanted spinal stimulator. The results are considered impressive.
2. In 2017, up to 20,017 regulatory consultations had been provided through CDE’s hotline. In
addition, several consultation services had been reserved and provided to manufactures in the
biomedical science parks to promote innovation of medical devices.
3. With the joint efforts from the Administration, CDE, and 47 seeds trained in 2017 (the completed
list of seeds has been published on our website), the scope of regulatory consultation service has
been successfully expanded to cover local communities. This regulatory consultation network

aims to help businesses to establish regulatory compliance as early as possible.

Section 3 Preparation of Guidelines for 3D-Printing
of Medical Devices

Origin of Policy

Many manufacturers, the academic research institutes, and the medical community in our
country have devoted to the R&D and manufacturing of 3D-printed medical devices. In order
to define related device management scope and regulatory requirements and to also ensure that
such products are safe and effective, the Administration referred to management regulations in
other countries around the globe and the development status of related industries in our country in
2016 and 2017 to stipulate the “Guidelines for Additive Manufacturing (3D Printing) of Medical

Devices (Draft)” and officially promulgate it accordingly on January 12, 2018.

Implementation Measures

1. 3D-printing is a new technology applied in the manufacturing of medical devices, and it has
a wide scope of application. Thus, regulatory data available for reference in the international
realm is quite limited. As such, while the draft was being prepared, one international
symposium, three expert meetings (where experts from the industry, government, research
institutes, and medical community and related units of the Administration were invited), five
visits to domestic and international medical device manufacturing/3D-printing facilities, three
internal meetings, and one external and internal briefing session, were respectively organized

to extensively collect opinions from all parties, and eventually, the “Guidelines for Additive
Manufacturing (3D Printing) of Medical Devices” were successfully completed.

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