1 
 Comparison Table 
Draft Amendment to the Annex to Article 4 
Amendments Current regulations 
Explanation classifi
cation 
number  English name Class  Identification classifi
cation 
number  English name Class  Identification 
A.1040  Aldolase test 
system 1 An aldolase test system is 
a device intended to 
measure the activity of the 
enzyme aldolase in serum 
or plasma. Aldolase 
measurements are used in 
the diagnosis and 
treatment of the early 
stages of acute hepatitis 
and for certain muscle 
diseases such as 
progressive Duchenne-
type muscular dystrophy. A.1040  Aldolase test 
system 1 An aldolase test system is a 
device intended to measure 
the activity of the enzyme 
aldolase in serum or plasma. 
Aldolase measurements are 
used in the diagnosis and 
treatment of the early stages 
of acute hepatitis and for 
certain muscle diseases such 
as progressive Duchenne-
type muscular dystrophy. 1. Amend the 
Chinese name 
and the wording 
in the 
identification. 
2. Based on the 
Chinese 
translation of 
medical terms 
from the 
National 
Academy for 
Educational 
Research and the 
advice of 
experts. 
A.1045  Aldosterone test 
system 2 An aldosterone test system 
is a device intended to 
measure the hormone 
aldosterone in serum and A.1045  Aldosterone test 
system 2 An aldosterone test system 
is a device intended to 
measure the hormone 
aldosterone in serum and 1. Amend the 
Chinese name 
and the wording 2 
 urine. Aldosterone 
measurements are used in 
the diagnosis and 
treatment of primary 
aldosteronism (a disorder 
caused by the excessive 
secretion of aldosterone by 
the adrenal gland), 
hypertension caused by 
primary aldosteronism, 
selective 
hypoaldosteronism, 
edematous states, and 
other conditions of 
electrolyte imbalance. urine. Aldosterone 
measurements are used in 
the diagnosis and treatment 
of primary aldosteronism (a 
disorder caused by the 
excessive secretion of 
aldosterone by the adrenal 
gland), hypertension caused 
by primary aldosteronism, 
selective 
hypoaldosteronism, 
edematous states, and other 
conditions of electrolyte 
imbalance. in the 
identification. 
2. Based on the 
Chinese 
translation of 
medical terms 
from the 
National 
Academy for 
Educational 
Research and the 
advice of 
experts. 
A.1075  Androstenedione 
test system 1 An androstenedione test 
system is a device 
intended to measure 
androstenedione (a 
substance secreted by the 
testes, ovary, and adrenal 
glands) in serum. 
Androstenedione 
measurements are used in 
the diagnosis and 
treatment of females with 
excessive levels of 
androgen (male sex 
hormone) production. A.1075  Androstenedione 
test system 1 An androstenedione test 
system is a device intended 
to measure androstenedione 
(a substance secreted by the 
testes, ovary, and adrenal 
glands) in serum. 
Androstenedione 
measurements are used in 
the diagnosis and treatment 
of females with excessive 
levels of androgen (male sex 
hormone) production. 1. Amend the 
Chinese name 
and the wording 
in the 
identification. 
2. Based on the 
Chinese 
translation of 
medical terms 
from the 
National 
Academy for 
Educational 
Research and the 3 
 advice of 
experts. 
A.1355  Integrated 
continuous 
glucose 
monitoring 
system 2,3 An integrated continuous 
glucose monitoring system 
(iCGM) is intended to 
automatically measure 
glucose in bodily fluids 
continuously or frequently 
for a specified period of 
time.  
Classification: (1) Class 2 
devices are intended to be 
used alone for diabetes 
self-management. (2) 
Class 3 devices are 
intended to transmit 
glucose measurement data 
to automated insulin 
dosing systems, and to 
adjust insulin dose.     1. A new 
classification 
number. 
2. Based on the 
U.S. FDA 
regulations and 
the current 
management of 
our country, the 
new product 
item is divided 
into class 2 and 
3. 
A.1390  5-Hydroxyindole 
acetic 
acid/serotonin test 
system 1 A 5-hydroxyindole acetic 
acid/serotonin test system 
is a device intended to 
measure 5-hydroxyindole 
acetic acid/serotonin in 
urine. 
Measurements of 5-
hydroxyindole acetic 
acid/serotonin are used in 
the diagnosis and A.1390  5-Hydroxyindole 
acetic 
acid/serotonin test 
system 1 A 5-hydroxyindole acetic 
acid/serotonin test system is 
a device intended to 
measure 5-hydroxyindole 
acetic acid/serotonin  in 
urine. 
Measurements of 5-
hydroxyindole acetic 
acid/serotonin are used in 
the diagnosis and treatment 1. Amend the 
identification. 
2. Based on the 
Chinese 
translation of 
medical terms 
from the 
National 
Academy for 
Educational 4 
 treatment of carcinoid 
tumors of endocrine tissue.  of carcinoid tumors of 
endocrine tissue. Research and the 
advice of 
experts. 
A.1655  Pyruvic acid test 
system 1 A pyruvic acid test system 
is a device intended to 
measure pyruvic acid (an 
intermediate compound in 
the metabolism of 
carbohydrate) in plasma. 
Measurements obtained by 
this device are used in the 
evaluation of electrolyte 
metabolism, and in the 
diagnosis and treatment of 
acid-base and electrolyte 
disturbances or anoxia (the 
reduction of oxygen in 
body tissues).  A.1655  Pyruvic acid test 
system 1 A pyruvic acid test system 
is a device intended to 
measure pyruvic acid (an 
intermediate compound in 
the metabolism of 
carbohydrate) in plasma. 
Measurements obtained by 
this device are used in the 
evaluation of electrolyte 
metabolism and in the 
diagnosis and treatment of 
electrolyte disturbances or 
anoxia (the reduction of 
oxygen in body tissues). 1. Amend the 
wording in the 
identification. 
 
A.1680  Testosterone test 
system 1 A testosterone test system 
is a device intended to 
measure testosterone (a 
male sex hormone) in 
serum, plasma, and urine. 
Measurement of 
testosterone are used in the 
diagnosis and treatment of 
disorders involving the 
male sex hormones 
(androgens), including 
primary and secondary A.1680  Testosterone test 
system 1 A testosterone test system is 
a device intended to 
measure testosterone (a 
male sex hormone) in 
serum, plasma, and urine. 
Measurement of 
testosterone are used in the 
diagnosis and treatment of 
disorders involving the male 
sex hormones (androgens), 
including primary and 
secondary hypogonadism, 1. Amend the 
Chinese name 
and the wording 
in the 
identification. 
2. Based on the 
Chinese 
translation of 
medical terms 
from the 
National 
Academy for 5 
 hypogonadism, delayed or 
precocious puberty, 
impotence in male’s and, 
in female’s hirsutism 
(excessive hair) and 
virilization 
(masculinization) due to 
tumors, polycystic ovaries, 
and adrenogenital 
syndromes. delayed or precocious 
puberty, impotence in 
male’s and, in female’s 
hirsutism (excessive hair) 
and virilization 
(masculinization) due to 
tumors, polycystic ovaries, 
and adrenogenital 
syndromes. Educational 
Research and the 
advice of 
experts. 
A.2270  Thin-layer 
chromatography 
system for clinical 
use 1 A thin-layer 
chromatography (TLC) 
system for clinical use is a 
device intended to separate 
one or more drugs or 
compounds from a 
mixture. The mixture of 
compounds is absorbed 
onto a stationary phase or 
thin layer of inert material 
(e.g., cellulose, alumina, 
etc.) and eluted off by a 
moving solvent (moving 
phase) until equilibrium 
occurs between the two 
phases. A.2270  Thin-layer 
chromatography 
system for clinical 
us 1 A thin-layer 
chromatography (TLC) 
system for clinical use is a 
device intended to separate 
one or more drugs or 
compounds from a mixture. 
The mixture of compounds 
is absorbed onto a stationary 
phase or thin layer of inert 
material (e.g., cellulose, 
alumina, etc.) and eluted off 
by a moving solvent 
(moving phase) until 
equilibrium occurs between 
the two phases. 1. Amend the 
Chinese wording 
in the 
identification. 
