S.No.

Name of the Medical Device as per Medical Device Rules 2017

INTENDED USE

Risk Class

1

Abdominal decompression chamber

Non- invasive medical device placed at abdomen to alleviate abdominal pain during pregnancy or delivery.

C

2

Abdominal decompression chamber pump

A dedicated pump used with a hood-like device to control and reduce abdominal pressure of a pregnant woman.

C

3

Abortion suction system manual aspirator

A non-sterile, manual, syringe-like device to aspirate fluid from the uterus for treatment of incomplete abortion, first trimester abortion, and/or for menstrual regulation. Also used for endometrial biopsy.

B

4

Cardiotocograph

A device that records fetal heart rate and uterine contraction simultaneously.

C

5

Cardiotocograph transducer

A device that converts birthing contractions to electrical signals and is used together with cardiotocography (CTG) which displays the signals.

C

6

Cardiotocography telemetric monitoring system

An assembly of devices intended to be used to continuously measure and wirelessly transmit fetal heart rate and uterine contraction signals from a patient to a monitor.

C

7

Cardiotocography telemetric monitoring system receiver

A part of a wireless telemetry system. It receives signals from a transmitter that senses fetal heart rate and uterine contraction during labor.

C

8

Cardiotocography telemetric monitoring system transmitter

It transmits signals related to fetal heart rate and uterine contractions to the receiver.

C

9

Cervical anaesthesia kit

For providing inter cervical nerve block during gynaecological diagnostic tests such as dilation and curettage, small excisional procedures such as endometrial biopsy, or for pain management during labour and/or delivery. This is a single-use device.

B

10

Cervical anaesthesia needle, reusable or single use

A sharp bevel-edged, hollow tubular metal instrument intended to be used to administer anaesthetic agent to function as an intracervical nerve-block.

B

11

Colposcope

Special microscope for examination of female genital organs (e.g., vagina, cervix).

B

12

Contraceptive cervical cap, reusable or single use

Device inserted into the cervix to prevent semen from entering the uterus.

C

13

Contraceptive spermicide

A chemical substance (e.g., nonoxynol-9) intended to be introduced with an applicator or the finger into the vagina before sexual intercourse, to destroy sperm (spermatozoa) to prevent pregnancy.

C

14

Contraceptive sponge

Bubble-like devices work as a physical barrier to prevent spermatic invasion into the uterus.

C

15

Diaphragm pessary

A circular device placed in the vagina prior to intercourse to mechanically prevent conception.

C

16

Endocervical specimen collection kit, no additive

Sterile devices intended to be used for the collection, preservation, and transport of cellular and/or other material collected from the endocervix for culture, analysis, and/or other investigation

B

17

(a) Endometrial biopsy curette, reusable

Surgical instrument used for the removal of small amounts of endometrial secretions and/or tissue from the uterus for biopsy purposes.

B

(b) Endometrial biopsy curette, single use/disposable

B

18

Endometrial biopsy kit

For the collection of a tissue sample taken from the lining of the uterus (endometrium).

B

19

Endometrial cytology brush

A brush used to collect mucosal cells for pathological diagnosis during endoscopic examination.

B

20

Fallopian tube biopsy everting-balloon catheter

A sterile device intended to be inserted through a hysteroscope to obtain biopsy samples from a fallopian tube for cytological examination.

B

21

Fallopian tube catheterization kit

A collection of sterile devices for the trans uterine catheterization of the fallopian tubes to inject dye or contrast medium for the evaluation of tubal patency.

B

22

Fallopian tube insufflator

Active invasive device designed to insufflate the Fallopian tubes with a gas [typically carbon dioxide (CO2)] to maintain tubal patency for a procedure.

B

23

Fallopian tube occlusion insert

Contraceptive implantable device implanted into the uterine end of the fallopian tubes to function as a contraceptive by obstructing the natural fallopian tube passage.

