Page 1 of 10  
 General information fot the Draft Amendment of 
Annex I to Article 3 and Article 8 of “The 
Regulations for Governing the Management of 
Medical Device” 
Regarding to the wide range of scientific fields involved in medical 
equipment and variety of device types, items and components involved 
with rapid technological innovation, this notice is amending the contents of  
annex I to article 3 of “The Regulations for Governing the Management of 
Medical Device.” In order to clarify the classification description, intended 
use situations and to harmonize with international regulatory trends to in 
line with the current situation, the regulation is to be amended. Considering 
a transition period is necessary for manufactures to comply with the new 
requirements, the contents of article 8 of the regulation is amended 
accordingly.  Page 2 of 10  
 (Draft)Amendment of article 8 of “The 
Regulations for Governing the Management of 
Medical Device” 
Amended Article Current Article Description 
Article 8  
The regulations shall be 
implemented on the date 
of announcement, except 
the manufacturing of 
Optical Impression 
Systems for CAD/CAM 
(Classification Number: 
F.3661) under the 
amendment of Article 3 
Item 2 Annex 1 on January 
7th, 2014, shall comply 
with this regulation from 
July 1st, 2014. 
 
The manufacturing of 
Quality Control Material 
(assayed and unassayed) 
(Classification Number: 
A.1660), Ear, Nose, and 
Throat Drug 
Administration Device 
(Classification Number: 
G.5220), and Corrective 
Spectacle Lens 
(Classification Number: 
M.5844) under the 
amendment of Article 3 
Item 2 Annex 1 on June 
3rd, 2015, shall comply 
with this regulation from Article 8  
The regulations shall be 
implemented on the date 
of announcement, except 
the manufacturing of 
Optical Impression 
Systems for CAD/CAM 
(Classification Number: 
F.3661) under the 
amendment of Article 3 
Item 2 Annex 1 on January 
7th, 2014, shall comply 
with this regulation from 
July 1st, 2014. 
 
The manufacturing of 
Quality Control Material 
(assayed and unassayed) 
(Classification Number: 
A.1660), Ear, Nose, and 
Throat Drug 
Administration Device 
(Classification Number: 
G.5220), and Corrective 
Spectacle Lens 
(Classification Number: 
M.5844) under the 
amendment of Article 3 
Item 2 Annex 1 on June 
3rd, 2015, shall comply 
with this regulation from Regarding to the 
implementation date of 
Rapid Screening System 
for Influenza Virus 
Antigen (Classification 
Number: C.3328), 
Surgical Gloves 
(Classification Number: 
I.4460), Patient 
Examination Gloves 
(Classification Number: J. 
6250)" and Mechanical 
Wheelchair (Classification 
Number: O. 3850) under 
the amendment of Article 
3 Item 2 Annex 1 on 
January 1st, 2019, the 
amendments should be 
implanted one year after 
the official announcement. 
Therefore the 
manufacturers can have 
sufficient time to comply 
with the regulations. Page 3 of 10  
 September 1st, 2016. 
 
The manufacturing of 
Rapid Screening System 
for Influenza Virus 
Antigen (Classification 
Number: C.3328), 
Surgical Gloves 
(Classification Number: 
I.4460), Patient 
Examination Gloves 
(Classification Number: J. 
6250)" and Mechanical 
Wheelchair (Classification 
Number: O. 3850) under 
the amendment of Article 
3 Item 2 Annex 1 on 2019, 
shall comply with this 
regulation from 2020. 
 September 1st, 2016. Page 4 of 10  
 (Draft)Amendment of Annex 1 to Article 3 of “The Regulations for Governing the 
Management of Medical Device” 
Amended regulation Current regulation 
Description Classification   
number Classification 
name Class Description Classification   
number Classification 
name Class Description 
C.3328 Influenza virus 
antigen 
detection test 
system. 2 An influenza virus antigen detection 
test system is a device for 
qualitative (rapid screening) 
detection of influenza virus 
infection directly from clinical 
specimens of patients with 
respiratory symptoms and signs.  