2. Based on the 
Chinese 
translation of 
medical terms 
from the 
National 
Academy for 
Educational 
Research and the 
advice of 
experts. 6 
 A.3050  Breath-alcohol 
test system 1 A breath-alcohol test 
system is a device 
intended to measure 
alcohol in the human 
breath.  Measurements 
obtained by this device are 
used in the diagnosis of 
alcohol intoxication. A.3050  Breath-alcohol 
test system 1 A breath-alcohol test system 
is a device intended to 
measure alcohol in the 
human breath. 
Measurements obtained by 
this device are used in the 
diagnosis of alcohol 
intoxication. 1. Amend the 
Chinese name 
and the wording 
in the 
identification. 
2. Based on the 
Chinese 
translation of 
medical terms 
from the 
National 
Academy for 
Educational 
Research and the 
advice of 
experts. 
A.3380  Ethosuximide test 
system 2 An ethosuximide test 
system is a device 
intended to measure 
ethosuximide, an 
antiepileptic drug, in 
human specimens. 
Measurements obtained by 
this device are used in the 
diagnosis and treatment of 
ethosuximide overdose 
and in monitoring levels of 
ethosuximide to ensure 
appropriate therapy. A.3380  Ethosuximide test 
system 2 An ethosuximide test 
system is a device intended 
to measure ethosuximide, an 
antiepileptic drug, in human 
specimens. 
Measurements obtained by 
this device are used in the 
diagnosis and treatment of 
ethosuximide overdose and 
in monitoring levels of 
ethosuximide to ensure 
appropriate therapy. 1. Amend the 
Chinese name 
and the wording 
in the 
identification. 
2. Based on the 
Chinese 
translation of 
medical terms 
from the 
National 
Academy for 
Educational 
Research and the 7 
 advice of 
experts. 
A.3555  Lidocaine test 
system 2 A lidocaine test system is 
a device intended to 
measure lidocaine, an 
antiarrhythmic and 
anticonvulsant drug, in 
serum and plasma. 
Measurements obtained by 
this device are used in the 
diagnosis and treatment of 
lidocaine overdose or in 
monitoring levels of 
lidocaine to ensure 
appropriate therapy. A.3555  Lidocaine test 
system 2 A lidocaine test system is a 
device intended to measure 
lidocaine, an antiarr hythmic 
and anticonvulsant drug, in 
serum and plasma. 
Measurements obtained by 
this device are used in the 
diagnosis and treatment of 
lidocaine overdose or in 
monitoring levels of 
lidocaine to ensure 
appropriate therapy. 1. Amend the 
Chinese name 
and the wording 
in the 
identification. 
2. Based on the 
Chinese 
translation of 
medical terms 
from the 
National 
Academy for 
Educational 
Research and the 
advice of 
experts. 
A.3560  Lithium test 
system 2 A lithium test system is a 
device intended to measure 
the concentration of 
lithium (from the drug 
lithium carbonate) in 
serum or plasma. 
Measurements of lithium 
are used to assure that the 
proper drug dosage is 
administered in the 
treatment of patients with 
mental disturbances, such  A.3560  Lithium test 
system 2 A lithium test system is a 
device intended to measure 
lithium (from the drug 
lithium carbonate) in serum 
or plasma. Measurements of 
lithium are used to assure 
that the proper drug dosage 
is administered in the 
treatment of patients with 
mental disturbances, such as 
manic-depressive illness 
(bipolar disorder ). 1. Amend the 
Chinese wording 
in the 
identification. 
2. Remove 
inappropriate 
text.  8 
 as manic-depressive 
illness. 
A.3580  Lysergic acid 
diethylamide 
(LSD) test system  2 A lysergic acid 
diethylamide (LSD) test 
system is a device 
intended to measure 
lysergic acid diethylamide, 
a hallucinogenic drug, in 
serum, urine, and gastric 
contents. Measurements 
obtained by this device are 
used in the diagnosis and 
treatment of LSD use or 
overdose. A.3580  Lysergic acid 
diethylamide 
(LSD) test system  2 A lysergic acid 
diethylamide (LSD) test 
system is a device intended 
to measure lysergic acid 
diethylamide, a 
hallucinogenic drug, in 
serum, urine, and gastric 
contents. Measurements 
obtained by this device are 
used in the diagnosis and 
treatment of LSD use or 
overdose. 1. Amend the 
Chinese name 
and the wording 
in the 
identification. 
2. Based on the 
Chinese 
translation of 
medical terms 
from the 
National 
Academy for 
Educational 
Research and the 
advice of 
experts. 
A.3630  Methaqualone test 
system 2 A methaqualone test 
system is a device 
intended to measure 
methaqualone, a hypnotic 
and sedative drug, in urine. 
Measurements obtained by 
this device are used in the 
diagnosis and treatment of A.3630  Methaqualone test 
system 2 A methaqualone test system 
is a device intended to 
measure methaqualone, a 
hypnotic and sedative drug, 
in urine. Measurements 
obtained by this device are 
used in the diagnosis and 
treatment of methaqualone 
use or overdose. 1. Amend the 
Chinese name 
and the wording 
in the 
identification. 
2. Based on the 
Chinese 
translation of 
medical terms 9 
 methaqualone use or 
overdose. from the 
National 
Academy for 
Educational 
Research and the 
advice of 
experts. 
A.3645  Neuroleptic drugs 
radioreceptor 
assay test system 2 A neuroleptic drugs 
radioceptor assay test 
system is a device 
intended to measure in 
serum or plasma the 
dopamine receptor 
blocking activity of 
neuroleptic drugs and their 
active metabolites.  
A neuroleptic drug has 
anti-psychotic action 
affecting principally 
psychomotor activity, is 
generally without hypnotic 
effects, and is a 
tranquilizer. 
Measurements obtained by 
this device are used to aid 
in determining whether a 
patient is taking the 
prescribed dosage level of 
such drugs. A.3645  Neuroleptic drugs 
radioreceptor 
assay test system 2 A neuroleptic drugs 
radioceptor assay test 
system is a device intended 
to measure in serum or 
plasma the dopamine 
receptor blocking activity of 
neuroleptic drugs and their 
active metabolites.  
A neuroleptic drug has anti-
psychotic action affecting 
principally psychomotor 
activity, is generally without 
hypnotic effects, and is a 
tranquilizer. Measurements 
obtained by this device are 
used to aid in determining 
whether a patient is taking 
the prescribed dosage level 
of such drugs. 1. Amend the 
Chinese name 
and the wording 
in the 
identification. 
2. Based on the 
Chinese 
translation of 
medical terms 
from the 
National 
Academy for 
Educational 
Research and the 
advice of 
experts. 10 
 A.3670  Phenothiazine test 
system 2 A phenothiazine test 
system is a device 
intended to measure any of 
the drugs of the 
phenothiazine class in 
human specimens. 
Measurements obtained by 
this device are used in the 
diagnosis and treatment of 
phenothiazine use or 
overdose. A.3670  Phenothiazine test 
system 2 A phenothiazine test system 
is a device intended to 
measure any of the drugs of 
the phenothiazine class in 
human specimens. 
Measurements obtained by 
this device are used in the 
diagnosis and treatment of 
phenothiazine use or 
overdose. 1. Amend the 
Chinese name 
and the wording 
in the 
identification. 
2. Based on the 
Chinese 
translation of 
medical terms 
from the 
National 
Academy for 
Educational 
Research and the 
advice of 
experts. 
A.3870  Cannabinoid test 
system 2 A cannabinoid test system 
is a device intended to 
measure any of the 
cannabinoids, 
hallucinogenic compounds 
endogenous to marihuana, 
in serum, plasma, saliva, 
and urine. Cannabinoid 
compounds include delta-
9-tetrahydrocannabinol, 
cannabidiol, cannabinol, 
and cannabichromene. 
Measurements obtained by 
this device are used in the 
diagnosis and treatment of A.3870  Cannabinoid test 
system 2 A cannabinoid test system is 
a device intended to 
measure any of the 
cannabinoids, 
hallucinogenic compounds 
endogenous to marihuana, 
in serum, plasma, saliva, 
and urine. Cannabinoid 
compounds include delta-9-
tetrahydrocannabinol, 
cannabidiol, cannabinol, and 
cannabichromene. 