D

24

(a) Fixed-diameter cervical dilator, reusable

To dilate the cervical canal with a balloon when the uterine does not dilate enough due to inertia

B

(b) Fixed-diameter cervical dilator, single use/disposable

To dilate the cervical canal with a balloon when the uterine does not dilate enough due to inertia.

B

25

Flexible fibreoptic culdoscope

Flexible endoscope for visual examination, diagnosis, and treatment of urinary bladder and urethra.

B

26

Flexible fibreoptic hysteroscope

For the visual examination and treatment of the canal of the cervix and the uterine cavity (uterus).

B

27

Flexible fibreoptic laparoscope

For the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs

B

28

Flexible fibreoptic mammary ductoscope

For the visual examination and treatment of the mammary duct.

B

29

Flexible fibreoptic salpingoscope

For the visual examination and treatment of the fallopian tubes (oviducts).

B

30

Flexible video culdoscope

For the visual examination and treatment of the female peritoneal cavity and organs.

B

31

Flexible video hysteroscope

For the visual examination and treatment of the canal of the cervix and the uterine cavity (uterus).

B

32

Flexible video laparoscope

For the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs.

B

33

Flexible video mammary ductoscope

For the visual examination and treatment of the mammary duct.

B

34

Flexible video salpingoscope

For the visual examination and treatment of the fallopian tubes (oviducts).

B

35

Foetal acoustic stimulator

Uses sound stimuli to assess fetal well-being. This device is used to evaluate the status of the fetus as expressed by, e.g., foetal heart rate changes or foetal acid-base status, in antepartum tests and/or during intrapartum monitoring.

B

36

Foetal bladder shunt

A sterile non-bioabsorbable tubular device implanted in the bladder of a foetus with post-vesicular obstructive uropathy, to decompress the urinary tract for urine to pass from bladder into the amniotic sac, until the defect can be surgically repaired after birth

C

37

Foetal blood sampler

Invasive device to collect fetal blood through uterine cervix.

B

38

Foetal pleuro-amniotic catheter

Sterile implantable device used to continuously drain fetal pleural effusion to maternal amniotic cavity.

C

39

Foetal scalp electrode, clip

Placed directly on the scalp of the fetus in the uterus to monitor fetal vital signs.

C

40

Foetal stethoscope

Mechanical hearing device used to listen to fetal heartbeat.

A

41

Foetal vacuum extraction cup, reusable or single use

A device used to extract the head of the fetus with a vacuum cup.

B

42

Foetal vacuum extraction system monitor

A battery-powered vacuum measuring device that is connected via tubing to the suction line of a foetal vacuum extracting cup, to measure and record data related to a vacuum-assisted delivery such as level of vacuum applied, the number and duration of pulls, and number of pop-offs.

B

43

Foetal vacuum extraction system, manual, reusable or single use

To facilitate the delivery of a fetus during vaginal childbirth or Caesarean.

B

44

Foetal vacuum extraction system, pneumatic

To facilitate the delivery of a fetus during vaginal childbirth or Caesarean.

B

45

Foetal/maternal multiple physiological parameter simulation kit

To imitate a variety of physiological parameters and conditions (both foetal and maternal) expressed during pregnancy in order to test and calibrate foetal and patient monitoring and recording equipment, check patient cable continuity, or train healthcare providers.

B

46

Foetal/maternal multiple physiological parameter simulator

To imitate a variety of physiological parameters and conditions (both foetal and maternal) expressed during pregnancy in order to test and calibrate foetal and patient monitoring and recording equipment, check patient cable continuity, or train healthcare providers.

B

47

(a) Gynaecological scissors, reusable

To cut tissues during a gynaecological surgical procedure; it is not intended for obstetric use.

B

(b) Gynaecological scissors, single use/disposable

B

48

Hysteroscopic insufflator

A device that sends the gas into the fallopian tube to maintain the patency of the tubes.

B

49

Hysteroscopic irrigation/insufflation system

Used during endoscopic procedures of the uterus to distend (expand by pressure) the uterus by filling the uterine cavity with a liquid to improve visualization and enlarge the surgical field. It also circulates the fluid to provide irrigation that will remove tissue/debris from the site.

