Introduction – Obstetrical and Gynecological as Medical Device India
This article deals with the latest rules of Obstetrical and Gynecological Products as a Medical Device India – Non Notified Medical Device Registration. (List is updated on 3rd June, 2022) Indian healthcare regulators at the Central Drugs Standard Control Organization (CDSCO) have issued substantial new risk-based classification lists for Obstetrical and Gynecological Products as a Medical Device India. All Obstetrical and Gynecological Products now need to be registered in order to comply with the latest Medical Device Rules in India ( i.e 30th September, 2021). Below is a table which helps manufacturers classify their products and apply with the Indian Health Ministry Accordingly. The total number of Devices classified are 123
Table: Obstetrical and Gynecological As Medical Device India
Medical Device India
| Sr.No. | DEVICE NAME | 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 | Birthing bed/table, powered | Bed used during labor and delivery. | A |
| 5 | Cardiotocography | A device that records fetal heart rate and uterine contraction simultaneously. | C |
| 6 | Cardiotocograph transducer | A device that converts birthing contractions to electrical signals and is used together with cardiotocography (CTG) which displays the signals. | C |
| 7 | Cardiotocography telemetric monitoring system | An assembly of devices intended to be used to continuously measure and wirelessly transmit foetal heart rate and uterine contraction signals from a patient to a monitor. | C |
| 8 | 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 |
| 9 | Cardiotocography telemetric monitoring system transmitter | It transmits signals related to fetal heart rate and uterine contractions to the receiver. | C |
| 10 | 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 |
| 11 | 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 |
| 12 | Colposcope | Special microscope for examination of female genital organs (e.g., vagina, cervix). | B |
| 13 | Contraceptive cervical cap, reusable or single use | Device inserted into the cervix to prevent semen from entering the uterus. | C |
| 14 | 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 |
| 15 | Contraceptive sponge | Bubble-like devices work as a physical barrier to prevent spermatic invasion into the uterus. | C |
| 16 | Diaphragm pessary | A circular device placed in the vagina prior to intercourse to mechanically prevent conception. | C |
| 17 | Endocervical aspirator | A collection of devices designed to remove superficial tissue from the mucous membrane lining the cervical canal (endometrium) through manually-powered suction. | B |
| 18 | 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 |
| 19 | (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 | ||
| 20 | Endometrial biopsy kit | For the collection of a tissue sample taken from the lining of the uterus (endometrium). | B |
| 21 | Endometrial cytology brush | A brush used to collect mucosal cell for pathological diagnosis during endoscopic examination. | B |
| 22 | 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 |
| 23 | 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 |
| 24 | 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 |
| 25 | 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 |
| 26 | (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 | B | ||
| 27 | Flexible fibreoptic culdoscope | Flexible endoscope for visual examination, diagnosis, and treatment of urinary bladder and urethra. | B |
| 28 | Flexible fibreoptic hysteroscope | For the visual examination and treatment of the canal of the cervix and the uterine cavity (uterus). | B |
| 29 | Flexible fibreoptic laparoscope | For the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs | B |
| 30 | Flexible fibreoptic mammary ductoscope | For the visual examination and treatment of the mammary duct. | B |
| 31 | Flexible fibreoptic salpingoscope | For the visual examination and treatment of the fallopian tubes (oviducts). | B |
| 32 | Flexible ultrasound laparoscope | For the visual examination, treatment, and ultrasonic imaging of the abdominal/retroperitoneal cavity and its organs. | B |
| 33 | Flexible video culdoscope | For the visual examination and treatment of the female peritoneal cavity and organs. | B |
| 34 | Flexible video hysteroscope | For the visual examination and treatment of the canal of the cervix and the uterine cavity (uterus). | B |
| 35 | Flexible video laparoscope | For the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs. | B |
| 36 | Flexible video mammary ductoscope | For the visual examination and treatment of the mammary duct. | B |
| 37 | Flexible video salpingoscope | For the visual examination and treatment of the fallopian tubes (oviducts). | B |
| 38 | Foetal acoustic stimulator | Uses sound stimuli to assess foetal well-being. This device is used to evaluate the status of the foetus as expressed by, e.g., foetal heart rate changes or foetal acid-base status, in antepartum tests and/or during intrapartum monitoring. | B |
| 39 | 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 |
| 40 | Foetal blood sampler | Invasive device to collect fetal blood through uterine cervix. | B |