Measurements obtained by 
this device are used in the 
diagnosis and treatment of 1. Amend the 
Chinese wording 
in the 
identification. 
2. Based on the 
Chinese 
translation of 
medical terms 
from the 
National 
Academy for 
Educational 
Research and the 11 
 cannabinoid use or abuse 
and in monitoring levels of 
cannabinoids during 
clinical investigational 
use. cannabinoid use or abuse 
and in monitoring levels of 
cannabinoids during clinical 
investigational use. advice of 
experts. 
A.3880  Theophylline test 
system 2 A theophylline test system 
is a device intended to 
measure theophylline (a 
drug used for stimulation 
of the muscles in the 
cardiovascular, respiratory, 
and central nervous 
systems) in serum and 
plasma. Measurements 
obtained by this device are 
used in the diagnosis and 
treatment of theophylline 
overdose or in monitoring 
levels of theophylline to 
ensure appropriate therapy.  A.3880  Theophylline test 
system 2 A theophylline test system 
is a device intended to 
measure theophylline (a 
drug used for stimulation of 
the muscles in the 
cardiovascular, respiratory, 
and central nervous 
systems) in serum and 
plasma. Measurements 
obtained by this device are 
used in the diagnosis and 
treatment of theophylline 
overdose or in monitoring 
levels of theophylline to 
ensure appropriate therapy. 1. Amend the 
Chinese name 
and the wording 
in the 
identification. 
2. Based on the 
Chinese 
translation of 
medical terms 
from the 
National 
Academy for 
Educational 
Research and the 
advice of 
experts. 
B.3700 Whole slide 
imaging system  2 The whole slide imaging 
system is an automated 
digital slide creation, 
viewing, and management 
system intended as an aid 
to the pathologist to 
review and interpret digital 
images of pathology 
slides. B.3700  Whole slide 
imaging system . 2 The whole slide imaging 
system is an automated 
digital slide creation, 
viewing, and management 
system intended as an aid to 
the pathologist to review 
and interpret digital images 
of surgical pathology slides.  1. Amend the 
wording in the 
identification. 
2. Delete the word 
" surgical " to 
conform to the 
current 
management 
model. 12 
 B.5200 Automated cell 
counter 2 An automated cell counter 
is a fully-automated or 
semi-automated device 
used to count red blood 
cells, white blood cells, or 
blood platelets using a 
sample of the patient's 
peripheral blood (blood 
circulating in one of the 
body's extremities, such as 
the arm). These devices 
may also measure 
hemoglobin or hematocrit 
and may also calculate or 
measure one or more of 
the red cell indices (the 
erythrocyte mean 
corpuscular volume, the 
mean corpuscular 
hemoglobin, or the mean 
corpuscular hemoglobin 
concentration). These 
devices may use either an 
electronic particle 
counting method or an 
optical counting method. B.5200  Automated cell 
counter 2 An automated cell counte r is 
a fully-automated or semi-
automated device used to 
count red blood cells, white 
blood cells, or blood 
platelets using a sample of 
the patient's peripheral 
blood (blood circulating in 
one of the body's 
extremities, such as the 
arm). These devices may 
also measure hemoglobin or 
hematocrit and may also 
calculate or measure one or 
more of the red cell indices 
(the erythrocyte mean 
corpuscular volume, the 
mean corpuscular 
hemoglobin, or the mean 
corpuscular hemoglobin 
concentration). These 
devices may use either an 
electronic particle counting 
method or an optical 
counting method. 1. Amend the 
Chinese wording  
in the 
identification. 
2. Based on the 
Chinese 
translation of 
medical terms 
from the 
National 
Academy for 
Educational 
Research and the 
advice of 
experts.  
B.5300 Red cell indices 
device 2 A red cell indices device, 
usually part of a larger 
system, calculates or 
directly measures the 
erythrocyte mean B.5300  Red cell indices 
device 2 A red cell indices device, 
usually part of a larger 
system, calculates or 
directly measures the 
erythrocyte mean 1. Amend the 
Chinese wording  
in the 
identification. 13 
 corpuscular volume 
(MCV), the mean 
corpuscular hemoglobin 
(MCH), and the mean 
corpuscular hemoglobin 
concentration (MCHC). 
The red cell indices are 
used for the differential 
diagnosis of anemias. corpuscular volume (MCV), 
the mean corpuscular 
hemoglobin (MCH), and the 
mean corpuscular 
hemoglobin concentration 
(MCHC). The red cell 
indices are used for the 
differential diagnosis of 
anemias. 2. Based on the 
Chinese 
translation of 
medical terms 
from the 
National 
Academy for 
Educational 
Research and the 
advice of 
experts. 
B.5600 Automated 
hematocrit 
instrument 2 An automated hematocrit 
instrument is a fully 
automated or semi-
automated device which 
may or may not be part of 
a larger system. This 
device measures the 
packed red cell volume of 
a blood sample to 
distinguish normal from 
abnormal states, such as 
anemia and erythrocytosis 
(an increase in the number 
of red cells). B.5600  Automated 
hematocrit 
instrument 2 An automated hematocrit 
instrument is a fully 
automated or semi-
automated device which 
may or may not be part of a 
larger system. This device 
measures the packed red cell 
volume of a blood sample to 
distinguish normal from 
abnormal states, such as 
anemia and erythrocytosis 
(an increase in the number 
of red cells). 1. Amend the 
Chinese name 
and the wording 
in the 
identification. 
2. Based on the 
Chinese 
translation of 
medical terms 
from the 
National 
Academy for 
Educational 
Research and the 
advice of 
experts. 
B.7440 Electrophoretic 
hemoglobin 
analysis system 2 A hemoglobin 
electrophoresis analysis 
system is a device that B.7440  Electrophoretic 
hemoglobin 
analysis system 2 An electrophoretic 
hemoglobin analysis system 
is a device that 1. Amend the 
Chinese name 
and the wording 14 
 electrophoretically 
separates and identifies 
normal and abnormal 
hemoglobin types as an aid 
in the diagnosis of anemia 
or erythrocytosis 
(increased total red cell 
mass) due to a hemoglobin 
abnormality.  electrophoretically separates 
and identifies normal and 
abnormal hemoglobin types 
as an aid in the diagnosis of 
anemia or erythrocytosis 
(increased total red cell 
mass) due to a hemoglobin 
abnormality. in the 
identification. 
2. Based on the 
Chinese 
translation of 
medical terms 
from the 
National 
Academy for 
Educational 
Research and the 
advice of 
experts. 
B.7735 Prothrombin-
proconvertin test 
and thrombotest 2 The prothrombin-
proconvertin test and 
thrombotest are devices 
used in the regulation of 
coumarin therapy 
(administration of a 
coumarin anticoagulant 
such as sodium warfarin in 
the treatment of venous 
thrombosis and pulmonary 
embolism) and as a 
diagnostic test in 
conjunction with, or in 
place of, the Quick 
prothrombin time test to 
detect coagulation 
disorders. B.7735  Prothrombin-
proconvertin test 
and thrombotest 2 The prothrombin-
proconvertin test and 
thrombotest are devices 
used in the regulation of 
coumarin therapy 
(administration of a 
coumarin anticoagulant such 
as sodium warfarin in the 
treatment of venous 
thrombosis and pulmonary 
embolism) and as a 
diagnostic test in 
conjunction with, or in place 
of, the Quick prothrombin 
time test to detect 
coagulation disorders. 1. Amend the 
Chinese name 
and the wording 
in the 
identification. 
2. Based on the 
Chinese 
translation of 
medical terms 
from the 
National 
Academy for 
Educational 
Research and the 
advice of 
experts. 15 
 B.7750 Prothrombin time 
test 2 A prothrombin time test is 
a device used as a general 
screening procedure for 
the detection of possible 
clotting factor deficiencies 
in the extrinsic coagulation 
pathway, which involves 
the reaction between 
coagulation factors III and 
VII, and to monitor 
patients receiving 
coumarin therapy (the 
administration of one of 
the coumarin 
anticoagulants in the 
treatment of venous 
thrombosis or pulmonary 
embolism). B.7750  Prothrombin time 
test 2 A prothrombin time test is a 
device used as a general 
screening procedure for the 
detection of possible 
clotting factor deficiencies 
in the extrinsic coagulation 
pathway, which involves the 
reaction between 
coagulation factors III and 
VII, and to monitor patients 
receiving coumarin therapy 
(the administration of one of 
the coumarin anticoagulants 
in the treatment of venous 
thrombosis or pulmonary 
embolism). 1. Amend the 
Chinese name 
and the wording 
in the 
identification. 
