General Information for  the Draft  Amendment of 
Annex I to Article 3 and Annex II to Article 4 of the 
“Regulations for Governing the Management of 
Medical Device”  
To ensure the safety of public health, the Food and Drug Administration 
(TFDA) of the Ministry of Health and Welfare (MOHW) intends to amend 
the current “Regulations for Governing the Management of Medical 
Device.” By this amendment, Annex I and Annex II of “Regulations for 
Governing the Management of Medical Device” are modified to represent 
the state of the art of medical device regulation. Classification
NumberClassification
NameClass Identification Classification
NumberClassification
NameClass Identification
A.0002 Clinical
Chemistry
Electrolyte
System1 Clinical chemistry electrolyte system is
intended to perform a specific function in an
assay that is used for the qualitative and/or
quantitative determination of electrolytes and
other ions in a clinical specimen.1. New item.
2. This item is classified into class 1
medical device.
A.1475 Lipoprotein test
system1 A lipoprotein test system is a chemical
analysis  device intended to measure
lipoprotein in serum and plasma. Lipoprotein
measurements are used in the diagnosis and
treatment of lipid disorders (such as diabetes
mellitus), atherosclerosis, and various liver
and renal diseases.A.1475 Lipoprotein test
system1 A lipoprotein test system is a device intended
to measure lipoprotein in serum and plasma.
Lipoprotein measurements are used in the
diagnosis and treatment of lipid disorders
(such as diabetes mellitus), atherosclerosis,
and various liver and renal diseases.1. Amendment of the device identification.
2.This amendment is to clarity the
   identifications of A.1475, C.5580 (Alpha-
   1-lipoprotein immunological test system)
   and C.5600 (Low-density lipoprotein
   immunological test system).
A.1660 Quality control
material
(assayed and
unassayed)1,2 (a) A quality control material (assayed and
unassayed) for clinical chemistry is a device
intended for medical purposes for use in a
test system to estimate test precision and to
detect systematic analytical deviations that
may arise from reagent or analytical
instrument variation. A quality control
material (assayed and unassayed) may be
used for proficiency testing in interlaboratory
surveys. This generic type of device includes
controls (assayed and unassayed) for blood
gases, electrolytes, enzymes, multianalytes
(all kinds), single (specified) analytes, or
urinalysis controls.
(b) Classification: (1) Class 1: The device
does not contain human or animal serum, or
is used for proficiency testing in
interlaboratory surveys. (2) Class 2: The
device contains human or animal serum or is
used for drug abuse detection.A.1660 Quality control
material
(assayed and
unassayed)1,2 (a) A quality control material (assayed and
unassayed) for clinical chemistry is a device
intended for medical purposes for use in a
test system to estimate test precision and to
detect systematic analytical deviations that
may arise from reagent or analytical
instrument variation. A quality control
material (assayed and unassayed) may be
used for proficiency testing in interlaboratory
surveys. This generic type of device includes
controls (assayed and unassayed) for blood
gases, electrolytes, enzymes, multianalytes
(all kinds), single (specified) analytes, or
urinalysis controls.
(b) Classification: (1) Class 1: The device
does not contain human or animal serum, and
is used for proficiency testing in
interlaboratory surveys. (2) Class 2: The
device contains human or animal serum , or
is used for drug abuse detection. (Effective
date: September 1, 2016)1. Amendment of the device identification.(Draft) Amendment of Annex I of the Regulations for Governing the Management of Medical Device
Amended Regulation Current Regulation Description
Page 1 of 17 B.4400 Enzyme
preparations1 Enzyme preparations are products that are
used in the histopathology laboratory for the
following purposes: (1) To disaggregate
tissues and cells already in established
cultures for preparation into subsequent
cultures (e.g., trypsin); (2) To disaggregate
fluid specimens for cytological examination
(e.g., papain for gastric lavage or trypsin for
sputum liquefaction); (3) To aid in the
selective staining of tissue specimens (e.g.,
diastase for glycogen determination).B.4400 Enzyme
preparations1 Enzyme preparations are products that are
used in the histopathology laboratory for the
following purposes: (1) To disaggregate
tissues and cells already in established
cultures for preparation into subsequent
cultures (e.g., trypsin); (2) To disaggregate
fluid specimens for cytological examination
(e.g., papain for gastric lavage or trypsin for
sputum liquefaction); (3) To aid in the
selective staining of tissue specimens (e.g.,
diastase for glycogen determination).1. Amendment of the Chinese
    classification name.
