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Food and Drug Administration


Policies and Outcomes

1. Harmonization with International Regulations and Standards

In 2014, amendments to medical device regulations and administrative directions include


Requirements of Online Sales for Medical Devices by Pharmaceutical Firms, Regulations for

Governing the Management of Medical Device, Regulations of Pharmaceutical Manufacturer

Inspection, Application for medical device designation, Technical criteria for home-use blood sugar

monitoring systems, Medical Device license transfer documents, Reference Guide for Nano-Medical

Devices Identification


and Good Submission Practice (GSP) for the registration of medical devices


Details are given in Appendix 1 Annex Table 13.

2. Medical Devices Review

(1) Classification of Medical Devices

Depending on the characteristics and the degree of risk of medical device, medical devices

in Taiwan are divided into 17 categories (more than 6,200 variety of items) and three classes

including Class 1 (low risk), Class 2 (moderate risk) and Class 3 (high risk). Up to the end of

2014, the number of valid medical device licenses was 37,798, including 23.6% for domestic

products and 76.4% for imported products, respectively.

(2) Review Time and Quality for Medical Device

a. Comprehensive Revolution of the Medical Device Registration Mechanisms

Streamlined and priority review mechanisms were established according to the level of risk for

medical device, and each of these two mechanisms can reduce review time. By the end of

2014, 1,002 medical device international standards and 90 medical device guidance documents

announced by US FDA were recognized, and 46 domestic preclinical testing guidance documents

were announced to provide direction for the medical device industry and improve the consistency

and transparency of the medical device registration.

b. Improving Review Time and Enhancing Review Capabilities

In 2014, a total of 5,218 medical device registration reviews were completed. The review time is

equivalent to the level of global leading countries. The reviews included 113 cases of innovative

medical devices with no similar items, which required an average review duration of about 178

days, a 13% reduction from the duration incurred in 2013. In 2014, TFDA also approved a world-

leading total of six innovative medical devices (versus a total of one such device approved in 2013).

(3) Establishment of Quality Medical Device Clinical Trials Environment

In 2014, a total of 64 clinical trial applications were reviewed with an average review time of 38 days, a 30%

reduction from 54 days in 2012. From 2012 to 2014, the number of multi-country and multi-center clinical

trials for medical devices had increased from 1 to 5. High ranking medical device clinical trial professionals

have also been dispatched to the United States, Europe, Japan, and other countries for training to support

multi-country collaborative medical device research and development. Five major Taipei hospitals (Chang

Gung, Wanfang, Taipei Medical University Hospital, Veterans General Hospital, and National Taiwan University

Hospital) signed multi-country medical device clinical trial partnership programs with major international

corporations (Sumitomo, Cook, Swissray, Siemens, and Medtronic) helping to convert Taiwan into an

important hub for entering the Asia Pacific market and other emerging markets (Figure 5-2).

(4) Comprehensive Counseling Mechanism

a. Establishing a Three-Step Consultation Network

In response to the rapid development of Taiwan's medical device industry, TFDA has encouraged

the research and development of innovative medical devices. TFDA has thus established a