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2014 Annual Report
(3) Establish quality medical device clinical trial environment
In 2013, 68 clinical trial application case reviews were completed. From 2012 to 2013,
the number of multi-country multi-center clinical trials (MCT) had increased from 1 to 6.
Three medical device Good Clinical Practice (GCP) inspections were completed with
the involvement of foreign experts. In order to train seeded personnel for conducting
clinical trials, 10 physicians were selected and sent to Europe, United States, Japan
and other countries to learn clinical trials for medical device.
(4) Comprehensive consultation program
a. Build a 3-step consultation network
In response to the rapid development of domestic medical device industry, the
TFDA has established a comprehensive regulatory consultation network which
strengthened the three-stage counseling mechanism. Furthermore, a regulatory
counselling center was established in consolidation with the capacity of third party
providing counselling service (Fig. 4-3). In 2013, TFDA expanded telephone service
lines to four lines. A total of 11,802 calls were received.
b. Outcomes for consulting program
By the end of 2013, TFDA has successfully assisted 11 cases through to approval,
7 cases entering clinical trials and 2 technology transfers into the industry. Some
examples include the global first clinical trial of an advanced treatment for repairing
cartilage defect, the clinical trial of an innovative negative-pressure designed sleep
apnea therapeutic device, and the marketing approval for domestic first one-stage
dental implants. By the end of 2013, there are still 8 consultation cases ongoing.
Fig. 4-3 Comprehensive consultation program for medical device industry
Consultation Network
Three-Stages Consultation
First Stage
：
Consultation on
general regulatory
requirements
Third Stage
：
Index cases
consultation
services
Second Stage
：
Consultation for
individual projects
Medical
Device
Seeds
Regulator
Center
for Drug
Evaluation
(CDE)
Food and Drug
Administration
(TFDA)
Establish Industry
Communication Platform
Active counselling
for Domestic Medical Devices
Online Information
Letter for Consultation
Medical Device regulations
Counselling Centre &
Consulting line