| 41 | Foetal cardiac monitor | Active device designed to detect, measure, and display foetal heart activity during the perinatal period | C |
| 42 | Foetal pleuro-amniotic catheter | Sterile implantable device used to continuously drain fetal pleural effusion to maternal amniotic cavity. | C |
| 43 | Foetal scalp electrode, clip | Placed directly on the scalp of the fetus in the uterus to monitor fetal vital signs. | C |
| 44 | Foetal stethoscope | Mechanical hearing device used to listen to fetal heartbeat. | A |
| 45 | Foetal vacuum extraction cup, reusable or single use | A device used to extract the head of the fetus with a vacuum cup. | B |
| 46 | 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 |
| 47 | Foetal vacuum extraction system, manual, reusable or single use | To facilitate the delivery of a foetus during vaginal childbirth or Caesarean. | B |
| 48 | Foetal vacuum extraction system, pneumatic | To facilitate the delivery of a foetus during vaginal childbirth or Caesarean. | B |
| 49 | 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 |
| 50 | 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 |
| 51 | Gynaecological bib | A piece of cloth worn by the patient. | A |
| 52 | Gynaecological examination/treatment table | To support a woman’s body in the appropriate positions during gynaecological examinations. | A |
| 53 | Gynaecological operating table top | A component of a modular operating table designed as a detachable table top constructed for gynaecological surgical procedures. | A |
| 54 | Gynaecological operating table, electrohydraulic or electromechanical or hydraulic | Active device designed to support a patient during gynaecological surgical procedures | A |
| 55 | (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 | ||
| 56 | Gynaecological surgical microscope | To improve visualization of anatomical structures via transmitted light during gynaecological surgery (e.g., on the fallopian tubes). | A |
| 57 | 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 |
| 58 | Hysteroscopic insufflator | A device that sends the gas into the fallopian tube to maintain the patency of the tubes. | B |
| 59 | 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 |
| 60 | (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 | ||
| 61 | 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 |
| 62 | Intrauterine haemostatic suction catheter | Inserted into the uterus to reduce postpartum bleeding through aspiration of blood/debris and induction of uterine contractions. | B |
| 63 | Intrauterine imaging medium catheter | Intrauterine injection of an opaque tracer medium, to facilitate radiography of the fallopian tubes/uterus. | B |
| 64 | 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 |
| 65 | (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 | ||
| 66 | Laparoscope system | For the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs (laparoscopy). | B |
| 67 | Laparoscope system, reusable or single use | For the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs (laparoscopy). | B |
| 68 | Manual expandable cervical dilator | To dilate the cervical canal with a balloon when the uterine does not dilate enough due to inertia. | B |
| 69 | 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 |
| 70 | Motorized laparoscopic forceps | Active surgical instrument designed for grasping, mobilizing, and suturing tissues/vessels under direct or endoscopic visualization during a surgical procedure. | B |
| 71 | Papanicolaou smear kit or Endometrial sampling kit | Used to collect and prepare pap smears samples in a medical institute. | B |
| 72 | Pelvic examination kit | For performing pelvic examination | B |
| 73 | Pelvimeter | A measuring device used to determine the pelvic dimensions. | B |
| 74 | Pelviscope | An endoscope used for visual examination and diagnosis of pelvis. | B |
| 75 | Perineal warmer | it is useful for pain relief in the vulva after episiotomy. | B |
| 76 | 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 |
| 77 | Pudendal anaesthesia kit | A collection of sterile devices designed to deliver anaesthetic agent to the external genitalia of humans. | B |
| 78 | Resectoscope | An endoscope used for visual examination, diagnosis and treatment, especially for resection of tissues. | B |
| 79 | Rigid culdoscope | An endoscope with a rigid inserted portion intended for the visual examination and treatment of the female peritoneal cavity and organs. | B |
| 80 | 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 |
| 81 | Rigid mammary ductoscopy | An endoscope with a rigid inserted portion intended for the visual examination and treatment of the mammary duct | B |
| 82 | 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 |
| 83 | Rigid salpingoscope | An endoscope with a rigid inserted portion intended for the visual examination and treatment of the fallopian tubes (oviducts) | B |
| 84 | 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 |
| 85 | Rigid video hysteroscope | Active device intended to allow visual examination and treatment of the canal of the cervix and the uterine cavity (uterus). | B |
| 86 | 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 | ||
| 88 | Umbilical ligator | Surgical device used for umbilical cord ligation. | A |
| 89 | Uterine injector | Used to inject liquid, drug, or other substance into uterus. It is a reusable device. | B |