B

50

(a) Intrauterine cannula, reusable

To aspirate fluid/material from the uterus for treatment of incomplete abortion, first trimester abortion, and/or for menstrual regulation; it may also be intended for endometrial biopsy.

B

(b) Intrauterine cannula, single use/disposable

B

51

Intrauterine haemostatic balloon catheter

A sterile, flexible tube with an inflatable balloon inserted into the uterus and distended with a medium (e.g., sterile water, medical air or other appropriate gas) to reduce postpartum bleeding with pressure.

B

52

Intrauterine haemostatic suction catheter

Inserted into the uterus to reduce postpartum bleeding through aspiration of blood/debris and induction of uterine contractions.

B

53

Intrauterine imaging medium catheter

Intrauterine injection of an opaque tracer medium, to facilitate radiography of the fallopian tubes/uterus.

B

54

Intrauterine imaging medium catheterization kit

Sterile devices intended for the intrauterine injection of an opaque tracer medium, to facilitate radiography of the fallopian tubes/uterus.

B

55

(a) Laparoscope laser coupler

To connect the laparoscope to the laser or the laser arm for laparoscopic laser treatment.

B

(b) Laparoscope laser adaptor

A

56

Laparoscope system

For the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs (laparoscopy).

B

57

Laparoscope system, reusable or single use

For the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs (laparoscopy).

B

58

Manual expandable cervical dilator

To dilate the cervical canal with a balloon when the uterine does not dilate enough due to inertia.

B

59

Mechanical foetal heart simulator

To imitate a foetal heart (e.g., foetal heart ultrasound signals) when used in combination with foetal/maternal multiple physiological parameter simulator in order to test foetal monitoring and recording equipment [e.g., cardiotocography (CTG)], check patient cable continuity, or to train healthcare providers.

B

60

Papanicolaou smear kit or Endometrial sampling kit

Used to collect and prepare pap smears samples in a medical institute.

B

61

Pelvic examination kit

For performing pelvic examination

B

62

Pelvimeter

A measuring device used to determine the pelvic dimensions.

B

63

Pelviscope

An endoscope used for visual examination and diagnosis of pelvis.

B

64

Perineal warmer

It is useful for pain relief in the vulva after episiotomy.

B

65

Perineometer

To determine perineal muscle strength through resistance to spontaneous contraction of perineal muscle. Also used to diagnose and treat urinary incontinence and sexual dysfunction through movement.

B

66

Pudendal anaesthesia kit

A collection of sterile devices designed to deliver anaesthetic agent to the external genitalia of humans.

B

67

Resectoscope

An endoscope used for visual examination, diagnosis and treatment, especially for resection of tissues.

B

68

Rigid culdoscope

An endoscope with a rigid inserted portion intended for the visual examination and treatment of the female peritoneal cavity and organs.

B

69

Rigid fibreoptic hysteroscope

An endoscope with a rigid inserted portion intended for the visual examination and treatment of the canal of the cervix and the uterine cavity (uterus).

B

70

Rigid mammary ductoscope

An endoscope with a rigid inserted portion intended for the visual examination and treatment of the mammary duct

B

71

Rigid optical laparoscope

An endoscope with a rigid inserted portion intended for the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs.

B

72

Rigid salpingoscope

An endoscope with a rigid inserted portion intended for the visual examination and treatment of the fallopian tubes (oviducts)

B

73

Rigid ultrasound laparoscope

An endoscope with a rigid inserted portion, combined with an ultrasound probe, intended for the visual examination, treatment, and ultrasonic imaging of the abdominal/retroperitoneal cavity and its organs

B

74

Rigid video hysteroscope

Active device intended to allow visual examination and treatment of the canal of the cervix and the uterine cavity (uterus).