C.3130 Clostridium
difficile toxin
gene
amplification
assay2 A Clostridium difficile toxin gene
amplification assay is a device that consists
of reagents for the amplification and
detection of target sequences in Clostridium
difficile toxin genes in fecal specimens from
patients suspected of having Clostridium
difficile infection (CDI). The detection of
clostridial toxin genes, in conjunction with
other laboratory tests, aids in the clinical
laboratory diagnosis of CDI caused by
Clostridium difficile.1. New item.
C.3365 Multiplex
nucleic acid
assay for
identification of
microorganisms
and resistance
markers from
positive blood
cultures2 A multiplex nucleic acid assay for
identification of microorganisms and
resistance markers from positive blood
cultures is a qualitative in vitro device
intended to simultaneously detect and
identify microorganism nucleic acids from
blood cultures that test positive by Gram
stain or other microbiological stains. The
device detects specific nucleic acid
sequences for microorganism identification
as well as for antimicrobial resistance. This
device aids in the diagnosis of bloodstream
infections when used in conjunction with
other clinical and laboratory findings.
However, the device does not replace
traditional methods for culture and
susceptibility testing.1. New item.
Page 2 of 17 C.3860 Trichomonas
vaginalis nucleic
acid assay2 A Trichomonas vaginalis nucleic acid assay
is a device that consists of primers, probes,
enzymes, and controls for the amplification
and detection of trichomonas nucleic acids in
endocervical swabs, vaginal swabs, and
female urine specimens, from women
symptomatic for vaginitis, cervicitis, or
urethritis and/or to aid in the diagnosis of
trichomoniasis in asymptomatic women. The
detection of trichomonas nucleic acids, in
conjunction with other laboratory tests, aids
in the clinical laboratory diagnosis of
trichomoniasis caused by Trichomonas
vaginalis.1. New item.
C.3990 Gastrointestinal
microorganism
multiplex
nucleic acid-
based assay2 A gastrointestinal microorganism multiplex
nucleic acid-based assay is a qualitative in
vitro diagnostic device intended to
simultaneously detect and identify multiple
gastrointestinal microbial nucleic acids
extracted from human stool specimens. The
device detects specific nucleic acid
sequences for organism identification as well
as for determining the presence of toxin
genes. The detection and identification of a
specific gastrointestinal microbial nucleic
acid from individuals exhibiting signs and
symptoms of gastrointestinal infection aids
in the diagnosis of gastrointestinal infection
when used in conjunction with clinical
evaluation and other laboratory findings. A
gastrointestinal microorganism multiplex
nucleic acid-based assay also aids in the
detection and identification of acute
gastroenteritis in the context of outbreaks.1. New item.
Page 3 of 17 C.5940 Autosomal
recessive carrier
screening gene
mutation
detection system2 Autosomal recessive carrier screening gene
mutation detection system is a qualitative in
vitro molecular diagnostic system used for
genotyping of clinically relevant variants in
genomic DNA isolated from human
specimens intended for prescription use or
over-the-counter use. The device is intended
for autosomal recessive disease carrier
screening in adults of reproductive age. The
device is not intended for copy number
variation, cytogenetic, or biochemical
testing.1. New item.
D.5630 Nebulizer 2 A nebulizer is a device intended to spray
liquids in aerosol form into gases that are
delivered to lower respiratory tract of  the
patient. This device may contain a baffle to
generate homogenious downsized aerosol.
Heated, ultrasonic, gas, venturi, and
refillable nebulizers are included in this
generic type of device.D.5630 Nebulizer 2 A nebulizer is a device intended to spray
liquids in aerosol form into gases that are
delivered directly  to the patient for breathing .
Heated, ultrasonic, gas, venturi, and refillable
nebulizers are included in this generic type of
device.1. Amendment of the device identification.
2. This amendment is to clarity the
    identifications of D.5630 (Nebulizer) and
    D.5640 (Medicinal nonventilatory
    nebulizer (atomizer)).
D.5640 Medicinal
nonventilatory
nebulizer
(atomizer)1 A medicinal nonventilatory nebulizer
(atomizer) is a device that is intended to
spray liquid medication in aerosol form that
are delivered to upper respiratory tract of the
patient .D.5640 Medicinal
nonventilatory
nebulizer
(atomizer)1 A medicinal nonventilatory nebulizer
(atomizer) is a device that is intended to
spray liquid medication in aerosol form into
the air that a patient will breathe .1. Amendment of the device identification.