The test aids in the diagnosis of 
influenza infection and provides 
epidemiological information on 
influenza. Due to the propensity of 
the virus to mutate, new strains 
emerge over time which may 
potentially affect the performance 
of these devices. Because influenza 
is highly contagious and may lead 
to an acute respiratory tract 
infection causing severe ill ness and 
even death, the accuracy of these 
devices has serious public health 
implications.         1. New classification. 
2. Reference to US FDA 
2017 new regulation 
number (866.3328). Page 5 of 10  
 Amended regulation Current regulation 
Description Classification   
number Classification 
name Class Description Classification   
number Classification 
name Class Description 
C.3330 Influenza virus 
serological 
reagents. 1 Influenza virus serological reagents 
are devices that consist of antigens 
and antisera used in serological tests 
to identify antibodies to influenza in 
serum. The identification aids in the 
diagnosis of influenza (flu) and 
provides epidemiological 
information on influenza. Influenza 
is an acute respiratory tract disease, 
which is often epidemic. This 
classification does not include 
devices for qualitative (rapid 
screening) detection of influenza 
virus infection directly from clinical 
specimens of patients with 
respiratory symptoms and signs. C.3330 Influenza virus 
serological 
reagents. 1 Influenza virus serological reagents 
are devices that consist of antigens 
and antisera used in serological tests 
to identify antibodies to influenza in 
serum. The identification aids in the 
diagnosis of influenza (flu) and 
provides epidemiological 
information on influenza. Influenza 
is an acute respiratory tract disease, 
which is often epidemic. 
 1. Modification of the 
classification name 
and description. 
2. Reference to CDC 
“influenza virus” 
mandarin (Chinese) 
terminology. 
Amendment the 
description to 
distinguish with the 
classification 
Influenza virus 
antigen detection test 
system (C.3328). 
 
D.5905 Noncontinuous 
ventilator 
(IPPB) and 
accessories 2 A noncontinuous ventilator 
(intermittent positive pressure 
breathing-IPPB) and accessories are 
the device intended to deliver 
intermittently an aerosol to a 
patient's lungs or to assist a patient's 
breathing. This device is intended to 
use with accessories such as masks 
of noncontinuous ventilator. D.5905 Noncontinuous 
ventilator 
(IPPB) 2 A noncontinuous ventilator 
(intermittent positive pressure 
breathing-IPPB) is the device 
intended to deliver intermittently an 
aerosol to a patient's lungs or to 
assist a patient's breathing. 1. Modification of the 
classification name 
and description. 
2. This amendment 
includes accessories 
such as masks of 
discontinuous 
breathing apparatus 
(ventilators) in this 
classification. In order 
to avoid confusion 
between this 
classification 
Nonrebreathing mask 
(D. 5570) and Oxygen Page 6 of 10  
 Amended regulation Current regulation 
Description Classification   
number Classification 
name Class Description Classification   
number Classification 
name Class Description 
mask (D.5580), the 
classification name 
and identification are 
revised accordingly. 
G.5220 Ear, nose, and 
throat drug 
administration 
device and 
contained 
substance 1,2 (a)Description. An ear, nose, and 
throat drug administration device is 
one of a group of ear, nose, and 
throat devices intended specifically 
to administer medicinal substances 
to treat ear, nose, and throat 
disorders. These instruments 
include the powder blower, dropper, 
ear wick, manual nebulizer pump, 
and nasal inhaler.(b)Classification:  
Class 1: The device does not 
contain substan ce (liquid or other 
substance), If the device contains 
flushing solution or other substa nce 
(solution, solute, powder and etc.)  
for its intended purpose , and the 
solution or substance used in 
combination with the device is not 
regulated as a medicinal substance.  G.5220 Ear, nose, and 
throat drug 
administration 
device. 1,2 (a)Description. An ear, nose, and 
throat drug administration device is 
one of a group of ear, nose, and 
throat devices intended specifically 
to administer medicinal substances 
to treat ear, nose, and throat 
disorders. These instruments 
include the power blower, dropper, 
ear wick, manual nebulizer pump , 
and nasal inhaler. (b) Classification: 
(1) Class 1: The device does not 
contain liquid. (2) Class 2: The 
device contains flushing liquid 
which is not regulated as a 
medicinal substance. 