2. Based on the 
Chinese 
translation of 
medical terms 
from the 
National 
Academy for 
Educational 
Research and the 
advice of 
experts. 
B.7875 Thrombin time 
test 2 A thrombin time test is a 
device used to measure 
fibrinogen concentration 
and detect fibrin or 
fibrinogen split products 
for the evaluation of 
bleeding disorders. B.7875  Thrombin time 
test 2 A thrombin time test is a 
device used to measure 
fibrinogen concentration and 
detect fibrin or fibrinogen 
split products for the 
evaluation of bleeding 
disorders. 1. Amend the 
Chinese name 
and the wording 
in the 
identification. 
2. Based on the 
Chinese 
translation of 
medical terms 
from the 
National 
Academy for 
Educational 16 
 Research and the 
advice of 
experts. 
B.7900 Thromboplastin 
generation test 1 A thromboplastin 
generation test is a device 
used to detect and identify 
coagulation factor 
deficiencies and 
coagulation inhibitors. B.7900  Thromboplastin 
generation test 1 A thromboplastin generation 
test is a device used to detect 
and identify coagulation 
factor deficiencies and 
coagulation inhibitors. 1. Amend the 
Chinese name 
and the wording 
in the 
identification. 
2. Based on the 
Chinese 
translation of 
medical terms 
from the 
National 
Academy for 
Educational 
Research and the 
advice of 
experts. 
B.7925 Partial 
thromboplastin 
time tests 2 A partial thromboplastin 
time test is a device used 
for primary screening for 
coagulation abnormalities, 
for evaluation of the effect 
of therapy on procoagulant 
disorders, and as an assay 
for coagulation factor 
deficiencies of the intrinsic 
coagulation pathway B.7925  Partial 
thromboplastin 
time tests 2 A partial thromboplastin 
time test is a device used for 
primary screening for 
coagulation abnormalities, 
for evaluation of the effect 
of therapy on procoagulant 
disorders, and as an assay 
for coagulation factor 
deficiencies of the intrinsic 
coagulation pathway. 1. Amend the 
Chinese name 
and the wording 
in the 
identification. 
2. Based on the 
Chinese 
translation of 
medical terms 
from the 
National 17 
 Academy for 
Educational 
Research and the 
advice of 
experts. 
B.8100 Bothrops atrox 
reagent 2 A Bothrops atrox reagent 
is a device made from 
snake venom and used to 
determine blood 
fibrinogen levels to aid in 
the evaluation of 
disseminated intravascular 
coagulation (nonlocalized 
clotting in the blood 
vessels) in patients 
receiving heparin therapy 
(the administration of the 
anticoagulant heparin in 
the treatment of 
thrombosis) or as an aid in 
the classification of 
dysfibrinogenemia 
(presence in the plasma of 
functionally defective 
fibrinogen). B.8100  Bothrops atrox 
reagent 2 A Bothrops atrox reagent is 
a device made from snake 
venom and used to 
determine blood fibrinogen 
levels to aid in the 
evaluation of disseminated 
intravascular coagulation 
(nonlocalized clotting in the 
blood vessels) in patients 
receiving heparin therapy 
(the administration of the 
anticoagulant heparin in the 
treatment of thrombosis) or 
as an aid in the 
classification of 
dysfibrinogenemia 
(presence in the plasma of 
functionally defective 
fibrinogen). 1. Amend the 
Chinese name 
and the wording 
in the 
identification. 
2. Based on the 
Chinese 
translation of 
medical terms 
from the 
National 
Academy for 
Educational 
Research and the 
advice of 
experts. 18 
 B.8150 Calibrator for cell 
indices 2 A calibrator for cell 
indices is a device that 
approximates whole blood 
or certain blood cells and 
that is used to set an 
instrument intended to 
measure mean cell volume 
(MCV), mean corpuscular 
hemoglobin (MCH), and 
mean corpuscular 
hemoglobin concentration 
(MCHC), or other cell 
indices. It is a suspension 
of particles or cells whose 
size, shape, concentration, 
and other characteristics 
have been precisely and 
accurately determined. B.8150  Calibrator for cell 
indices 2 A calibrator for cell indices 
is a device that 
approximates whole blood 
or certain blood cells and 
that is used to set an 
instrument intended to 
measure mean cell volume 
(MCV), mean corpuscular 
hemoglobin (MCH), and 
mean corpuscular 
hemoglobin concentration 
(MCHC), or other cell 
indices. It is a suspension of 
particles or cells whose size, 
shape, concentration, and 
other characteristics have 
been precisely and 
accurately determined. 1. Amend the 
Chinese name 
and the wording 
in the 
identification. 
2. Based on the 
Chinese 
translation of 
medical terms 
from the 
National 
Academy for 
Educational 
Research and the 
advice of 
experts. 
B.8165 Calibrator for 
hemoglobin or 
hematocrit 
measurement 2 A calibrator for 
hemoglobin or hematocrit 
measurement is a device 
that approximates whole 
blood, red blood cells, or a 
hemoglobin derivative and 
that is used to set 
instruments intended to 
measure hemoglobin, the 
hematocrit, or both. It is a 
material whose 
characteristics have been B.8165  Calibrator for 
hemoglobin or 
hematocrit 
measurement 2 A calibrator for hemoglobin 
or hematocrit measurement 
is a device that 
approximates whole blood, 
red blood cells, or a 
hemoglobin derivative and 
that is used to set 
instruments intended to 
measure hemoglobin, the 
hematocrit, or both. It is a 
material whose 
characteristics have been 1. Amend the 
Chinese name 
and the wording 
in the 
identification. 
2. Based on the 
Chinese 
translation of 
medical terms 
from the 
National 
Academy for 
Educational 19 
 precisely and accurately 
determined. precisely and accurately 
determined. Research and the 
advice of 
experts. 
B.8625 Hematology 
quality control 
mixture 2 A hematology quality 
control mixture is a device 
used to ascertain the 
accuracy and precision of 
manual, semiautomated, 
and automated 
determinations of cell 
parameters such as white 
cell count (WBC), red cell 
count (RBC), platelet 
count (PLT), hemoglobin, 
hematocrit (HCT), mean 
corpuscular volume 
(MCV), mean corpuscular 
hemoglobin (MCH), and 
mean corpuscular 
hemoglobin concentration 
(MCHC). B.8625  Hematology 
quality control 
mixture 2 A hematology quality 
control mixture is a device 
used to ascertain the 
accuracy and precision of 
manual, semiautomat ed, and 
automated determinations of 
cell parameters such as 
white cell count (WBC), red 
cell count (RBC), platelet 
count (PLT), hemoglobin, 
hematocrit (HCT), mean 
corpuscular volume (MCV), 
mean corpuscular 
hemoglobin (MCH), and 
mean corpuscular 
hemoglobin concentration 
(MCHC). 1. Amend the 
Chinese wording   
in the 
identification. 
2. Based on the 
Chinese 
translation of 
medical terms 
from the 
National 
Academy for 
Educational 
Research and the 
advice of 
experts. 
B.8950 Russell viper 
venom reagent 1 Russell viper venom 
reagent is a device used to 
determine the cause of an 
increase in the 
prothrombin time. B.8950  Russell viper 
venom reagent 1 Russell viper venom reagent 
is a device used to 
determine the cause of an 
increase in the prothrombin 
time. 1. Amend the 
Chinese wording 
in the 
identification. 
2. Based on the 
Chinese 
translation of 
medical terms 
from the 20 
 National 
Academy for 
Educational 
Research and the 
advice of 
experts. 
C.3045 In vitro diagnostic 
device for 
Bacillus spp. 
