Page 52 - Taiwan Food and Drug Administration 2016 Annual Report

Taiwan Food and Drug Adminstration

Policies and Outcomes
1. International Harmonization of Regulatory Standards
Medical device regulations and standards promulgated and revised in 2015 include Reference
Guidance for Medical Software Categorization and Classification, List of Recognized Standards
for Medical Devices, and Regulation of Unique Device Identification (UDI) System for Medical
Devices. Refer to Table 15 of Annex I for more details. In 2015, a total of five communication
meetings and 24 work meetings with experts and stakeholders were held, and global regulatory
practices of medical devices were referenced to develop a full text draft of act specifically
governing the medical devices in Taiwan.
2. Review of Medical Devices
(1) Categorization and Classification of Medical Devices
Medical devices in Taiwan are divided into three classes and 17 major categories (with over
6,200 items) according to their different characteristics and risk levels. They include Class
1 (low risk), Class 2 (medium risk) and Class 3 (high risk) medical devices. As of the end of
2015, a total of 40,841 valid medical device licenses had been issued, of which 23.8% were for
domestic products while 76.2% were for imported products (Figure 2-4-2).
23.8%

76.2%
Domestic
products

Imported
products

Proportion for the number of valid licenses of
Figure 2-4-2 domestic and imported medical devices in 2015

(2) Comprehensive Review Mechanisms for the Registration of Medical Devices
a. Recognized Standards and Product Guidances for Medical Devices
To improve the quality of medical device reviews and shorten review time, TFDA adopted
recognized international standards on medical devices and developed product technical
guidance documents on medical devices. As of the end of 2015, TFDA had recognized a total
of 918 international standards on medical devices and 90 medical device product guidances
from the U.S. Food and Drug Administration (FDA), as well as announced 50 product technical
guidances on medical devices.
b. Optimization Measures for Review Processes of Medical Device Registration
Since November 2015, a pilot run of a 2-phase administrative and technical review system was
initiated for the registration of Class 2 and Class 3 (medium and high risk) medical devices.
Upon receiving an application, the TFDA will complete a preliminary screening of administrative
documents within 10 days before initiating expedited review of technical data to optimize the
review process. In 2015, a total of 5,321 medical device registration reviews were completed,
including 123 innovative medical devices with no similar products. This was a 9% increase
(113 applications) compared to 2014, improving public accessibility and utilization of emerging
medical devices in Taiwan.
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