 1.  Modification of the 
classification name 
and description. 
2. Modification of the 
classification 
description to include 
other substance 
containing in the 
device. Correction of 
the typo (power to 
powder). Page 7 of 10  
 Amended regulation Current regulation 
Description Classification   
number Classification 
name Class Description Classification   
number Classification 
name Class Description 
H.5320 Nonimplanted 
electrical 
continence 
device. 2 A nonimplanted electrical 
continence device is a device that 
consists of a pair of electrodes on a 
plug or a pessary that are connected 
by an electrical cable to a powered  
pulse source. The plug or pessary is 
inserted into the rectum or into the 
vagina and used to stimulate the 
muscles of the pelvic floor to 
maintain urinary or fecal 
continence. When necessary, the 
plug or pessary may be removed by 
the user. This classification  
excludes an AC- powered 
nonimplanted electrical continence 
device and the powered vaginal 
muscle stimulator for therapeutic 
use (L.5940). H.5320 Nonimplanted 
electrical 
continence 
device. 2 A nonimplanted electrical 
continence device is a device that 
consists of a pair of electrodes on a 
plug or a pessary that are connected 
by an elect rical cable to a 
battery-powered pulse source. The 
plug or pessary is inserted into the 
rectum or into the vagina and used 
to stimulate the muscles of the 
pelvic floor to maintain urinary or 
fecal continence. When necessary, 
the plug or pessary may be removed 
by the user. This classification  
excludes an AC- powered 
nonimplanted electrical continence 
device and the powered vaginal 
muscle stimulator for therapeutic 
use (L.5940). 1. Modification of the 
classification 
description. 
2. The original 
identification 
describes only 
battery-powered 
nonimplanted 
electrical continence 
devices. This amended 
description extended 
to include 
AC-powered 
nonimplanted 
electrical continence 
devices. 
I.4460 Surgeon's 
glove. 1,2 A surgeon's glove is a device made 
of natural or synthetic rubber 
intended to be worn by operating 
room personnel to protect a surgical 
wound from contamination. The 
lubricating or dusting powder used 
in the glove is excluded. A 
surgeon's glove containing 
biodegradable powders which 
complies with U.S.P. (for example 
corn powders) is cl ass 2 
device.Non- clinical performance 
data of the barrier property (water I.4460  Surgeon's 
glove. 1,2 A surgeon's glove is a device made 
of natural or synthetic rubber 
intended to be worn by operating 
room personnel to protect a surgical 
wound from contamination. The 
lubricating or dusting powder used 
in the glove is excluded. A surgeon's 
glove containing biodegradable 
powders which complies with 
U.S.P. (for example corn powders) 
is class 2 device. 1. Modification of the 
classification 
description. 
2. In order to improve 
product safety, 
effectiveness and 
quality, glove products 
should comply with 
standards. Regarding 
to the international 
trend of banning 
powdered gloves, this 
classification provides Page 8 of 10  
 Amended regulation Current regulation 
Description Classification   
number Classification 
name Class Description Classification   
number Classification 
name Class Description 
leak) and tensile strength should 
comply with ISO 11193-1, ASTM 
D3578, ASTM D5250, ASTM 
D6319, EN 455 or equivalent 
standards.A non- powdered (powder 
free) surgeon's glove should comp ly 
with EN ISO 21171, ASTM 6124 or 
equivalent standards. The amount of 
residual powders on a glove should 
not exceed 2.0 mg. 
 guidance on 
examining 
non-powdered 
(powder free) gloves.  