Detection 2 An in vitro diagnostic 
device for Bacillus species 
(spp.) detection is a device 
used to detect and 
differentiate among 
Bacillus spp. and 
presumptively identify B. 
anthracis and other 
Bacillus spp. from cultured 
isolates or clinical 
specimens as an aid in the 
diagnosis of anthrax and 
other diseases caused by 
Bacillus spp. This device 
may consist of Bacillus 
spp. antisera conjugated 
with a fluorescent dye 
(immunofluorescent 
reagents) used to 
presumptively identify 
bacillus-like organisms in 
clinical specimens; 
bacteriophage used for 
differentiating B. anthracis 
from other Bacillus spp.     1. A new 
classification 
number. 
2. Based on the 
U.S. FDA 
regulations. 21 
 based on susceptibility to 
lysis by the phage; or 
antigens used to identify 
antibodies to B. anthracis 
(anti-toxin and anti-
capsular) in serum. 
Bacillus infections include 
anthrax (cutaneous, 
inhalational, or 
gastrointestinal) caused by 
B. anthracis, and 
gastrointestinal disease 
and non-gastrointestinal 
infections caused by B. 
cereus. 
C.3373 Nucleic acid-
based in vitro 
diagnostic devices 
for the detection 
of 
Mycobacterium 
tuberculosis 
complex (MTB-
complex) and the 
genetic mutations 
associated with 
MTB-complex 
antibiotic 
resistance in 
respiratory 
specimens 2 Nucleic acid-based in vitro 
diagnostic devices for the 
detection of 
Mycobacterium 
tuberculosis complex 
(MTB-complex) and the 
genetic mutations 
associated with MTB-
complex antibiotic 
resistance in respiratory 
specimens are qualitative 
nucleic acid-based devices 
that detect the presence of 
MTB-complex-associated 
nucleic acid sequences in 
respiratory samples. These C.3373  Nucleic acid-
based in vitro 
diagnostic devices 
for the detection 
of 
Mycobacterium 
tuberculosis 
complex (MTB-
complex) and the 
genetic mutations 
associated with 
MTB-complex 
antibiotic 
resistance in 
respiratory 
specimens 2 Nucleic acid-based in vitro 
diagnostic devices for the 
detection of Mycobacterium 
tuberculosis complex 
(MTB-complex) and the 
genetic mutations associated 
with MTB-complex 
antibiotic resistance in 
respiratory specimens are 
qualitative nucleic acid-
based devices that detect the 
presence of MTB-complex-
associated nucleic acid 
sequences in respiratory 
samples. These devices are 
intended to aid in the 1.  Amend the 
Chinese wording 
in the 
identification. 22 
 devices are intended to aid 
in the diagnosis of 
pulmonary tuberculosis 
and the selection of an 
initial treatment regimen 
when used in conjunction 
with clinical findings and 
other laboratory results. 
These devices do not 
provide confirmation of 
antibiotic susceptibility 
since other mechanisms of 
resistance may exist that 
may be associated with a 
lack of clinical response to 
treatment other than those 
detected by the device. diagnosis of pulmonary 
tuberculosis and the 
selection of an initial 
treatment regimen when 
used in conjunction with 
clinical findings and other 
laboratory results. These 
devices do not provide 
confirmation of antibiotic 
susceptibility since other 
mechanisms of resistance 
may exist that may be 
associated with a lack of 
clinical response to 
treatment other than those 
detected by the device. 
C.3955 Human 
immunodeficienc
y virus (HIV) 
drug resistance 
genotyping assay 
using next 
generation 
sequencing 
technology 2 The HIV drug resistance 
genotyping assay using 
next generation 
sequencing (NGS) 
technology is an in vitro 
diagnostic device intended 
for use in detecting HIV 
genomic mutations that 
confer resistance to 
specific antiretroviral 
drugs. The device is 
intended to be used as an 
aid in monitoring and 
treating HIV infection.      1. A new 
classification 
number. 
2. Based on the 
U.S. FDA 
regulations. 23 
 C.4520 Immunofluoromet
er equipment 1 Immunofluorometer 
equipment for clinical use 
with its electrical power 
supply is a device used to 
measure the fluorescence 
of fluorochrome-labeled 
antigen-antibody 
complexes. The 
concentration of these 
complexes may be 
measured by means of 
reflected light. A beam of 
light is passed through a 
solution in which a 
fluorochrome has been 
selectively attached to 
serum protein antibody 
molecules in suspension. 
The amount of light 
emitted by the 
fluorochrome label is 
detected by a 
photodetector, which 
converts light energy into 
electrical energy. The 
amount of electrical 
energy registers on a 
readout system such as a 
digital voltmeter or a 
recording chart. This 
electrical readout is called C.4520  Immunofluoromet
er equipment 1 Immunofluorometer 
equipment for clinical use 
with its electrical power 
supply is a device used to 
measure the fluorescence of 
fluorochrome-labeled 
antigen-antibody 
complexes. The 
concentration of these 
complexes may be 
measured by means of 
reflected light. A beam of 
light is passed through a 
solution in which a 
fluorochrome has been 
selectively attached to 
serum protein antibody 
molecules in suspension. 
The amount of light emitted 
by the fluorochrome label is 
detected by a photodetector, 
which converts light energy 
into electrical energy. The 
amount of electrical energy 
registers on a readout 
system such as a digital 
voltmeter or a recording 
chart. This electrical readout 
is called the fluorescence 
value and is used to measure 
the concentration of 1. Amend the 
Chinese wording 
in the 
identification. 
2. Based on the 
Chinese 
translation of 
medical terms 
from the 
National 
Academy for 
Educational 
Research and the 
advice of 
experts. 24 
 the fluorescence value and 
is used to measure the 
concentration of antigen-
antibody complexes. antigen-antibody 
complexes. 
C.5760 Tryptase test 
system 2 A tryptase test system is a 
device that aids in the 
diagnosis of systemic 
mastocytosis. It is intended 
for in vitro diagnostic use 
as an aid in the clinical 
diagnosis of patients with 
a suspicion of systemic 
mastocytosis in 
conjunction with other 
clinical and laboratory 
findings. C.5760  Tryptase test 
system 2 A tryptase test system is a 
device that aids in the 
diagnosis of systemic 
mastocytosis. It is intended 
for in vitro diagnostic use as 
an aid in the clinical 
diagnosis of patients with a 
suspicion of systemic 
mastocytosis in conjunction 
with other clinical and 
laboratory findings. 1. Amend the 
Chinese name 
and the wording 
in the 
identification. 
2. Based on the 
Chinese 
translation of 
medical terms 
from the 
National 
Academy for 
Educational 
Research and the 
advice of 
experts. 
C.5930 Newborn 
screening test 2 A newborn screening test 
for SCID is a device 
intended to measure T-cell 
receptor excision circle 
(TREC) DNA obtained 
from dried blood spot 
specimens on filter paper 
using a polymerase chain 
reaction based test as an 
aid in screening newborns C.5930  Newborn 
screening test  2 A newborn screening test 
for SCID is a device 
intended to measure T-cell 
receptor excision circle 
(TREC) DNA obtained 
from dried blood spot 
specimens on filter paper 
using a polymerase chain 
reaction based test as an aid 
in screening newborns for 1. Amend the 
Chinese name 
and the wording 
in the 
identification. 
2. Based on the 
Chinese 
translation of 
medical terms 
from the 25 
 for SCID. Presumptive 
positive results must be 
followed up by diagnostic 
confirmatory testing. This 
test is not intended for use 
as a diagnostic test, or for 
screening of SCID-like 
syndromes, such as 
DiGeorge syndrome or 
Omenn syndrome. It is 
also not intended to screen 
for less acute SCID 
syndromes, such as leaky 
SCID or variant SCID. SCID. Presumptive positive 
results must be followed up 
by diagnostic confirmatory 
testing. This test is not 
intended for use as a 
diagnostic test, or for 
screening of SCID-like 
syndromes, such as 
DiGeorge syndrome or 
Omenn syndrome. It is also 
not intended to screen for 
less acute SCID syndromes, 
such as leaky SCID or 
variant SCID.  National 
Academy for 
Educational 
Research and the 
advice of 
experts. 