2. This amendment is to clarity the
    identifications of D.5630 (Nebulizer) and
    D.5640 (Medicinal nonventilatory
    nebulizer (atomizer)).
D.5895 Continuous
ventilator and
accessories2 A continuous ventilator (respirator) and
accessories  is a device intended to
mechanically control or assist patient
breathing by delivering a predetermined
percentage of oxygen in the breathing gas.
Adult, pediatric, and neonatal ventilators are
included in this generic type of device. Face
masks intended to be used with continuous
ventilators are included in this classification.D.5895 Continuous
ventilator2 A continuous ventilator (respirator) is a
device intended to mechanically control or
assist patient breathing by delivering a
predetermined percentage of oxygen in the
breathing gas. Adult, pediatric, and neonatal
ventilators are included in this generic type
of device.1. Amendment of the device name and the
   device identification.
2. Face masks intended to be used with
    continuous ventilators are included in this
    classification.
Page 4 of 17 2,3 Percutaneous
transluminal
coronary
angioplasty
(PTCA) catheterE.0005 E.0005 Percutaneous
transluminal
coronary
angioplasty
catheter3 A percutaneous transluminal coronary
angioplasty catheter is a device used in
Percutaneous Transluminal Coronary
Angioplasty (PTCA) surgery. The device
contains one or multiple balloon which is/are
inflated and deflated by hydraulic or air
pressure, and is intended to improve
myocardial perfusion in coronary ischemia
area. It contains a type of radiographic
marker to facilitate fluoroscopic visualization
of the balloon during use.1. Amendement of the device identification
    and the device class.(a) Standard PTCA catheter (1)
Identification: A PTCA catheter is a device
that operates on the principle of hydraulic
pressurization applied through an inflatable
balloon attached to the distal end. A PTCA
balloon catheter has a single or double lumen
shaft. The catheter features a balloon of
appropriate compliance for the clinical
application, constructed from a polymer. The
balloon is designed to uniformly expand to a
specified diameter and length at a specific
pressure as labeled, with well characterized
rates of inflation and deflation and a defined
burst pressure. The device generally features
a type of radiographic marker to facilitate
fluoroscopic visualization of the balloon
during use. A PTCA catheter is intended for
balloon dilatation of a hemodynamically
significant coronary artery or bypass graft
stenosis in patients evidencing coronary
ischemia for the purpose of improving
myocardial perfusion. A PTCA catheter may
also be intended for the treatment of acute
myocardial infarction; treatment of in-stent
restenosis (ISR) and/or post-deployment
stent expansion. (2) Classification: Class 2.
(b) Cutting/scoring PTCA catheter (1)
Identification: A cutting/scoring PTCA
catheter is a balloon-tipped catheter with
cutting/scoring elements attached, which is
used in those circumstances where a high
pressure balloon resistant lesion is
encountered. A cutting/scoring PTCA
catheter is intended for the treatment of
hemodynamically significant coronary artery
stenosis for the purpose of improving
myocardial perfusion. A cutting/scoring
PTCA catheter may also be indicated for use
in complex type C lesions or for the
treatment of in-stent restenosis. (2)
Classification: Class 3.
Page 5 of 17 E.0006 Endovascular
graft system3 An endovascular graft system is a device
partially or completely placed in the human
or artificial blood vessels. This device is
intended for the revision of arteriovenous
access circuits to maintain or re-establish
vascular access. This device is deployed
through the vessel circuit. Endovascular graft
systems for aortic aneurysm treatment and
arteriovenous (AV) dialysis access circuit
stenosis treatment are included in this
classification.E.0006 Aortic aneurysm
treatment
endovascular
graft system3 1. Amendment of the device name and the
   device identification.
E.0008 Percutaneous
cardiac ablation
system2,3 A percutaneous cardiac ablation system is
intended for cardiac ablation surgery. This
system contains percutaneous cardiac
ablation catheter, RF ablation generator,
cryoablation system, cooling catheter and
cooling pump. Catheter remote control
system is not included in this classification.
Classification: (1) Class 2: RF ablation
generator, cryoablation system, cooling
catheter and cooling pump. (2) Class 3:
percutaneous cardiac ablation catheter.1. New item.
E.1415 Coronary
vascular
physiologic
simulation
software device2 A coronary vascular physiologic simulation
software device is a prescription device that
provides simulated functional assessment of
blood flow in the coronary vascular system
using data extracted from medical device
imaging to solve algorithms and yield
simulated metrics of physiologic information
(e.g., blood flow, coronary flow reserve,
fractional flow reserve, myocardial
perfusion). A coronary vascular physiologic
simulation software device is intended to
generate results for use and review by a
qualified clinician.1. New item.