| 90 | 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 |
| 91 | (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 | ||
| 92 | Uterine packer | A hand-held, surgical instrument used to introduce dressings into the uterus or vagina. This is a reusable device. | A |
| 93 | (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 | |
| 94 | Uterus-supporting pessary | Inserted into the vagina to hold the uterus in place. | B |
| 95 | Vaginal applicator, reusable or single use | A device designed to apply medication to the vagina. | A |
| 96 | (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 | B | ||
| 97 | Vaginal douche, reusable or single use | To deliver a liquid (usually solution) directly into the vaginal cavity for hygienic purposes as a douche. | B |
| 98 | Vaginometer | A device that measures the length and diameter of vagina. | A |
| 99 | Vaginoscope | For paediatric vaginal examination. To search foreign matter or bleeding site. | B |
| 100 | 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 |
| 101 | Breast transilluminator | Active device transmitted through the female breast to visualize translucent tissue for the diagnosis of cancer, or other conditions, diseases or abnormalities. | C |
| 102 | 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 |
| 103 | Amniotome, reusable | A surgical instrument used to rupture the amniotic membrane to assist in childbirth, without causing injury to the mother or foetus | B |
| 104 | Bladder-supporting pessary | Inserted into the vagina to facilitate management of female urinary incontinence and/or to reduce bladder prolapse. | B |
| 105 | Catheter-tip transducer, pressure | A device intended to be incorporated into the distal end of a catheter (not included) to measure pressure. | B |
| 106 | Foetal Doppler system | Active non-invasive device to detect foetal heart beats using ultrasound/Doppler technology. | C |
| 107 | Foetal Doppler system probe | Placed on the surface of a pregnant woman’s abdomen to detect foetal heart beats using ultrasonic/Doppler technology. | C |
| 108 | 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 |
| 109 | Sperm cryopreservation medium | It is intended for use in Assisted Reproductive procedure involving the cryopreservation and storage of semen. | C |
| 110 | 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 |
| 111 | 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 |
| 112 | Handling medium | Intended for use in Assited reproductive procedure which involves manipulation of gametes or embryos. Specially, it is indicated for use as an oocyte retrival 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 utreus during embryo transfer procedure. It may include medicinal and protein supplements like Gentamicin, Human Serum Albumin (HSA), etc. | C |
| 113 | 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 substance like Gentamicin, etc. | C |
| 114 | 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 |
| 115 | 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 supplement like Human Serum Albumin (HSA), etc. | C |
| 116 | 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 |
| 117 | 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 contains protien supplements like human serum albumin (HSA), bovine serum albumin, etc. | C |
| 118 | Water for Assisted Reproductive Technologies | Intended for use in ART Laboratories procedure requiring a nonpyrogenic high quality pure grade of water. | B |
| 119 | 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 substance like Gentamicin and protein supplement like Human serum Albumin (HSA), etc. | C |
| 120 | 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 substance like Gentamicin, etc. | C |
| 121 | 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 supplement like Human Serum Albumin (HSA), Synthetic Serum Substitute (SSS), Dextran Serum Supplement (DSS), etc. Not for use as an injectable product. | B |
| 122 | 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 |
| 123 | Menstrual Cup | Placed in the vagina to collect blood and cellular debris discharges during menstruation and discharges outside of the monthly menses. | B |
Conclusion:
The above article is taken from S.O 648(E) & G.S.R 102(E) which mentions that all Medical Devices will be regulated in a phase manner. The CDSCO has classified the MDR in India as Appendix A based on the Intended Use, Risks Associated and Other Parameters Specified with the device. The above table has the general intended use against each device, however if any specific intended use for a particular device, it has to be mentioned by the manufacturer. The list is dynamic and is subject to changes. To obtain MDR in India, contact Morulaa. We at Morulaa will help you understand the latest rules for Obstetrical and Gynecological As a Medical Device India. We are a turnkey solution provider with an in-house Medical Device Consultancy team to conduct registrations of Medical Devices in India. In order to comply with the Deadline 30th September of Obstetrical and Gynecological as a Medical Device in India contact us at admin@morulaa.com. You can also subscribe to our website to learn about the Latest Rules and Medical Regulations.
Leave a reply
You must be logged in to post a comment.