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Appendix-A
File No. 29/Misc./03/2020-DC (181)
Drugs Controller General (India)
Directorate General of Health Services
Central Drugs Standard Control Organisation
FDA Bhawan, Kotla Road, New Delhi
Notice
Classification of Medical Devices Pertaining to Obstetrical and
Gynecological
Sr.
DEVICE NAME INTENDED USE Risk
No.
Class
Abdominal
Non- invasive medical device placed at abdomen to alleviate
1 decompression C
abdominal pain during pregnancy or delivery.
chamber
Abdominal
A dedicated pump used with hood-like device to control and
2 decompression C
reduce abdominal pressure of a pregnant women.
chamber pump
A non-sterile, manual, syringe-like device to aspirate fluid from
Abortion suction
the uterus for treatment of incomplete abortion, first
3 system manual B
trimester abortion, and/or for menstrual regulation. Also used
aspirator
for endometrial biopsy.
Birthing bed/table,
4 Bed used during labor and delivery. A
powered
A device that records fetal heart rate and uterine
5 Cardiotocograph C
contraction simultaneously.
A device that converts birthing contractions to electrical signals
Cardiotocograph
6 and is used together with cardiotocograph (CTG) which C
transducer
displays the signals.
An assembly of devices intended to be used to continuously
Cardiotocography
measure and wirelessly transmit foetal heart rate and uterine
7 telemetric C
contraction signals from a patient to a
monitoring system
monitor.
Cardiotocography A part of wireless telemeter system. It receives signals from
8 telemetric transmitter that senses fetal heart rate and uterine C
monitoring system contraction during labor.
receiver
Cardiotocography
It transmits signals related to fetal heart rate and uterine
9 telemetric C
contractions to the receiver.
monitoring system
transmitter
For providing intercervical nerve block during
gynaecological diagnostic tests such as dilation and
Cervical
10 curettage, small excisional procedures such as B
anaesthesia kit
endometrial biopsy, or for pain management during
labour and/or delivery. This is a single-use device.
Cervical A sharp bevel-edged, hollow tubular metal instrument
11 anaesthesia needle, intended to be used to administer anaesthetic agent to B
reusable or single function as an intracervical nerve-block.
use
Special microscope for examination of female genital
12 Colposcope B
organs (e.g., vagina, cervix).
Page 1 of 9Contraceptive cervical
Device inserted into the cervix to prevent semen from
13 cap, reusable or C
entering the uterus.
single use
A chemical substance (e.g., nonoxynol-9) intended to be
Contraceptive introduced with an applicator or the finger into the vagina
14 C
spermicide before sexual intercourse, to destroy sperm
(spermatozoa) to prevent pregnancy.
Bubble like device works as a physical barrier to prevent
15 Contraceptive sponge C
spermatic invasion into uterus.
A circular device placed in the vagina prior to intercourse
16 Diaphragm pessary C
to mechanically prevent conception.
A collection of devices designed to remove superficial tissue
17 Endocervical aspirator from the mucous membrane lining the cervical canal B
(endometrium) through manually-powered suction.
Sterile devices intended to be used for the collection,
Endocervical specimen
preservation, and transport of cellular and/or other material
18 collection kit, no B
collected from the endocervix for culture, analysis, and/or
additive
other investigation
(a) Endometrial biopsy
curette, reusable Surgical instrument used for the removal of small amounts of B
(b) Endometrial biopsy endometrial secretions and/or tissue from the uterus for biopsy
19 curette, single purposes.
B
use/disposable
For the collection of a tissue sample taken from the lining of the
20 Endometrial biopsy kit B
uterus (endometrium).
Endometrial cytology A brush used to collect mucosal cell for pathological
21 B
brush diagnosis during endoscopic examination.
Fallopian tube biopsy A sterile device intended to be inserted through a
22 everting-balloon hysteroscope to obtain biopsy samples from a fallopian tube B
catheter for cytological examination.
A collection of sterile devices for the trans uterine
Fallopian tube
23 catheterization of the fallopian tubes to inject dye or B
catheterization kit
contrast medium for the evaluation of tubal patency.
Active invasive device designed to insufflate the
Fallopian tube
24 Fallopian tubes with a gas [typically carbon dioxide B
insufflator
(CO2)] to maintain tubal patency for a procedure.
Contraceptive implantable device implanted into the uterine
Fallopian tube
end of the fallopian tubes to function as a contraceptive by
25 occlusion insert D
obstructing the natural fallopian tube passage.