E.2370 Electrocardio-
graph surface
electrode tester2 An electrocardiograph surface electrode
tester is a device used to test the function and
application of electrocardiograph electrodes.1. Deleted item.
2. This device is excluded from the medical
    device regulation.
Page 6 of 17 E.3640 Indirect
pacemaker
generator
function
analyzer2 An indirect pacemaker generator function
analyzer is an electrically powered device
that is used to determine pacemaker function
or pacemaker battery function by periodically
monitoring an implanted pacemaker's pulse
rate and pulse width. The device is
noninvasive, and it detects pacemaker pulse
rate and width via external electrodes in
contact with the patient's skin.1. Deleted item.
2. This device is excluded from the medical
    device regulation.
E.4100 Extracorporeal
circuit and
accessories for
long-term
respiratory/cardi
opulmonary
failure2 An extracorporeal circuit and accessories for
long-term respiratory/cardiopulmonary
support (>6 hours) is a system of devices and
accessories that provides assisted
extracorporeal circulation and physiologic
gas exchange of the patient's blood in
patients with acute respiratory failure or
acute cardiopulmonary failure, where other
available treatment options have failed, and
continued clinical deterioration is expected
or the risk of death is imminent. The main
devices and accessories of the system
include, but are not limited to, the console
(hardware), software, and disposables,
including, but not limited to, an oxygenator,
blood pump, heat exchanger, cannulae,
tubing, filters, and other accessories (e.g.,
monitors, detectors, sensors, connectors).1. New item.
E.5700 Steerable
cardiac ablation
catheter remote
control system2 A steerable cardiac ablation catheter remote
control system is a prescription device that is
external to the body and interacts with the
manual handle of a steerable cardiac ablation
catheter to remotely control the
advancement, retraction, rotation, and
deflection of a compatible, steerable ablation
catheter used for the treatment of cardiac
arrhythmias in the right side of the heart. The
device allows reversion to manual control of
the steerable cardiac ablation catheter
without withdrawal of the catheter and
interruption of the procedure.1. New item.
Page 7 of 17 E.5910 Esophageal
thermal
regulation
device2 An esophageal thermal regulation device is a
prescription device used to apply a specified
temperature to the endoluminal surface of
the esophagus via an external controller.
This device may incorporate a mechanism
for gastric decompression and suctioning.
The device is used to regulate patient
temperature.1. New item.
F.5525 Preformed tooth
positioner1 A preformed tooth positioner is a plastic
device that is made for  an impression of a
bite intended to prevent a patient's teeth from
shifting position or to maintain  teeth in a
final position after orthodontic appliances
(braces) have been removed. The patient
bites down on the device for several hours a
day to stabilize  the position of the teeth .F.5525 Preformed tooth
positioner1 A preformed tooth positioner is a plastic
device that is an impression of a perfected
bite intended to prevent a patient's teeth from
shifting position or to move  teeth to a final
position after orthodontic appliances (braces)
have been removed. The patient bites down
on the device for several hours a day to force
the teeth into a final  position or to maintain
the teeth in their corrected position .1. Amendment of the device name and the
device identification.
F.5560 Electrical
salivary
stimulatory
system2 An electrical salivary stimulatory system is a
prescription intraoral device that is intended
to electrically stimulate a relative increase in
saliva production.1. New item.
G.3315 Tympanic
membrane
contact hearing
aid2 A tympanic membrane contact hearing aid is
a prescription device that compensates for
impaired hearing. Amplified sound is
transmitted by vibrating the tympanic
membrane through a transducer that is in
direct contact with the tympanic membrane.1. New item.
Page 8 of 17 H.1075 Gastroenterolog
y-urology biopsy
instrument1,2 (a) A gastroenterology-urology biopsy
instrument is a device used to remove, by
cutting or aspiration, a specimen of tissue for
microscopic examination. This generic type
of device includes the biopsy punch,
gastrointestinal mechanical biopsy
instrument, suction biopsy instrument,
gastro-urology biopsy needle and needle set,
and nonelectric biopsy forceps. This section
does not apply to biopsy instruments that
have been used  in other medical specialty
areas or covered by biopsy instruments of
relevant classification categories .