C.5950 Genetic health 
risk assessment 
system 2 A genetic health risk 
assessment system is a 
qualitative in vitro 
molecular diagnostic 
system used for detecting 
variants in genomic 
deoxyribonucleic acid 
(DNA) isolated from 
human specimens that will 
provide information to 
users about their genetic 
risk of developing a 
disease. This device does 
not determine the person's 
overall risk of developing 
a disease. C.5950  Genetic health 
risk assessment 
system 2 A genetic health risk 
assessment system is a 
qualitative in vitro molecular 
diagnostic system used for 
detecting variants in 
genomic deoxyribonucleic 
acid (DNA) isolated from 
human specimens that will 
provide information to users 
about their genetic risk o f 
developing a disease to 
inform lifestyle choices 
and/or conversations with a 
health care professional.  
This device does not 
determine the person's 1. Amend the 
Chinese wording 
in the 
identification. 
2. Revise the text to 
conform to the 
current situation 
of domestic 
management. 
 26 
 overall risk of developing a 
disease. 
D.1100  Arterial blood 
sampling kit 2 An arterial blood sampling 
kit is a device, in kit form, 
used to obtain arterial 
blood samples from a 
patient for blood gas 
determinations. The kit 
may include a syringe, 
needle, cork, and heparin. D.1100  Arterial blood 
sampling kit 1 An arterial blood sampling 
kit is a device, in kit form, 
used to obtain arterial blood 
samples from a patient for 
blood gas determinations. 
The kit may include a 
syringe, needle, cork, and 
heparin. 1. Revise the 
classification. 
2. In view of the  
composition of 
this product 
involving 
“J.5570 
Hypodermic 
single lumen 
needle” and 
“J.5860 Piston 
syringe”, this 
classification 
number is 
changed to Class 
2 with a 2-year 
grace period. 
D.1505  Ventilatory 
electrical 
impedance 
tomograph 2 A ventilatory electrical 
impedance tomograph is a 
non-invasive, non-
radiological ventilatory 
device that provides an 
assessment of local 
impedance variation 
within a cross-section of a 
patient's thorax.      1. A new 
classification 
number. . 
2. Based on the 
U.S. FDA 
regulations. 
G.4780  Intranasal splint 1 An intranasal splint is 
intended to minimize G.4780  Intranasal splint 1 An intranasal splint is 
intended to minimize 1. Amend the 
Chinese name 27 
 bleeding and edema and to 
prevent adhesions between 
the septum and the nasal 
cavity. It is placed in the 
nasal cavity after surgery 
or trauma. The intranasal 
splint is constructed from 
plastic, silicone, or 
absorbent material. bleeding and edema and to 
prevent adhesions between 
the septum and the nasal 
cavity. It is placed in the 
nasal cavity after surgery or 
trauma. The intranasal splint 
is constructed from plastic, 
silicone, or absorbent 
material. and the wording 
in the 
identification. 
H.1520  Gastrointestinal 
Lesion Software 
Detection System  2 A gastrointestinal lesion 
software detection system 
is a computer-assisted 
detection device used in 
conjunction with 
endoscopy for the 
detection of abnormal 
lesions in the 
gastrointestinal tract.  
This device contains 
software to assist in image 
detection and may contain 
hardware to connect to the 
endoscope.     1. A new 
classification 
number. 
2. Based on the 
U.S. FDA 
regulations and 
the current 
situation of the 
domestic 
industry. 
I.4040 Medical apparel 1,2 Surgical apparel are 
devices that are intended 
to be worn by operating 
room personnel during 
surgical procedures to 
protect both the surgical 
patient and the operating 
room personnel from I.4040 Medical apparel 1,2 Surgical apparel are devices 
that are intended to be worn 
by operating room 
personnel during surgical 
procedures to protect both 
the surgical patient and the 
operating room personnel 
from transfer of 1. Amend the 
wording in the 
identification. 
2. In line with the 
Bureau of 
Standards and 
Inspection of the 28 
 transfer of 
microorganisms, body 
fluids, and particulate 
material. Examples 
include surgical caps, 
hoods, masks, gowns, 
operating room shoes and 
shoe covers, and isolation 
masks and gowns. Surgical 
suits and dresses, 
commonly known as scrub 
suits, are excluded.  
Classification: (1) Class 2 
devices intended for 
surgical procedure 
including surgical gowns 
and surgical masks. (2) 
Class 1 other devices. 
Medical masks are 
required to meet 
requirements from the 
national standard CNS 
14774(T5017) or the 
others equivalent 
international standards. 
Masks which are 
claimed/labelled as TN95 
or N95 should meet  TN95 
class (or higher) 
performance requirements 
from disposable dust-proof microorganisms, body 
fluids, and particulate 
material. Examples include 
surgical caps, hoods, masks, 
gowns, operating room 
shoes and shoe covers, and 
isolation masks and gowns. 
Surgical suits and dresses, 
commonly known as scrub 
suits, are excluded. 
Classification: (1) Class 2 
devices intended for 
surgical proocedure  
including surgical gowns 
and surgical masks. (2) 
Class 1 other devices. 
Medical masks are required 
to meet requirements from 
the national standard CNS 
14774(T5017) or the others 
equivalent international 
standards. Masks which are 
claimed/labelled as N95 
should meet  D2 class (or 
higher) performance 
requirements from 
disposable dust-proof masks 
of the national standard 
CNS 14755 (Z2125). 
For medical masks that are 
labelled/claimed to have the Ministry of 
Economic 
Affairs to 
announced the 
revision of CNS 
14774 and CNS 
14755 standards 
on July 15, 2022. 
To facilitate the 
relevant 
industries to  
comply with the 
standards, a 3-
year grace period 
is given. 29 
 masks of the national 
standard CNS 14755 
(Z2125). 
For medical masks that are 
labelled/claimed to have 
the equivalent or above 
effect of TN95 or  N95, the 
sub-micron particulate 
filtration efficiency and  
exhalation/inhalation 
resistance of  airflow  
(replacing “differential 
pressure” test)  of the mask 
should be in accordance 
with TN95 class (or 
higher) performance 
requirements from 
disposable dust-proof 
masks of the national 
standard CNS 14755 
(Z2125).  equivalent or above effect of 
N95, the protection  
efficiency and airflow 
resistance (pressure 
difference during breathing)  
of the mask should be in 
accordance with D2 class 
(or higher) performance 
requirements from 
disposable dust-proof masks 
of the national standard 
CNS 14755 (Z2125). 
I.4450 Nonabsorbable 
gauze for internal 
use 1 Nonabsorbable gauze for 
internal use is a device 
made of an open mesh 
fabric intended to be used 
inside the body or a 
surgical incision or applied 
to internal organs or 
structures, to control 
bleeding, absorb fluid, or 
protect organs or I.4450 Nonabsorbable 
gauze for internal 
use 1 Nonabsorbable gauze for 
internal use is a device 
made of an open mesh 
fabric intended to be used 
inside the body or a surgical 
incision or applied to 
internal organs or structures, 
to control bleeding, absorb 
fluid, or protect organs or 
structures from abrasion, 1. Amend the 
Chinese name 
and the wording 
in the 
identification. 
2. To distinguish 
this classification 
number from 
“I.4490 30 
 structures from abrasion, 
drying, or contamination. 
The device is woven from 
material made of not less 
than 50 percent by mass 
cotton, cellulose, or a 
simple chemical derivative 
of cellulose, and contains 
x-ray detectable elements. drying, or contamination. 
The device is woven from 
material made of not less 
than 50 percent by mass 
cotton, cellulose, or a simple 
chemical derivative of 
cellulose, and contains x- ray 
detectable elements. Absorbable 
hemostatic agent 
and dressing”, 
the identification 
is revised. 
I.4454 Non-absorbable, 
hemostatic gauze 
for temporary 
internal use 2 A non-absorbable , 
hemostatic gauze for 
temporary internal use is a 
device intended to be 
placed temporarily for 
control of severely 
bleeding wounds such as 
surgical wounds and 
traumatic injuries. The 
gauze is coated or 
impregnated with a 
hemostatic material which 
may enhance hemostasis 
by physical means. The 
device is intended to be 
removed once the patient 
is stabilized.      1. A new 
classification 
number. 