(a) Fixed-diameter
cervical dilator, B
reusable
To dilate the cervical canal with balloon when uterine does
26 (b) Fixed-diameter
not dilate enough due to inertia uteri.
cervical dilator,
B
single
use/disposable
Page 2 of 9Flexible fibreoptic Flexible endoscope for visual examination, diagnosis, and
27 B
culdoscope treatment of urinary bladder and urethra.
Flexible fibreoptic For the visual examination and treatment of the canal of the
28 B
hysteroscope cervix and the uterine cavity (uterus).
Flexible fibreoptic For the visual examination and treatment of the
29 B
laparoscope abdominal/retroperitoneal cavity and its organs
Flexible fibreoptic For the visual examination and treatment of the
30 B
mammary ductoscope mammary duct.
Flexible fibreoptic For the visual examination and treatment of the fallopian tubes
31 B
salpingoscope (oviducts).
For the visual examination, treatment, and ultrasonic
Flexible ultrasound
32 imaging of the abdominal/retroperitoneal cavity and its B
laparoscope
organs.
Flexible video For the visual examination and treatment of the female
33 B
culdoscope peritoneal cavity and organs.
Flexible video For the visual examination and treatment of the canal of the
34 B
hysteroscope cervix and the uterine cavity (uterus).
Flexible video For the visual examination and treatment of the
35 B
laparoscope abdominal/retroperitoneal cavity and its organs.
Flexible video For the visual examination and treatment of the
36 B
mammary ductoscope mammary duct.
Flexible video For the visual examination and treatment of the fallopian tubes
37 B
salpingoscope (oviducts).
Uses sound stimuli to assess foetal well-being. This device
is used to evaluate the status of the foetus as expressed
Foetal acoustic
38 by, e.g., foetal heart rate changes or foetal acid-base B
stimulator
status, in antepartum tests and/or during intrapartum
monitoring.
A sterile non-bioabsorbable tubular device implanted in the
bladder of a foetus with post-vesicular obstructive uropathy,
39 Foetal bladder shunt to decompress the urinary tract for urine to pass from bladder C
into the amniotic sac, until the defect
can be surgically repaired after birth
Invasive device to collect fetal blood through uterine
40 Foetal blood sampler B
cervix.
Active device designed to detect, measure, and display foetal
41 Foetal cardiac monitor C
heart activity during the perinatal period
Foetal pleuro-amniotic Sterile implantable device used to continuously drain
42 C
catheter fetal pleural effusion to maternal amniotic cavity.
Foetal scalp Placed directly on the scalp of the fetus in the uterus to
43 C
electrode, clip monitor fetal vital signs.
Mechanical hearing device used to listen to fetal
44 Foetal stethoscope A
heartbeat.
Foetal vacuum
A device used to extract the head of the fetus with a
45 extraction cup, B
vacuum cup.
reusable or single use
Page 3 of 9A battery-powered vacuum measuring device that is
connected via tubing to the suction line of a foetal vacuum
Foetal vacuum
extracting cup, to measure and record data related to a
46 extraction system B
vacuum-assisted delivery such as level of vacuum applied,
monitor
the number and duration of pulls, and
number of pop-offs.
Foetal vacuum
extraction system, To facilitate the delivery of a foetus during vaginal childbirth
47 B
manual, reusable or or Caesarean.
single use
Foetal vacuum
To facilitate the delivery of a foetus during vaginal childbirth
48 extraction system, B
or Caesarean.
pneumatic
To imitate a variety of physiological parameters and conditions
Foetal/maternal
(both foetal and maternal) expressed during pregnancy in order
multiple physiological
49 to test and calibrate foetal and patient monitoring and recording B
parameter simulation
equipment, check patient cable
kit
continuity, or train healthcare providers.
To imitate a variety of physiological parameters and conditions
Foetal/maternal (both foetal and maternal) expressed during pregnancy in order
50 multiple physiological to test and calibrate foetal and patient monitoring and recording B
parameter simulator equipment, check patient cable
continuity, or train healthcare providers.
51 Gynaecological bib A piece of cloth worn by the patient. A
Gynaecological
To support a woman's body in the appropriate positions during
52 examination/treatment A
gynaecological examinations.
table
A component of a modular operating table designed as a
Gynaecological
53 detachable table top constructed for gynaecological A
operating table top
surgical procedures.
