Introduction:
This article deals with the latest rules of ENTas a Medical Device in India – Non Notified Medical Device Registration. Indian healthcare regulators at the Central Drugs Standard Control Organization (CDSCO) have issued substantial new risk-based classification lists for ENT and Medical Device in India. All ENT 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 67.
Table: ENT as Medical Device in India
| Sr.No. | Medical Device Name | Intended Use | RiskClass |
| 1 | Adenotome | Surgical instrument intended to dissect theadenoids. | A |
| 2 | Adenotome blade | Intended to mount on adenotome and performdissection of adenoids. | B |
| 3 | Audiometer testing system | An assembly of electronic reference devicesintended to calibrate an audiometer. | A |
| 4 | Audiometer | Intended for evaluation of hearing by generatingtones throughout the audible range | B |
| 5 | Evoked response auditorystimulator | An evoked response auditory stimulator is adevice that produces a sound stimulus for use inevoked response measurements orelectroencephalogram activation. | B |
| 6 | Behind-the-ear air-conduction hearing aid | Intended to compensate for impaired hearing bytransmitting amplified sound waves to the eardrumthrough air. | B |
| 7 | Behind-the-ear air-conduction tinnitus masker | Intended to provide noise of sufficient intensity andbandwidth to mask tinnitus. | B |
| 8 | Behind-the-ear bone-conduction tinnitus masker | Intended to provide ultrasonic broadband noiseand/or sweep-frequency stimuli noise of sufficientintensity and bandwidth to mask tinnitus. | C |
| 9 | Cochlear implantassessment system | Intended to perform an integrity test on theimplantable portion of a cochlear implant (CI)system in-situ. | C |
| 10 | Ear bowl | Constructed to fit the curvature of the head so thatit will sit closely under the ear lobe and enabletreatments of ear. | A |
| 11 | Ear canal impression tray | Intended to hold and confine the impressionmaterial in opposition to the surfaces to berecorded, and to control the impression materialwhile it sets to form the impression of the earcanal. | A |
| 12 | Ear canal light | Intended to illuminate the ear canal. | A |
| 13 | Ear excavator | Designed for cutting, scraping, scooping andremoving tissue during a surgical procedure in oraround the ear. | A |
| 14 | Ear prosthesis | Intended to reconstruct the external ear byreplacing damaged or missing tissue. | C |
| 15 | Ear wick | Intended to minimize bleeding during ear surgery. | A |
| 16 | Electroglottograph | Intended for recording the changes in electricalpotential or impedance, resulting from movementof the vocal cords during respiration andphonation. | B |
| 17 | Endaural curette | Designed for scraping within the ear canal (e.g.,removing wax), and for procedures during middleear surgery (e.g., removal of the superior bonyrim). | A |
| 18 | ENT chair, electric | Designed to support a patient in a seated position,electrically control position in a way to facilitateear, nose, throat examination, treatment, and/orminor surgery. | A |
| 19 | ENT chair, mechanical | Designed to support a patient in a seated position,mechanically control position in a way to facilitateear, nose, throat examination, treatment, and/orminor surgery. | A |
| 20 | ENT shaver system | Intended to resect/debride soft and osseous(bone) tissue in the nasal cavity or ear regionduring ear/nose/throat (ENT) or plastic surgeryprocedures; including functional endoscopic sinussurgery (FESS). | B |
| 21 | ENT surgical microscope | Intended to magnify minute structures (e.g.,nerves, vessels) in the performance of ear, nose,and/or throat (ENT) surgery requiring highmagnification and adjustable focusing. | A |
| 22 | ENT transilluminator | Intended to illuminate sinus tissue during anear/nose/throat (ENT) procedure to render thetissue translucent for examination | A |
| 23 | Evoked-potential audiometer | Electroacoustic instrument designed to evaluatethe activity of the auditory pathway of the brain inresponse to an acoustic signal [auditory brainstemresponse (ABR)] in patients. | B |
| 24 | Flexible fibreopticnasopharyngo laryngoscope | Flexible endoscope intended for the visualexamination and treatment of the nasal passages,including the sinus openings, the pharyngeal endof the auditory tube, the larynx, and the vocalcords. | B |