(b) Classification: (1) Class 2, (2) Class 1 for
the biopsy forceps cover and the non-electric
biopsy forceps.H.1075 Gastroenterolog
y-urology
biopsy
instrument1,2 (a) A gastroenterology-urology biopsy
instrument is a device used to remove, by
cutting or aspiration, a specimen of tissue for
microscopic examination. This generic type
of device includes the biopsy punch,
gastrointestinal mechanical biopsy
instrument, suction biopsy instrument,
gastro-urology biopsy needle and needle set,
and nonelectric biopsy forceps. This section
does not apply to biopsy instruments that
have specialized uses in other medical
specialty areas and that are covered by
classification regulations in other parts of the
device classification regulations .
(b) Classification: (1) Class 2, (2) Class 1 for
the biopsy forceps cover and the non-electric
biopsy forceps.1. Amendment of the device identification.
H.1500 Endoscope and
accessories1,2 (a) An endoscope and accessories is a device
used to provide access, illumination, and
allow observation or manipulation of body
cavities, hollow organs, and canals. The
device consists of various rigid or flexible
instruments that are inserted into body
spaces and may include an optical system for
conveying an image to the user's eye and
their accessories may assist in gaining access
or increase the versatility and augment the
capabilities of the devices. Examples of
devices that are within this generic type of
device include cleaning accessories for
endoscopes, photographic accessories for
endoscopes, nonpowered anoscopes,
binolcular attachments for endoscopes,
pocket battery boxes, flexible or rigid
choledochoscopes, colonoscopes, diagnostic
cystoscopes, cystourethroscopes,
enteroscopes,
esophagogastroduodenoscopes, rigid
esophagoscopes, fiberoptic illuminators for
endoscopes, incandescent endoscope lamps,
biliary pancreatoscopes, proctoscopes,
resectoscopes, nephroscopes,
sigmoidoscopes, ureteroscopes,H.1500 Endoscope and
accessories1,2 (a) An endoscope and accessories is a device
used to provide access, illumination, and
allow observation or manipulation of body
cavities, hollow organs, and canals. The
device consists of various rigid or flexible
instruments that are inserted into body spaces
and may include an optical system for
conveying an image to the user's eye and
their accessories may assist in gaining access
or increase the versatility and augment the
capabilities of the devices. Examples of
devices that are within this generic type of
device include cleaning accessories for
endoscopes, photographic accessories for
endoscopes, nonpowered anoscopes,
binolcular attachments for endoscopes,
pocket battery boxes, flexible or rigid
choledochoscopes, colonoscopes, diagnostic
cystoscopes, cystourethroscopes,
enteroscopes, esophagogastroduodenoscopes,
rigid esophagoscopes, fiberoptic illuminators
for endoscopes, incandescent endoscope
lamps, biliary pancreatoscopes, proctoscopes,
resectoscopes, nephroscopes,
sigmoidoscopes, ureteroscopes,
urethroscopes, endomagnetic retrievers,1. Amendment of the device identification.
Page 9 of 17 H.2050 Prostate lesion
documentation
system2 A prostate lesion documentation system is a
prescription device intended for use in
producing an image of the prostate as an aid
in documenting prostate abnormalities
previously identified during a digital rectal
examination. The device uses pressure
sensors and image reconstruction software to
produce a prostate image that highlights
regional differences in intraprostatic tissue
elasticity or stiffness. The device is limited
to use as a documentation tool and is not
intended for diagnostic purposes or for
influencing any clinical decisions.1. New item.
H.5025 Vibrator for
climax control
of premature
ejaculation2 A vibrator for climax control of premature
ejaculation is used for males who suffer from
premature ejaculation. It is designed to
increase the time between arousal and
ejaculation using the stimulating vibratory
effects of the device on the penis.1. New item.sigmoidoscopes, ureteroscopes,
urethroscopes, endomagnetic retrievers,
cytology brushes for endoscopes, biopsy
tissue forceps used with endoscopes, and
lubricating jelly for transurethral surgical
instruments. This section does not apply to
endoscopes that have been used  in other
medical specialty areas or covered by
endoscopes of relevant classification
categories .
(b) Classification: (1) Class 2. (2) Class 1 for
the photographic accessories for endoscope,
miscellaneous bulb adapter for endoscope,
binocular attachment for endoscope,
eyepiece attachment for prescription lens,
teaching attachment, inflation bulb,
measuring device for panendoscope,
photographic equipment for physiologic
function monitor, special lens instrument for
endoscope, smoke removal tube,
rechargeable battery box, pocket battery box,
bite block for endoscope, and cleaning brush
for endoscope.urethroscopes, endomagnetic retrievers,
cytology brushes for endoscopes, and
lubricating jelly for transurethral surgical
instruments. This section does not apply to
endoscopes that have specialized uses in
other medical specialty areas and that are
covered by classification regulations in other
parts of the device classification regulations .
