Page 33 - 2017食品藥物管理署年報(英文版)
P. 33
2017 Taiwan Food and Drug Administration Annual Report Chapter 2. Legal Environment and Registration
Professional Consultation System
for Pharmaceutical Projects
early benefits
innovativeness
legal compliance
contribution
Figure 2-6 Professional Consultation System for Pharmaceutical Projects
(3) Medical devices and cosmetics registration and advertisement examination
A. Medical devices and cosmetics pre-market registration and advertisement
examination
(A) Medical devices in Taiwan are divided into three classes, including Class
1 (low risk), Class 2 (medium risk) and Class 3 (high risk), and 17 major
categories (approximately 1,700 items) according to their different
characteristics and risk levels. Cosmetics in Taiwan are divided into regular
and medicated cosmetics. In addition to regular cosmetics, medical devices
and medicated cosmetics must complete registration before marketing. The
manufacturing and sales of medical devices and medicated cosmetics can
only be implemented after obtaining product marketing permits.
(B) In 2016, 143 innovative medical devices with no similar products
registration reviews were completed. This was a 16% increase compared to
2015, improving public accessibility and utilization of emerging medical
devices in Taiwan.
31