J.6250 Patient 
examination 
glove. 1 A patient examination glove is a 
disposable device intended for 
medical purposes that is worn on 
the examiner's hand or finger to 
prevent contamination between 
patient and examiner.Materials of 
patient examination gloves should 
comply with the barrier prop erty 
(water leak) and tensile strength 
requirements of ISO 11193-1,  
ASTM D3578, ASTM D5250,  
ASTM D6319, EN 455 or 
equivalent standards.A 
non-powdered (powder free) patient 
examination glove should comply 
with residual powders requirements 
of EN ISO 21171, ASTM 6124 or 
equivalent standards. The amount of J.6250 Patient 
examination 
glove. 1 A patient examination glove is a 
disposable device intended for 
medical purposes that is worn on 
the examiner's hand or finger to 
prevent contamination between 
patient and examiner. 
 1. Modification of the 
classification 
description. 
2. In order to improve 
product safety, 
effectiveness and 
quality, glove products 
should comply with 
standards. Regarding 
to the international 
trend of banning 
powdered gloves, this 
classification provides 
guidance on 
examining 
non-powdered 
(powder free) gloves.  
 Page 9 of 10  
 Amended regulation Current regulation 
Description Classification   
number Classification 
name Class Description Classification   
number Classification 
name Class Description 
residual powders on a glove should 
not exceed 2.0 mg. 
 
O.3800 Motorized 
vehicle for 
medical 
purposes 2 A motorized vehicle for medical 
purposes is a gasoline- fueled or 
battery-powered device intended for 
medical purposes that is used for 
transportation by mobility disabled 
persons. The maximum speed limit 
of motorized vehicles for medical 
purposes is 10 km/h. 
 O.3800 Motorized 
vehicle for 
medical 
purposes 2 A motorized vehicle is a 
gasoline-fueled or battery-powe red 
device intended for medical  
purposes that is used for outside 
transportation by disabled persons.  
The maximum speed limit of 
motorized vehicles for medical 
purposes is 10 km/h. 1. Modification of the 
classification 
description. 
2. The classification 
description is 
amended to clarify 
that a motorized 
vehicle for medical 
purposes is used for 
transportation by 
mobility disabled 
persons. 
O.3850 Mechanical 
wheelchair. 1 A mechanical wheelchair is a 
manually operated device with 
wheels that is intended for medical 
purposes to provide mobility to 
persons restricted to a sitting 
position.Mechanical wheelchairs  
shall comply with the performance 
requirements of national standard 
CNS 14964-8, ISO 7176-8 or 
equivalent international standards. O.3850 Mechanical 
wheelchair.  1 A mechanical wheelchair is a 
manually operated device with 
wheels that is intended for medical 
purposes to provide mobility to 
persons restricted to a sitting 
position. 
 1. Modification of the 
classification 
description. 
2. In order to improve 
the product quality,  
mechanical 
wheelchairs shall 
comply with  product 
standards similar to 
requirements of other Page 10 of 10  
 Amended regulation Current regulation 
Description Classification   
number Classification 
name Class Description Classification   
number Classification 
name Class Description 
countries. 
O.3860 Powered 
wheelchair. 2 A powered wheelchair is a 
battery-operated device with wheels 
that is intended for medical 
purposes to provide mobility to 
persons restricted to a sitting 
position.The maximum speed limit  
of powered wheelchairs is 10 km/h. 
This classification contains external 
power components for use in 
mechanical wheelchairs O.3860 Powered 
wheelchair. 2 A powered wheelchair is a 
battery-operated device with wheels 
that is intended for medical 
purposes to provide mobility to 
persons restricted to a sitting 
position. 
 1.  Modification of the 
classification 
description. 
2. Regarding to the 
product safety, this 
classification defines 
maximum speed limit 
of powered 
wheelchairs. Since the 
risk of external power 
components for use in 
mechanical 
wheelchairs is similar 
to similar motorized 
vehicles for medical 
purposes (O.3800), 
this classification 
includes external 
power components for 
use in mechanical 
wheelchairs.