(b) Classification: (1) Class 2. (2) Class 1 for
the photographic accessories for endoscope,
miscellaneous bulb adapter for endoscope,
binocular attachment for endoscope, eyepiece
attachment for prescription lens, teaching
attachment, inflation bulb, measuring device
for panendoscope, photographic equipment
for physiologic function monitor, special lens
instrument for endoscope, smoke removal
tube, rechargeable battery box, pocket battery
box, bite block for endoscope, and cleaning
brush for endoscope.
Page 10 of 17 H.5140 Urethral insert
with pump for
bladder drainage2 A urethral insert with pump for bladder
drainage is a catheter-like device with
internal pump mechanism that is placed in
the urethra. Under patient control the internal
pump draws urine out of the bladder when
voiding is desired, and blocks urine flow
when continence is desired. The device is
intended for use by women who cannot
empty their bladder due to impaired detrusor
contractility.1. New item.
H.5930 Rectal control
system2 A rectal control system is a prescription
device intended to treat fecal incontinence by
controlling the size of the rectal lumen. The
device is inserted in the vagina and includes
a portion that expands to reduce the rectal
lumen to prevent stool leakage and retracts
to allow normal passage of stool. The device
includes an external regulator to control the
state of expansion.1. New item.
I.0001 High density
electrical current
subcutaneous
wrinkle
reduction device2 A device with high density electrical current
for subcutaneous wrinkle reduction is a
device applying an electrical current to
electrodes on a patient's skin up to subdermal
or muscle layers for reducing body wrinkles
and connective tissue swelling by physical
action. This device applies high density
electrical current to stimulate collagen and
elastin production by heating tissues in the
deep layers of the skin.I.0001 Subcutaneous
electrical
wrinkle
reduction device2 1. Amendment of the device
   name and the device identification.
I.0003 Ultrasonic
surgical
instrument2 An ultrasonic surgical instrument is a
surgical device for soft tissue ablation. This
device contains ultrasound generator and
accessories including control console,
ultrasound applicator(s), foot switch, and
waste collector.I.0003 Ultrasonic
surgical
instrument2 1. Amendment of the device identification.
Page 11 of 17 I.0008 Transcutaneous
skin stimulator2 A transcutaneous skin stimulator applies
energy (e.g., electrical current, optical energy
or ultrasound energy) on a patient's skin up
to dermal or subdermal layers to modify skin
appearance (e.g., skin tightening, toning,
lifting or reducing wrinkles) or to stimulate
collagen or cell production.1. New item.
I.0009 High Intensity
Focused
Ultrasound
(HIFU) Ablation
System3 An high intensity focused ultrasound (HIFU)
ablation system is intended to use HIFU to
ablate soft tissue or specific cell tissue. The
system needs to be used with medical
imaging systems (e.g., MR imaging systems)
used for guiding the procedure.1. New item.
I.4360 Scalp cooling
system to reduce
the likelihood of
chemotherapy-
induced alopecia2 A scalp cooling system to reduce the
likelihood of chemotherapy-induced alopecia
is a prescription device intended to reduce
the frequency and severity of alopecia during
chemotherapy in which alopecia-inducing
chemotherapeutic agents are used.1. New item.
I.4370 Surgical drape
and drape
accessories1,2(a) A surgical drape and drape accessories is
a device made of natural or synthetic
materials intended to be used as a protective
patient covering, such as to isolate a site of
surgical incision from microbial and other
contamination. The device includes a plastic
wound protector that may adhere to the skin
around a surgical incision or be placed in a
wound to cover its exposed edges, and a
latex drape with a self-retaining finger cot
that is intended to allow repeated insertion of
the surgeon's finger into the rectum during
performance of a transurethral
prostatectomy. (b) Classification: (1) Class
2. (2) Class 1 for drape and cover intended
for medical device covering.I.4370 Surgical drape
and drape
accessories2 A surgical drape and drape accessories is a
device made of natural or synthetic materials
intended to be used as a protective patient
covering, such as to isolate a site of surgical
incision from microbial and other
contamination. The device includes a plastic
wound protector that may adhere to the skin
around a surgical incision or be placed in a
wound to cover its exposed edges, and a
latex drape with a self-retaining finger cot
that is intended to allow repeated insertion of
the surgeon's finger into the rectum during
performance of a transurethral prostatectomy.1. Amendment of the device class, the
    device identification and the Chinese
    device name.