| 25 | Flexible fibreopticnasopharyngoscope | Flexible endoscope intended for the visualexamination and treatment of nasopharynx (theupper part of the throat behind the nose). | B |
| 26 | Flexible fibreoptic rhinoscope | Flexible endoscope intended for the visualexamination and treatment of nasal cavity. | B |
| 27 | Flexible fibreoptic sinoscope | Flexible endoscope intended for the visualexamination and treatment of the paranasalsinuses during an ear/nose/throat (ENT)intervention. | B |
| 28 | Flexible video antroscope | Flexible endoscope intended for the visualexamination and treatment of a cavity, particularlythe pathological changes in the area of themaxillary sinus. | B |
| 29 | Impedance audiometer | Intended to evaluate the functional condition of themiddle ear by changing the air pressure in theexternal auditory canal to measure and graph themobility characteristics of the tympanic membrane. | B |
| 30 | Nasal septum straighteningforceps | Surgical instrument specifically designed tostraighten the nasal septum through grasping andmanipulation of the bone/cartilage of the septumduring nasal reconstructive procedures. | A |
| 31 | Otoscope, endoscopic | Intended to be used in otology mainly forobservation, diagnosis, and treatment of the outerand/or middle ear. | A |
| 32 | Tonsil knife | Intended for the removal of the tonsils during asurgical intervention. | A |
| 33 | Tracheal bistoury | Designed for opening abscesses or slitting upsinuses and/or fistulas in the trachea. | A |
| 34 | Middle ear mold | A middle ear mold is a preformed device that isintended to be implanted to reconstruct the middleear cavity during repair of the tympanicmembrane. | C |
| 35 | Fully-implantable middle earimplant system | An implanted assembly of sterile devices intendedto compensate for impaired hearing by transmittingvibrations to the middle ear. It is powered by abattery that is recharged inductively, via anexternal device. | C |
| 36 | Larynx prosthesis | A device used for replacement and restoration ofthe laryngeal function, or for maintenance ofpatency of the larynx. | C |
| 37 | Epistaxis balloon | Device intended to control internal nasal bleedingby exerting pressure against the sphenopalatineartery. | B |
| 38 | Eustachian tube balloondilation system | The system is intended for use in dilating thecartilaginous portion of the Eustachian tube fortreating persistent Eustachian tube dysfunction. | B |
| 39 | Argon laser for otology,rhinology, and laryngology | Device is used for the purpose of coagulating andvaporizing soft and fibrous tissues, includingosseous tissue while performing ENT surgicalprocedure. | C |
| 40 | Ear, nose, and throatmicrosurgical carbon dioxidelaser | Device intended for the surgical excision of tissuefrom the ear, nose, and throat area whileperforming microsurgical procedures to exciselesions and tumors of the vocal cords and adjacentareas. | C |
| 41 | Esophagoscope (flexible orrigid) | Device intended to examine or treat esophagealmalfunction symptoms, esophageal or mediastinaldisease, or to remove foreign bodies from theesophagus. | B |
| 42 | Mediastinoscope andaccessories | Device intended to examine or treat tissue in thearea separating the lungs for diagnosis of tumorsand lesions and to determine whether excision ofcertain organs or tissues is indicated. | B |
| 43 | Laryngostroboscope | A laryngostroboscope is a device that is intendedto allow observation of glottic action duringphonation. | B |
| 44 | Bone particle collector | A bone particle collector is a filtering deviceintended to be inserted into a suction tube duringthe early stages of otologic surgery to collect boneparticles for future use. | A |
| 45 | Suction antichoke device | A suction antichoke device is a device intended tobe used in an emergency situation to remove, bythe application of suction, foreign objects thatobstruct a patient’s airway to prevent asphyxiationto the patient. | C |
| 46 | Tongs antichoke device | A tongs antichoke device is a device that isintended to be used in an emergency situation tograsp and remove foreign objects that obstruct apatient’s airway to prevent asphyxiation of thepatient. | C |
| 47 | Powered nasal irrigator | A powered nasal irrigator is an AC-powered deviceintended to wash the nasal cavity by means of apressure-controlled pulsating stream of water. | B |
