Page 47 - 2017食品藥物管理署年報(英文版)

2017 Taiwan Food and Drug Administration Annual Report Chapter 3. Source and Manufacturing Management

3. Medical devices source management

(1) Manufacturer registration management
Before a medical device can be placed on the market, the quality system of its
manufacturer must comply with Taiwan’s medical device GMP standard. Medical device
importers can apply for compliance with Taiwan’s Quality System Documentation (QSD)
requirement, or apply for on-site audits for overseas medical device manufacturers. For
medical device manufacturers located in Taiwan, on-site audits will be the primary means
of inspection. See Figure 3-5 for valid GMP registration letters for domestic medical

device manufacturers and QSD registration letters for imported medical devices issued
by the end of 2016.

(2) The inventory of medical device licenses with expired GMP/QSD registration
letters
To ensure the quality of medical devices, a phased process for reviewing medical
device licenses with expired GMP/QSD registration letters were completed in 2016.
The review resulted in suspension of 112 medical device licenses relating to 58
pharmaceutical firms. These companies were notified to have their manufacturers re-

5000

4500 GMP
GMP
4000 3,640 3,800
GMP
Number of 3500 GMP 3,213 GMP
valid GMP 3,065 3,057
GMP/QSD 3000
registration 2,777
letters for 2500
medical
devices
2000
1500 GMP
1000 1,340 685 669
486 531 568 565 QSD QSD
500 236 QSD QSD QSD QSD
QSD
0
Year 99 100 101 102 103 104 105

GMP Valid GMP registration letters Valid QSD registration letters
QSD

Figure 3-5 Number of valid GMP/QSD registration letters for medical devices

45