Gynaecological
operating table,
Active device designed to support a patient during
54 electrohydraulic or A
gynaecological surgical procedures
electromechanical or
hydraulic
(a) Gynaecological
B
scissors, reusable
To cut tissues during a gynaecological surgical
55 (b) Gynaecological
procedure; it is not intended for obstetric use.
scissors, single B
use/disposable
To improve visualization of anatomical structures via
Gynaecological
56 transmitted light during gynaecological surgery (e.g., on the A
surgical microscope
fallopian tubes).
A device used during a medical/surgical procedure to steadily
57 Heel stirrup hold a patient's foot (feet) by cradling the heel or A
the whole foot.
Hysteroscopic A device that sends the gas into the fallopian tube to
58 B
insufflator maintain the patency of the tubes.
Used during endoscopic procedures of the uterus to distend
(expand by pressure) the uterus by filling the uterine cavity
Hysteroscopic
with a liquid to improve visualization and enlarge the surgical
59 irrigation/insufflation B
field. It also circulates the fluid to provide irrigation that will
system
remove tissue/debris from the site.
Page 4 of 9(a) Intrauterine
To aspirate fluid/material from the uterus for treatment of B
cannula, reusable
incomplete abortion, first trimester abortion, and/or for
60 (b) Intrauterine
menstrual regulation; it may also be intended for endometrial
cannula, single B
biopsy.
use/disposable
A sterile, flexible tube with an inflatable balloon inserted into
Intrauterine
the uterus and distended with a medium (e.g., sterile
61 haemostatic balloon B
water, medical air or other appropriate gas) to reduce
catheter
postpartum bleeding with pressure.
Intrauterine Inserted into the uterus to reduce postpartum bleeding
62 haemostatic suction through aspiration of blood/debris and induction of uterine B
catheter contractions.
Intrauterine imaging Intrauterine injection of an opaque tracer medium, to
63 B
medium catheter facilitate radiography of the fallopian tubes/uterus.
Intrauterine imaging Sterile devices intended for the intrauterine injection of an
64 medium opaque tracer medium, to facilitate radiography of the B
catheterization kit fallopian tubes/uterus.
(a) Laparoscope laser
B
coupler To connect the laparoscope to the laser or the laser arm for
65
laparoscopic laser treatment.
(b) Laparoscope laser
A
adaptor
For the visual examination and treatment of the
66 Laparoscope system abdominal/retroperitoneal cavity and its organs B
(laparoscopy).
For the visual examination and treatment of the
Laparoscope system,
67 abdominal/retroperitoneal cavity and its organs B
reusable or single use
(laparoscopy).
Manual expandable To dilate the cervical canal with balloon when uterine
68 B
cervical dilator does not dilate enough due to inertia uteri.
To imitate a foetal heart (e.g., foetal heart ultrasound signals)
when used in combination with a foetal/maternal multiple
69 Mechanical foetal physiological parameter simulator in order to test foetal
B
heart simulator monitoring and recording equipment [e.g., cardiotocograph
(CTG)], check patient cable continuity,
or to train healthcare providers.
Active surgical instrument designed for grasping, mobilizing,
Motorized
70 and suturing tissues/vessels under direct or B
laparoscopic forceps
endoscopic visualization during a surgical procedure.
Papanicolaou smear
Used to collect and prepare pap smears samples in a
71 kit or Endometrial B
medical institute.
sampling kit
72 Pelvic examination kit For performing pelvic examination B
A measuring device used to determine the pelvic
73 Pelvimeter B
dimensions.
An endoscope used for visual examination and diagnosis of
74 Pelviscope B
pelvis.
75 Perineal warmer it is useful for pain relief in the vulva after episiotomy. B
To determine perineal muscle strength through
resistance to spontaneous contraction of perineal
76 Perineometer B
muscle. Also used to diagnose and treat urinary incontinence
and sexual dysfunction through movement.
Page 5 of 9Pudendal A collection of sterile devices designed to deliver
77 B
anaesthesia kit anaesthetic agent to the external genitalia of humans.
An endoscope used for visual examination, diagnosis
78 Resectoscope B
and treatment, especially for resection of tissues.
An endoscope with a rigid inserted portion intended for the
79 Rigid culdoscope visual examination and treatment of the female peritoneal B
cavity and organs.
