Page 83 - 2018食藥署年報(英文版)

2. The Guidelines stipulates its scope of application and includes a list of product attributes
in respective parts of the 3D printing technology for management. In addition, special
considerations and related verifications and assessments are also covered with regard to the 3D

printing software work flow, product quality and manufacturing control, and finished product
testing, among others, for industrial reference.

Outcomes and Benefits

Management advice and principles are provided in the Guidelines to expedite review and
approval of the 3D-printed medical devices and introduction to the market as early as possible, to
create a high-quality industrial development environment, and to push Taiwan’s medical device
industry onto the world stage. This policy was highly recognized in various respects. So far, a
total of 3 permits have been issued for 3D-printed medical devices approved to enter the market,

including the dental implant surgical guide and the preformed tooth positioner, among others.

Section 4 Expansion of Medical Devices Available
for Online Sale

Origin of Policy

In order to take care of both the demand for and safety of medical devices suitable for use

at home, the Administration announced medical devices that may be sold over the Internet shall
follow the four major principles of “home use, non-invasion, non-implantation, and no need for
instructions from professionals.” Medical device companies and drug stores may apply for and
obtain approval from the local health authority, in order to sell medical devices through distance
sales channels.

Implementation Measures

1. As of November 1, 2012, according to the characteristics of medical devices, the Administration

has gradually lifted the ban on items that may be purchased online. Medical Device Dealers
with physical operating sites may apply to local health authorities for a permit and once it is
approved, they may sell low-risk medical devices in Class 1 through distance sales channels.
2. The ban on five items were lifted on January 2, 2014, including body fat monitors, condoms,
and sanitary pads as Class 2 medical devices that were suitable for use at home as they were
non-invasive, non-implanted, and did not require instructions from professionals.
3. The ban on 8 items were lifted on October 15, 2015, including surgical masks, alcohol prep
pads, alcohol cotton balls, iodine prep pads, iodine swabs, iodine gauze, Vaseline gauze, suture-
free tape, contact lens cleaning and care products, medical image recording and transmission

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