2. To distinguish it 
from “I.4490 
Absorbable 
hemostatic agent 
and dressing” , 
the A new 
classification 
number is added.  
I.4800 Manual surgical 
instrument for 
general use 1 A manual surgical 
instrument for general use 
is a nonpowered, hand-
held, or hand-manipulated 
device, either reusable or I.4800 Manual surgical 
instrument for 
general use  1 A manual surgical 
instrument for general use is 
a nonpowered, hand- held, or 
hand-manipulated device, 
either reusable or 1. Amend the 
Chinese wording 
in the 
identification. 31 
 disposable, intended to be 
used in various general 
surgical procedures. The 
device includes the 
applicator, clip applier, 
biopsy brush, manual 
dermabrasion brush, scrub 
brush, cannula, ligature 
carrier, chisel, clamp, 
contractor, curette, cutter, 
dissector, elevator, skin 
graft expander, file, 
forceps, gouge, instrument 
guide, needle guide, 
hammer, hemostat, 
amputation hook, ligature 
passing and knot-tying 
instrument, knife, blood 
lancet, mallet, disposable 
or reusable aspiration and 
injection equipment , 
disposable or reusable 
suturing needle, 
osteotome, pliers, rasp, 
retainer, retractor, saw, 
scalpel blade, scalpel 
handle, one-piece scalpel, 
snare, spatula, stapler, 
disposable or reusable 
stripper, stylet, suturing 
apparatus for the stomach disposable, intended to be 
used in various general 
surgical procedures. The 
device includes the 
applicator, clip applier, 
biopsy brush, manual 
dermabrasion brush, scrub 
brush, cannula, ligature 
carrier, chisel, clamp, 
contractor, curette, cutter, 
dissector, elevator, skin 
graft expander, file, forceps, 
gouge, instrument guide, 
needle guide, hammer, 
hemostat, amputation hook, 
ligature passing and knot-
tying instrument, knife, 
blood lancet, mallet, 
disposable or reusable 
aspiration and injection 
needle , disposable or 
reusable suturing needle, 
osteotome, pliers, rasp, 
retainer, retractor, saw, 
scalpel blade, scalpel 
handle, one-piece scalpel, 
snare, spatula, stapler, 
disposable or reusable 
stripper, stylet, suturing 
apparatus for the stomach 
and intestine, measuring 2. To distinguish it 
from "J.5860 
Piston syringe", 
"J.5570 
Hypodermic 
single lumen 
needle", and 
"J.5430 
Nonelectrically 
powered fluid 
injector", the 
identification is 
revised. 32 
 and intestine, measuring 
tape, and calipers. A 
surgical instrument that 
has specialized uses in a 
specific medical specialty 
is classified in separate 
regulations in parts D 
through P. tape, and calipers. A 
surgical instrument that has 
specialized uses in a specific 
medical specialty is 
classified in separate 
regulations in parts D 
through P. 
J.5150 Nonpowered 
flotation therapy 
mattress 1 A nonpowered flotation 
therapy mattress is a 
mattress intended for 
medical purposes which 
contains air, fluid, or other 
materials that have the 
functionally equivalent 
effect of supporting a 
patient and avoiding 
excess pressure on local 
body areas. The device is 
intended to treat or prevent 
decubitus ulcers (bed 
sores). J.5150 Nonpowered 
flotation therapy 
mattress 1 A nonpowered flotation 
therapy mattress is a 
mattress intended for 
medical purposes which 
contains air, fluid, or other 
materials that have the 
functionally equivalent 
effect of supporting a 
patient and avoiding excess 
pressure on local body 
areas. The device is 
intended to treat or prevent 
decubitus ulcers (bed sores).  1. Amend the 
Chinese name 
and the 
wording in the 
identification. 
    J.6430 Liquid medication 
dispenser 1 A Liquid medication 
dispenser is a device 
intended for medical 
purposes that is used to 
issue a measured amount of 
liquid medication. This product item 
is deleted because 
it has no direct 
medical effect and 
is similar to non-
medical devices 
(such as graduated 
containers). 33 
 J.5780 Medical support 
stocking 2 A medical support 
stocking is a device that is 
constructed of elastic 
material and designed to 
apply controlled pressure 
to the leg, providing 
pressure that gradually 
decreases from the ankle 
upwards  to prevent the 
pooling of blood or 
interstitial fluid  in the legs.  J.5780 Medical support 
stocking 1,2 (a)Medical support stocking 
to prevent the pooling of 
blood in the legs  --
(1)Identification: A medical 
support stocking to prevent 
the pooling of blood in the 
legs is a device  that is 
constructed of elastic 
material and designed to 
apply controlled pressure to 
the leg and that is intended 
for use in the prevention of 
pooling of blood in the 
leg.(2) Classification: Class 
2. 
(b)Medical support stocking 
for general medical 
purposes  --(1)Identification: 
A medical support stocking 
for general medical 
purposes is a device that is 
constructed of elastic 
material and designed to 
apply controlled pressure to 
the leg and that is intended 
for medical purposes other 
than the prevention of 
pooling of blood in the leg. 
(2) Classification: Class 1.  1. Amend  the 
identification 
and the 
classification. 
2. There is no 
difference 
between non-
medical 
devices and 
medical 
devices within 
the scope of the 
Class 1 
devices. 
3. A 2-year grace 
period for 
medical device 
firms to assess  
whether their 
licenses should 
be changed to 
Class 2 or 
cancelled. 
    J.6280 Medical insole 1 A medical insole is a device 
intended for medical This product item 
is deleted  because 34 
 purposes that is placed 
inside a shoe to relieve the 
symptoms of athlete's foot 
infection by absorbing 
moisture. of no differences 
from non-medical 
devices.  
J.6785 Manual patient 
transfer device 1 A manual patient transfer 
device is a device 
consisting of a wheeled 
stretcher and a mechanism 
on which a patient can be 
placed so that the patient 
can be transferred with 
minimal disturbance in a 
horizontal position to the 
stretcher. J.6785 Manual patient 
transfer device 1 A manual patient transfer 
device is a device consisting 
of a wheeled stretcher and a 
mechanism on which a 
patient can be placed so that 
the patient can be 
transferred with minimal 
disturbance in a horizontal 
position to the stretcher. 1. Amend the 
Chinese 
wording in the 
identification. 
 
M.1100  Retinopathy 
detection software 
device  2 A retinopathy detection 
software device is a 
software device that 
incorporates algorithms to 
evaluate ophthalmic 
images for diagnostic 
screening to identify 
retinal diseases or 
conditions.     1. A new 
classification 
number. 
2. Based on the 
U.S. FDA 
regulations and 
the current 
situation of the 
domestic 
industry. 
M.4750  Ophthalmic eye 
shield 1 An ophthalmic eye shield 
is a device that consists of 
a plastic or aluminum eye 
covering intended for 
protection during eye M.4750  Ophthalmic eye 
shield 1 An ophthalmic eye shield is 
a device that consists of a 
plastic or aluminum eye 
covering intended to protect 1. Amend the 
wording in the 
identification to 
distinguish it 35 
 surgery, injury, disease  or 
retain dressing materials in 
place. the eye  or retain dressing 
materials in place. from non-
medical devices.  
M.5844  Corrective 
spectacle lens 1,2 A corrective spectacle lens 
is a glass or plastic device 
that is a lens intended to be 
worn by a patient in a 
spectacle frame to provide 
refractive corrections. The 
device may be modified to 
protect the eyes from 
bright sunlight (i.e., 
corrective sunglasses). 
Corrective sunglass lenses 
may be reflective, tinted, 
polarizing, or 
photosensitized. Products 
made with this corrective 
spectacle lens include 
corrective and protective 
sports goggles, such as 
swimmers’ goggles, ski 
goggles, racquetball eye 
guards, and diving 
goggles. 