2. For devices originally classified as class 2
    devices and now reclassified as class 1
    devices, the license holder shall obtain a
    new class 1 medical device license
    before such devices can be put on the
    market.
Page 12 of 17 I.4670 Internal tissue
marker2 An internal tissue marker is a prescription
use device that is intended for use prior to or
during general surgical procedures to
demarcate selected sites on internal tissues.1. New item.
J.6600 Ultraviolet (UV)
radiation
chamber
disinfection
device2 An ultraviolet (UV) radiation chamber
disinfection device is intended for the low-
level surface disinfection of non-porous
equipment surfaces by dose-controlled UV
irradiation. This classification does not
include self-contained open chamber UV
radiation disinfection devices intended for
whole room disinfection in a health care
environment.1. New item.
J.6991 Medical washer 2 A medical washer is a device that is intended
for general medical purposes to clean
surgical instruments, anesthesia equipment,
hollowware, and other medical devices.J.6991 Medical washer 2 A medical washer is a device that is intended
for general medical purposes to clean and dry
surgical instruments, anesthesia equipment,
hollowware, and other medical devices.1. Amendement of the device identification.
2. Devices only intended to dry other
    medical devices are excluded from the
    medical device regulation.
K.1410 Electroencephal
ograph
electrode/lead
tester1 An electroencephalograph electrode/lead
tester is a device used for testing the
impedance (resistance to alternating current)
of the electrode and lead system of an
electroencephalograph to assure that an
adequate contact is made between the
electrode and the skin.1. Deleted item.
2. This device is excluded from the medical
    device regulation.
K.1430 Electroencephal
ograph test
signal generator1 An electroencephalograph test signal
generator is a device used to test or calibrate
an electroencephalograph.1. Deleted item.
2. This device is excluded from the
    medical device regulation.
Page 13 of 17 K.5880 Implanted spinal
cord stimulator
for bladder
evacuation2,3(a) An implanted spinal cord stimulator for
bladder evacuation is an electrical stimulator
used to empty the bladder of a paraplegic
patient who has a complete transection of the
spinal cord and who is unable to empty his
or her bladder by reflex means or by the
intermittent use of catheters. The stimulator
consists of an implanted receiver with
electrodes that are placed on the conus
medullaris portion of the patient's spinal cord
and an external transmitter for transmitting
the stimulating pulses across the patient's
skin to the implanted receiver. (b)
Classification: (1) Class 2 for devices
intended to treat body/limbs cronical or
intractable pain, (2) Class 3 for other devices
(e.g., intended to treat pain caused from
failed back surgery syndrome).K.5880 Implanted spinal
cord stimulator
for bladder
evacuation.2 An implanted spinal cord stimulator for
bladder evacuation is an electrical stimulator
used to empty the bladder of a paraplegic
patient who has a complete transection of the
spinal cord and who is unable to empty his or
her bladder by reflex means or by the
intermittent use of catheters. The stimulator
consists of an implanted receiver with
electrodes that are placed on the conus
medullaris portion of the patient's spinal cord
and an external transmitter for transmitting
the stimulating pulses across the patient's
skin to the implanted receiver.1.Amendement of the device class
   and the device identification.
L.5980 Surgical mesh
for transvaginal
pelvic organ
prolapse repair3 Surgical mesh for transvaginal pelvic organ
prolapse repair is a prescription device
intended to reinforce soft tissue in the pelvic
floor. This device is a porous implant that is
made of synthetic material, non-synthetic
material, or a combination of synthetic and
non-synthetic materials.1. New item.
L.6165 Intravaginal
culture system2 An intravaginal culture system is a
prescription device intended for preparing,
holding, and transferring human gametes or
embryos during intravaginal in vitro
fertilization or intravaginal culture
procedures.1. New item.
M.0002 Endocapsular
ring3 An endocapsular ring is an ophthalmic
device for placement into the capsular bag. It
may be used for the stabilization of lens
capsular bag when zonules are broken or
missing. Examples are capsular tension
rings.1. New item.
Page 14 of 17 M.5905 Oral electronic
vision aid2 An oral electronic vision aid is a battery-
powered prescription device that contains an
electrode stimulation array to generate
electrotactile stimulation patterns that are
derived from digital object images captured
by a camera. It is intended to aid profoundly
blind patients in orientation, mobility, and
object recognition as an adjunctive device to
other assistive methods such as a white cane
or a guide dog.1. New item.