B

75

Rigid video laparoscope

An endoscope with a rigid inserted portion intended for the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs

B

(a) Suprapubic needle, surgical, reusable

Percutaneously puncture the lower abdominal wall to provide suprapubic access for surgical repair.

B

(b) Suprapubic needle, surgical, single use/ disposable

B

76

Uterine injector

Used to inject liquid, drug, or other substance into the uterus. It is a reusable device.

B

77

Uterine manipulator cervical cup/transilluminator

Allow manipulation of the uterus under suction whilst preventing laparoscopic insufflation gas from escaping from the cervix (during hysterectomy).

B

78

(a) Uterine manipulator, reusable

Surgical instrument designed to mechanically manipulate the position of the uterus during a gynaecological intervention

B

(b) Uterine manipulator, single use/disposable

B

79

(a) Uterine probe, reusable

For exploring the uterus during a surgical procedure. Used as a component of a uterine manipulator

B

(b) Uterine probe, single use/disposable

For exploring the uterus during a surgical procedure. Used as a component of a uterine manipulator

B

80

Uterus-supporting pessary

Inserted into the vagina to hold the uterus in place.

B

81

Vaginal douche, reusable or single use

A device designed to apply medication to the vagina.

A

82

(a) Vaginal dilator, reusable

Inserted into the vagina to dilate a narrow vaginal opening due to congenital defect. Can be used during examination, treatment or surgical procedure.

B

(b) Vaginal dilator, single use/ disposable

To deliver a liquid (usually solution) directly into the vaginal cavity for hygienic purpose as a douche.

B

83

Vaginal douche, reusable or single use

To deliver a liquid (usually solution) directly into the vaginal cavity for hygienic purposes as a douche.

B

84

Vaginometer

A device that measures the length and diameter of vagina.

A

85

Vaginoscope

For paediatric vaginal examination. To search foreign matter or bleeding sites.

B

86

Viscera retention paddle or Visceral retainer

Used to hold an organ at proper position (i.e., viscera) while the surgeon performs a suturing procedure (typically internal wound closure). It is also implanted into a surgical site temporarily.

B

87

Amniotic membrane perforator, reusable

A surgical instrument used to rupture the amniotic membrane to assist in childbirth, without causing injury to the mother or foetus

A

88

Amniotome, reusable

A surgical instrument used to rupture the amniotic membrane to assist in childbirth, without causing injury to the mother or foetus

B

89

Bladder-supporting pessary

Inserted into the vagina to facilitate management of female urinary incontinence and/or to reduce bladder prolapse.

B

90

Catheter-tip transducer, pressure

A device intended to be incorporated into the distal end of a catheter (not included) to measure pressure.

B

91

Foetal Doppler system probe

Placed on the surface of a pregnant woman’s abdomen to detect foetal heart beats using ultrasonic/Doppler technology.

C

92

Preservation medium for human semen

It is intended for cryopreservation of human semen for later use in Assisted Reproductive procedure. It may include medicinal and biological components like glycerol, gentamicin, Test Yolk Buffer (TYB),etc.

C

93

Sperm cryopreservation medium

It is intended for use in Assisted Reproductive procedures involving the cryopreservation and storage of semen.

C

94

Vitrification freezing kit

It is intended for use in Assisted Reproductive procedure for vitrification and storage of human oocytes (MII), Pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos. It may include medicinal and protein supplements like Gentamicin, Dextran Serum Supplement(DSS), etc.

C

95

Vitrification Thawing/Warming kit

Intended for use in the thawing of vitrified oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos that have been vitrified using vitrification freeze kit.It may include medicinal and protein supplements like Gentamicin, Dextran Serum Supplement(DSS), etc.

C

96

Handling medium

Intended for use in Assisted reproductive procedure which involves manipulation of gametes or embryos. Specially, it is indicated for use as an oocyte retrieval medium during ovarian follicle aspiration procedure, washing sperm prior to IVF and ICSI (Intra Cytoplasmic sperm injection) fertilization procedures, and for transport of the embryo to the uterus during embryo transfer procedure. It may include medicinal and protein supplements like Gentamicin, Human Serum Albumin (HSA), etc.