Classification: (1) Class1 
(2) Class 2 devices are 
intended to use peripheral 
defocusing technology to 
delay the progression of M.5844  Corrective 
spectacle lens 1 A corrective spectacle lens 
is a glass or plastic device 
that is a lens intended to be 
worn by a patient in a 
spectacle frame to provide 
refractive corrections. The 
device may be modified to 
protect the eyes from bright 
sunlight (i.e., corrective 
sunglasses). Corrective 
sunglass lenses may be 
reflective, tinted, polarizing, 
or photosensitized. Products 
made with this corrective 
spectacle lens include 
corrective and protective 
sports goggles, such as 
swimmers’ goggles, ski 
goggles, racquetball eye 
guards, and diving goggles. 1. Amend  the 
identification 
and the 
classification. 
2. Because 
therapeutic 
lenses are for 
children 
(vulnerable 
groups), poor 
quality or 
improper use 
will accelerate 
the 
deterioration of 
children's 
eyesight and 
cause 
irreversible 
damage. The 
identification 
and the 
classification 
are revised. 
There is a  2-
year grace 
period for the 36 
 myopia or reduce myopia 
in children.  classification 
changes. 
O.0007  Wheelchair 
positioning 
devices 1 A wheelchair positioning 
device is a device intended 
for medical purposes that 
is used with a wheelchair. 
This device is intended as 
an aid in supporting and 
stabilizing patients with 
abnormal muscle tone to 
maintain the sitting 
posture of the wheelchair.  
This device may include:  
1) A  wheelchair backrest 
with conformal rigid base 
and soft cushion. 2) A 
wheelchair positioning 
stand with an adjustable 
mechanical structure that 
is locked on the 
wheelchair or the backrest. 
3) A wheelchair headrest 
system with adjustable 
support height, fore-aft 
position, and angle.      1. A new 
classification 
number. 
2. Based on the 
current 
situation of the 
domestic 
industry. 
O.3490  Truncal orthosis 1 A truncal orthosis is a 
device intended for 
medical purposes to 
support or to immobilize 
fractures, strains, or 
sprains of the neck or O.3490  Truncal orthosis 1 A truncal orthosis is a 
device intended for medical 
purposes to support or to 
immobilize fractures, 
strains, or sprains of the 
neck or trunk of the body . 1. Amend the 
Chinese 
wording in the 
identification. 
2. Based on the 
Chinese 37 
 trunk of the body. 
Examples of truncal 
orthoses are the following: 
Abdominal, cervical, 
cervical-thoracic, lumbar, 
lumbo-sacral, rib fracture, 
sacroiliac, and thoracic 
orthoses and clavicle 
splints.  Examples of truncal 
orthoses are the following: 
Abdominal, cervical, 
cervical-thoracic, lumbar, 
lumbo-sacral, rib fracture, 
sacroiliac, and thoracic 
orthoses and clavicle splints.  translation of 
medical terms 
from the 
National 
Academy for 
Educational 
Research. 
 
O.3640  Arm sling /triangle 
bandage  1 An arm sling /triangle 
bandage  is a device 
intended for medical 
purposes to immobilize or 
bandage up a part of a 
patient's body. This device 
is not elastic. It may 
include the following 
areas: head, chest, arms, 
ankles, hands and knees.  O.3640  Arm sling 1 An arm sling is a device 
intended for medical 
purposes to  immobilize the 
arm, by means of a fabric 
band suspended from 
around the neck.  1. Amend the 
Chinese and 
English names 
and the wording 
in the 
identification. 
2. Based on the 
U.S. FDA 
regulations,  
applicable parts 
of the human 
body are added. 
In addition, to 
distinguish it 
from the 
classification 
number "J.5075 
Elastic 
bandage", it is 
specified that the 
material of this   38 
 product item has 
no elasticity.. 
P.2020 Medical image 
communication 
device 1 A medical image 
communications device 
provides electronic 
transfer of medical image 
data between medical 
devices. It may include a 
physical communications 
medium, modems, and 
interfaces. It may provide 
simple image review 
software functionality for 
medical image processing 
and manipulation, such as 
grayscale window and 
level, zoom and pan, user 
delineated geometric 
measurements, 
compression, or user 
added image annotations. 
The device does not 
perform advanced image 
processing or complex 
quantitative functions. 
This does not include 
electronic transfer of 
medical image software 
functions.  P.2020 Medical image 
communication 
device 1 A medical image 
communications device 
provides electronic transfer 
of medical image data 
between medical devices. It 
may include a physical 
communications medium, 
modems, interfaces, and a 
communications protocol . 1. Amend the 
Chinese name 
and the wording  
in the 
identification. 
2. Based on the 
U.S. FDA 
regulations. 
 39 
 P.2050 Medical image 
management and 
processing system  2 A medical image 
management and 
processing system is a 
device that provides one or 
more capabilities relating 
to the review and digital 
processing of medical 
images for the purposes of 
interpretation by a trained 
practitioner of disease 
detection, diagnosis, or 
patient management. The 
software components may 
provide advanced or 
complex image processing 
functions for image 
manipulation, 
enhancement, or 
quantification that are 
intended for use in the 
interpretation and analysis 
of medical images. 
Advanced image 
manipulation functions 
may include image 
segmentation, 
multimodality image 
registration, or 3D 
visualization. Complex 
quantitative functions may 
include semi -automated P.2050 Picture archiving 
and 
communication  
system 2 A picture archiving and 
communications system is a 
device that provides one or 
more capabilities relating to 
the acceptance, transfer, 
display, storage, and digital 
processing of medical 
images. Its hardware 
components may include 
workstations, digitizers, 
communications devices, 
computers, video monitors, 
magnetic, optical disk, or 
other digital data storage 
devices, and hardcopy 
devices. The software 
components may provide 
functions for performing 
operations related to image 
manipulation, enhancement, 
compression or 
quantification. 1. Amend the 
Chinese and 
English names 
and the 
wording in the 
identification. 
2. Based on the 
U.S. FDA 
regulations 40 
 measurements or time-
series measurements.  
P.2060 Radiological 
Computer-
assisted 
diagnostic 
software for 
lesions suspicious 
of cancer 2 A radiological computer-
assisted diagnostic 
software for lesions 
suspicious of cancer is an 
image processing device 
intended to aid in the 
characterization of lesions 
as suspicious for cancer 
identified on acquired 
medical images such as 
magnetic resonance, 
mammography, 
radiography, or computed 
tomography. The device 
characterizes lesions based 
on features or information 
extracted from the images 
and provides information 
about the lesion(s) to the 
user. Diagnostic and 
patient management 
decisions are made by the 
clinical user.      1. A new 
classification 
number. 
2. Based on the 
U.S. FDA 
regulations and 
the current 
situation of the 
domestic 
industry. 
 
P.2070 Radiological 
Medical image 
analyzer 2 Medical image analyzers, 
including computer-
assisted/aided detection 
(CADe) devices for 
mammography breast 
cancer, ultrasound breast     1. A new 
classification 
number. 
2. Based on the 
U.S. FDA 41 
 lesions, and radiograph 
lung nodules detection, is 
a device that is intended to 
identify, mark, highlight, 
or in any other manner 
direct the clinicians' 
attention to portions of a 
radiology image that may 
reveal abnormalities 
during interpretation of 
patient radiology images 
by the clinicians. This 
device incorporates pattern 
recognition and data 
analysis capabilities and 
operates on previously 
acquired medical images. 
This device is not intended 
to replace the review by a 
qualified radiologist, and 
is not intended to be used 
for triage, or to 
recommend diagnosis.  regulations and 
the current 
situation of the 
domestic 
industry. 
P.2080 Radiological 
computer aided 
triage and 
notification 
software 2 Radiological computer 
aided triage and 
notification software is an 
image processing device 
intended to aid in 
prioritization and triage of 
radiological medical 
images. The device     1. A new 
classification 
number. 
2. Based on the 
U.S. FDA 
regulations and 
the current 
situation of the 42 
 notifies a designated list of 
clinicians of the 
availability of time 
sensitive radiological 
medical images for review 
based on computer aided 
image analysis of those 
images performed by the 
device. The device does 
not mark, highlight, or 
direct users' attention to a 
specific location in the 
original image. The device 
does not remove cases 
from a reading queue. The 
device operates in parallel 
with the standard of care, 
which remains the default 
option for all cases.  domestic 
industry. 
 