2,3 (a) Pedicle screw spinal systems are multiple
component devices, made from a variety of
materials, including alloys such as 316L
stainless steel, 316LVM stainless steel, 22Cr-
13Ni-5Mn stainless steel, Ti-6Al-4V, and
unalloyed titanium, that allow the surgeon to
build an implant system to fit the patient's
anatomical and physiological requirements.
Such a spinal implant assembly consists of a
combination of anchors (e.g., bolts, hooks,
and/or screws); interconnection mechanisms
incorporating nuts, screws, sleeves, or bolts;
longitudinal members (e.g., plates, rods,
and/or plate/rod combinations); and/or
transverse connectors.
(b) Classification: Type 2  for devices that
comply with the following listed special
controls (comply with material standards,
comply with mechanical testing standards,
and comply with biocompatibility standards).
Type 3  for pedicle screw spinal systems
intended for other purposes.1. Correction of text. 2,3 Pedicle screw
spinal systemN.3070 N.3070 Pedicle screw
spinal system(a) Pedicle screw spinal systems are multiple
component devices, made from a variety of
materials, including alloys such as 316L
stainless steel, 316LVM stainless steel,
22Cr-13Ni-5Mn stainless steel, Ti-6Al-4V,
and unalloyed titanium, that allow the
surgeon to build an implant system to fit the
patient's anatomical and physiological
requirements. Such a spinal implant
assembly consists of a combination of
anchors (e.g., bolts, hooks, and/or screws);
interconnection mechanisms incorporating
nuts, screws, sleeves, or bolts; longitudinal
members (e.g., plates, rods, and/or plate/rod
combinations); and/or transverse connectors.
(b) Classification: (1) Class 2  for devices
that comply with the following listed special
controls (comply with material standards,
comply with mechanical testing standards,
and comply with biocompatibility standards).
(2) Class 3  for pedicle screw spinal systems
intended for other purposes.
Page 15 of 17 O.3480 Powered lower
extremity
exoskeleton2 A powered lower extremity exoskeleton is a
prescription device that is composed of an
external, powered, motorized orthosis that is
placed over a person's paralyzed or
weakened limbs for medical purposes.1. New item.
O.5525 Iontophoresis
device2 (a) Iontophoresis device intended for certain
specified uses - Identification : An
iontophoresis device is intended for use in
the diagnosis of cystic fibrosis or is used
along with certain drugs to achieve specific
functions. This device uses a current to
introduce ions of soluble salts or certain
drugs into the patient's body for inducing
sweating. This device collects patient's sweat
and determines its composition and weight
to diagnose cystic fibrosis.  Classification:
Class 2.
(b) Iontophoresis device intended for any
other purposes - Identification: An
iontophoresis device intended for certain
specified uses other than those referred to in
paragraph (a) above. This device uses a
current to introduce ions of drugs or non-
drug solutions into the patient's body for
achieving specific medical purposes.
Classification: Class 2.O.5525 Iontophoresis
device2,3(a) Iontophoresis device intended for certain
specified uses. (1) Identification . An
iontophoresis device is a device that is
intended to use a direct current  to introduce
ions of soluble salts or other drugs into the
body and induce sweating for use in the
diagnosis of cystic fibrosis or for other uses
(if the labeling of the drug intended for use
with the device bears adequate directions for
the device's use with that drug). When used
in the diagnosis of cystic fibrosis, the sweat
is collected and its composition and weight
are determined. (2) Classification: Class 2.
(b) Iontophoresis device intended for any
other purposes - (1) Identification: An
iontophoresis device intended for any other
purposes is a device that is intended to use a
direct current to introduce ions of drugs or
non-drug solutions into the body for medical
purposes other than those specified in
paragraph (a) of this section. (2)
Classification: Class 3.1. Amendment of the device identification
    and the device class.
Page 16 of 17 Classification
NumberClassification Name Class Classification
NumberClassification Name Class
I.4370 Surgical drape and drape
accessories1 1. New item.
2. The manufacturing of drape and cover intended for medical device covering
    shall comply with the provisions of Essential Mode in Part 3, Chapter 3 of
    the Pharmaceutical Good Manufacturing Practice Regulations.(Draft) Amendment of Annex II of the Regulations for Governing the Management of Medical Device
Amended Regulation Current Regulation
Description
Page 17 of 17