50 / 132
Food and Drug Administration
50
Project title
Total case
no.
Surveillance issues
Quality
a
Package labeling
Conforming
no.
Nonconforming
no.
Conforming
no.
Nonconforming
no.
Survey on the quality of surgical
gowns in Taiwan
b
8
4
3
8
0
Survey on the quality of marketed
medical masks in Taiwan
25
21
4
25
0
Hepatitis B surface antigen and
antibody assay performance
surveillance
22
22
0
21
1
Sterility surveillance for medical-use
sterile phlegm removal device and
tracheostomy tube
83
80
3
26
57
Sterility surveillance for catgut or
absorbable suture
69
69
0
40
29
Sterility surveillance for urethral
catheters
9
9
0
9
0
Total number (Percentage)
216
（
100
）
205
（
94.9
）
10
（
4.6
）
129
（
59.7
）
87
（
40.3
）
Note:
a: For surgical gowns and marketed medical masks, passing criteria would depend on whether or not the item is capable of
meeting the registered specifications.
b: There is one specimen that is not included within the scope of the quality surveillance criteria for surgical gown liquid
protection.
Medical devices Number of inspected
counties /cities
Medical, aesthetic
dental, and orthopedic
clinics
Product labeling
Inspected
cases
Nonconforming
cases
Nonconforming
rate
Hyaluronic acid
dermal fillers
5
12
27
5
18.5
Surgical sutures
5
28
71
5
7.0
Dental implants
5
11
19
8
42.1
Hyaluronic acid
implants for joint
cavities
5
12
23
7
30.4
Total
5
40
a
140
25
17.9
Note: a: single clinic may undergo two or more product audits.
Table 5-2
Quality surveillance results of Medical Devices in 2014
Table 5-3
Statistical analysis of joint audit results of medical devices in 2014