Page 35 - 2017食品藥物管理署年報(英文版)

2017 Taiwan Food and Drug Administration Annual Report Chapter 2. Legal Environment and Registration

B. Optimization and reformation of review mechanisms for medical devices
(A) Recognized international standards and product guidances for medical
devices
As of the end of 2016, TFDA had recognized a total of 110 product
guidances for medical devices, 918 international standards on medical

devices and 56 pre-clinical test guidances for medical device products to
improve the consistency and transparency of review processes (Figure 2-8).
(B) Optimize Review Models and Quality of Medical Devices
To fully promote reformation of review processes for medical devices
registration, TFDA establishes expedited and prioritized review mechanisms
for medical device products based on risk classifications. The associated
measures are as follows:
a. For on-site expedited applications and registration of Class 1 medical
devices registration, it has been changed to telephone reservation system

since February 1, 2016. Additionally, TFDA completed the establishment
of online application system for Class 1 medical devices to improve the
efficiency of registration.
b. Promote preliminary screening of administrative documents for Class
2 and 3 medical devices registration. Additionally, a total of 32 Class 2

A total of
110 product guidances
for medical devices
918 international
standards on
medical devices

Improve
the consistency
and transparency
of review Recognized
processes international
standards and
product guidances
for medical
56 pre-clinical test devices
guidances for
medical device products

Figure 2-8 Recognized international standards and product guidances for medical devices

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