An endoscope with a rigid inserted portion intended for the
Rigid fibreoptic
80 visual examination and treatment of the canal of the cervix B
hysteroscope
and the uterine cavity (uterus).
An endoscope with a rigid inserted portion intended for the
Rigid mammary
81 visual examination and treatment of the mammary duct B
ductoscope
An endoscope with a rigid inserted portion intended for the
Rigid optical
82 visual examination and treatment of the B
laparoscope
abdominal/retroperitoneal cavity and its organs.
An endoscope with a rigid inserted portion intended for the
83 Rigid salpingoscope visual examination and treatment of the fallopian tubes B
(oviducts)
An endoscope with a rigid inserted portion, combined with
Rigid ultrasound an ultrasound probe, intended for the visual examination,
84 B
laparoscope treatment, and ultrasonic imaging of the
abdominal/retroperitoneal cavity and its organs
Active device intended to allow visual examination and
Rigid video
85 treatment of the canal of the cervix and the uterine cavity B
hysteroscope
(uterus).
An endoscope with a rigid inserted portion intended for the
Rigid video
86 visual examination and treatment of the B
laparoscope
abdominal/retroperitoneal cavity and its organs
(a) Suprapubic
needle, surgical, B
reusable
Percutaneously puncture the lower abdominal wall to
87 (b) Suprapubic
provide suprapubic access for surgical repair.
needle, surgical,
B
single use/
disposable
88 Umbilical ligator Surgical device used for umbilical cord ligation. A
Used to inject liquid, drug, or other substance into uterus. It is a
89 Uterine injector B
reusable device.
Uterine manipulator Allow manipulation of the uterus under suction whilst
90 cervical preventing laparoscopic insufflation gas from escaping from B
cup/transilluminator the cervix (during hysterectomy).
(a) Uterine
manipulator, B
Surgical instrument designed to mechanically manipulate the
reusable
91 position of the uterus during a gynaecological intervention
(b) Uterine
manipulator, single B
use/disposable
Page 6 of 9A hand-held, surgical instrument used to introduce
92 Uterine packer dressings into the uterus or vagina. This is a reusable A
device.
(a) Uterine probe,
B
reusable
For exploring the uterus during a surgical procedure. Used
93 (b) Uterine probe,
as a component of a uterine manipulator
single B
use/disposable
Uterus-supporting
94 Inserted into the vagina to hold the uterus in place. B
pessary
Vaginal applicator,
95 A device designed to apply medication to the vagina. A
reusable or single use
(a) Vaginal dilator,
B
reusable Inserted into the vagina to dilate a narrow vaginal opening
96 (b) Vaginal dilator, due to congenital defect. Can be used during examination,
single use/ treatment or surgical procedure. B
disposable
Vaginal douche, To deliver a liquid (usually solution) directly into the
97 B
reusable or single use vaginal cavity for hygienic purpose as a douche.
A device that measures the length and diameter of
98 Vaginometer A
vagina.
For paediatric vaginal examination. To search foreign
99 Vaginoscope B
matter or bleeding site.
Used to hold an organ at proper position (i.e., viscera) while
Viscera retention
the surgeon performs a suturing procedure
100 paddle or Visceral B
(typically internal wound closure). It is also implanted into a
retainer
surgical site temporarily.
Active device transmitted through the female breast to visualize
Breast
101 translucent tissue for the diagnosis of cancer, or C
transilluminator
other conditions, diseases or abnormalities.
A surgical instrument used to rupture the amniotic
Amniotic membrane
102 membrane to assist in childbirth, without causing injury to the A
perforator, reusable
mother or foetus
A surgical instrument used to rupture the amniotic
103 Amniotome, reusable membrane to assist in childbirth, without causing injury to the B
mother or foetus
inserted into the vagina to facilitate management of female
Bladder-supporting
104 urinary incontinence and/or to reduce bladder B
pessary
prolapse.
Catheter-tip A device intended to be incorporated into the distal end
105 B
transducer, pressure of a catheter (not included) to measure pressure.
Foetal Doppler Active non-invasive device to detect foetal heart beats
106 C
system using ultrasound/Doppler technology.
Placed on the surface of a pregnant woman's abdomen
Foetal Doppler
107 to detect foetal heart beats using ultrasonic/Doppler C
system probe
technology.
It is intended for cryopreservation of human semen for later use
Preservation
108 in Assisted Reproductive procedure. It may include medicinal
medium for
and biological components like glycerol, gentamicin, Test Yolk C
human semen
Buffer (TYB),etc.