C

97

Gamete and embryo retrieval, storage and transfer medium

Used in Assisted reproductive procedure which includes retrieval, culture, transport,storage, handling, and transfer of human gametes and embryos by creating a physiological environment. It may include buffer solution and medicinal substances like Gentamicin, etc.

C

98

Hyaluronidase solution

Intended for use in removing cumulus cells surrounding oocytes (denudation) in preparation for ICSI (Intra cytoplasmic sperm injection) or other Assisted reproductive procedures. It is a 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.

C

99

Polyvinylpyrrolidone (PVP) Solution

Used in Assisted reproductive procedure which include human gamete and embryo manipulation. It uses PVP solution for immobilizing sperm for ICSI (Intra cytoplasmic sperm injection) procedures.This solution may include protein supplements like Human Serum Albumin (HSA), etc.

C

100

Sperm Separation Medium

It is intended for separation of the motile fraction of sperm from seminal fluid. It works on the principle of isopycnic separation.

B

101

Sperm processing media

Designed to maintain sperm quality on the table top without CO2 incubation. This procedure includes use of this medium for sperm washing by supporting all steps of sperm preparation prior to fertilization. It may contain protein supplements like human serum albumin (HSA), bovine serum albumin, etc.

C

102

Water for Assisted Reproductive Technologies

Intended for use in ART Laboratories procedure requiring a nonpyrogenic high quality pure grade of water.

B

103

In Vitro embryo Culture medium, through day 5/6 of development

It is intended for use in assisted reproductive procedures which include gamete and embryo manipulation. It is used as a culture medium for human gametes and embryos from fertilization through day 5/6 of development. It may include medicinal substances like Gentamicin and protein supplements like Human serum Albumin (HSA), etc.

C

104

In Vitro embryo culture medium, through day 3 of development

This medium is intended for use in assisted reproductive procedures which include human gamete and embryo manipulation. It is used as a culture medium through day 3 of development. It may be used as a stand-alone medium, or as the first stage of a sequential medium protocol. It may include medicinal substances like Gentamicin, etc.

C

105

Protein supplement for in vitro embryo culture

For use in assisted reproductive procedures which include gamete and embryo manipulation, as a supplement for culture media. It may include protein supplements like Human Serum Albumin (HSA), Synthetic Serum Substitute (SSS), Dextran Serum Supplement (DSS), etc. Not for use as an injectable product.

B

106

Oil for embryo culture

It is used as an overlay to cover small volumes of culture media during human embryo and gamete manipulation to prevent evaporation of culture media.

B

107

Menstrual Cup

Placed in the vagina to collect blood and cellular debris discharges during menstruation and discharges outside of the monthly menses.

B

108

Birthing bed/table, powered

Bed used during labor and delivery.

A (Non-Notified)

109

Gynaecological bib

A piece of cloth worn by the patient.

A (Non-Notified)

110

Gynaecological examination/treatment table

To support a woman’s body in the appropriate positions during gynaecological examinations.

A (Non-Notified)

111

Gynaecological operating table top

A component of a modular operating table designed as a detachable table top constructed for gynaecological surgical procedures.

A (Non-Notified)

112

Gynaecological operating table, electrohydraulic or electromechanical or hydraulic

Active device designed to support a patient during gynaecological surgical procedures

A (Non-Notified)

113

Gynaecological surgical microscope

To improve visualization of anatomical structures via transmitted light during gynaecological surgery (e.g., on the fallopian tubes).

A (Non-Notified)

114

Heel stirrup

A device used during a medical/surgical procedure to steadily hold a patient’s foot (feet) by cradling the heel or the whole foot.

A (Non-Notified)

115

Umbilical ligator

Surgical device used for umbilical cord ligation.

A (Non-Notified)

116

Uterine packer

A hand-held, surgical instrument used to introduce dressings into the uterus or vagina. This is a reusable device.

A (Non-Notified)