It is intended for use in Assisted Reproductive procedure
Sperm
109 involving the cryopreservation and storage of semen. C
cryopreservation
medium
Page 7 of 9It is intended for use in Assisted Reproductive procedure for
Vitrification freezing kit
110 vitrification and storage of human oocytes (MII), Pronuclear (PN)
zygotes through day 3 cleavage stage embryos and blastocyst C
stage embryos. It may include medicinal and protein
supplements like Gentamicin, Dextran Serum Supplement
(DSS), etc.
Intended for use in the thawing of vitrified oocytes (MII),
Vitrification
111 pronuclear (PN) zygotes through day 3 cleavage stage embryos
Thawing/Warming kit
and blastocyst stage embryos that have been vitrified using C
vitrification freeze kit.It may include medicinal and protein
supplements like Gentamicin, Dextran Serum Supplement
(DSS), etc.
Intended for use in Assited reproductive procedure which
Handling medium
involves manipulation of gametes or embryos. Specially, it is
112 indicated for use as an oocyte retrival medium during ovarian
follicle aspiration procedure, washing sperm prior to IVF and C
ICSI (Intra Cytoplasmic sperm injection) fertilization procedures,
and for transport of the embryo to the utreus during embryo
transfer procedure. It may include medicinal and protein
supplements like Gentamicin, Human Serum Albumin (HSA),
etc.
Used in Assisted reproductive procedure which includes
Gamete and embryo
113 retrieval, culture, transport,storage, handling, and transfer of C
retrieval, storage and
human gametes and embryos by creating a physiological
transfer medium
environment. It may include buffer solution and medicinal
substance like Gentamicin, etc.
Intended for use in removing cumulus cells surrounding oocytes
Hyaluronidase solution
(denudation) in preparation for ICSI (Intra cytoplasmic sperm
114 injection) or other Assisted reproductive procedures. It is a C
enzymatic solution containing of bovine derived hyaluronidase in
a HEPES (4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid)
buffered HTF (Human Tubal Fluid) medium supplemented with
therapeutic grade human serum albumin and gentamicin sulfate.
Used in Assisted reproductive procedure which include human
Polyvinylpyrrolidone
gamete and embryo manipulation. It uses PVP solution for C
(PVP) Solution
115 immobilizing sperm for ICSI (Intra cytoplasmic sperm injection)
procedures.This solution may include protein supplement like
Human Serum Albumin (HSA), etc.
It is intended for separation of the motile fraction of sperm from
Sperm Separation
116 seminal fluid. It works on the principle of isopycnic separation. B
Medium
Designed to maintain sperm quality on the table top without CO2
Sperm processing
117 incubation. This procedure includes use of this medium for C
media
sperm washing by supporting all steps of sperm preparation
prior to fertilization. It may contains protien supplements like
human serum albumin (HSA), bovine serum albumin, etc.
Intended for use in ART Laboratories procedure requiring a non-
Water for Assisted
118 pyrogenic high quality pure grade of water. B
Reproductive
Technologies
It is intended for use in assisted reproductive procedures which
In Vitro embryo Culture
119 include gamete and embryo manipulation. It is used as a culture C
medium, through day
medium for human gametes and embryos from fertilization
5/6 of development
through day 5/6 of development. It may include medicinal
substance like Gentamicin and protein supplement like Human
serum Albumin (HSA), etc.
Page 8 of 9This medium is intended for use in assisted reproductive
In Vitro embryo culture
procedures which include human gamete and embryo C
medium, through day 3
120 manipulation. It is used as a culture medium through day 3 of
of development
development. It may be used as a stand-alone medium, or as
the first stage of a sequential medium protocol. It may include
medicinal substance like Gentamicin, etc.
For use in assisted reproductive procedures which include
Protein supplement for
121 gamete and embryo manipulation, as a supplement for culture B
in vitro embryo culture
media. It may include protein supplement like Human Serum
Albumin (HSA), Synthetic Serum Substitute (SSS), Dextran
Serum Supplement (DSS), etc. Not for use as an injectable
product.
It is used as an overlay to cover small volumes of culture media
Oil for embryo culture
122 during human embryo and gamete manipulation to prevent B
evaporation of culture media.
Placed in the vagina to collect blood and cellular debris
Menstrual Cup
123 discharges during menstruation and discharges outside of the B
monthly menses.
Page 9 of 9