| 48 | External nasal splint | An external nasal splint is a rigid or partially rigiddevice intended for use externally forimmobilization of parts of the nose. | A |
| 49 | Antistammering device | An antistammering device intended to minimize auser’s involuntary hesitative or repetitive speech. Italso prevent the user from hearing the sounds ofhis or her own voice | B |
| 50 | External upper esophagealsphincter compressiondevice | An external upper esophageal sphinctercompression device is intended to apply externalpressure on the cricoid cartilage for the purpose ofreducing the symptoms of laryngopharyngealreflux disease. | C |
| 51 | Wireless air-conductionhearing aid | A wireless air-conduction hearing aid is intendedto compensate for impaired hearing thatincorporates wireless technology in itsprogramming or use. | B |
| 52 | Hearing aid calibrator andanalysis system | A hearing aid calibrator and analysis system is anelectronic reference device intended to calibrateand assess the electroacoustic frequency andsound intensity characteristics emanating from ahearing aid, master hearing aid, group hearing aidor group auditory trainer. | B |
| 53 | Tympanic membrane contacthearing aid | A tympanic membrane contact hearing aid is aprescription device that compensates for impairedhearing by vibrating the tympanic membranethrough a transducer that is in direct contact withthe tympanic membrane. | B |
| 54 | Master hearing aid | A master hearing aid is an electronic deviceintended to simulate a hearing aid duringaudiometric testing. | B |
| 55 | Active implantable boneconduction hearing system | The active implantable bone conduction hearingsystem is intended to compensate for conductiveor mixed hearing losses by conveying amplifiedacoustic signals to the cochlea via mechanicalvibrations on the skull bone. | C |
| 56 | Battery-powered artificiallarynx | A battery-powered artificial larynx is an externallyapplied device intended for use in the absence ofthe larynx to produce sound. | B |
| 57 | Nasal dilator | A nasal dilator is a device intended to providetemporary relief from transient causes of breathingdifficulties resulting from structural abnormalitiesand/or transient causes of nasal congestionassociated with reduced nasal airflow. | A |
| 58 | Transcutaneous airconduction hearing aidsystem | A transcutaneous air conduction hearing aidsystem is a wearable sound-amplifying deviceintended to compensate for impaired hearingwithout occluding the ear canal. | C |
| 59 | Acoustic chamber foraudiometric testing | An acoustic chamber for audiometric testing is aroom that is intended for use in conductingdiagnostic hearing evaluations and that eliminatessound reflections and provides isolation fromoutside sounds. | A |
| 60 | Gustometer | A gustometer is a battery-powered device thatconsists of two electrodes that are intended toprovide galvanic stimulus resulting in tastesensation. | B |
| 61 | ENT cupped forceps | A forcep with a spoon-(dish) like configuration atthe distal end, and is used to treat the ear, nose,and throat (ENT), and remove tissue from thebody. | A |
| 62 | Tongue depressor | A surgical instrument used to move the tongue tofacilitate examination of surrounding organs andtissue. | A |
| 63 | Tonsillectome | A manually operated surgical device used todissect the tonsils. | A |
| 64 | ENT Nasal snare | A hand-held manual surgical instrument intendedto be inserted into the naris for the removal oftissue, typically polyps, tumours, and otherabnormal tissue from the nasal cavity duringear/nose/throat (ENT) surgery | A |
| 65 | Otoscope, direct | A portable, battery-powered, hand-held device(non-endoscopic) primarily designed forexamination of the outer ear canal and tympanicmembrane (eardrum) by direct viewing through theear opening. | A |
| 66 | Soft-tissue surgical forceps,alligator | A long, thin, hand-held manual surgical instrumentdesigned to facilitate grasping and manipulation ofsoft-tissues/anatomical structures [typically duringear/nose/throat (ENT) surgery]. | A |
| 67 | Ear, nose, and throat electricor pneumatic surgical drill | An ear, nose, and throat electric or pneumaticsurgical drill is a rotating drilling device, includingthe handpiece, that is intended to drive variousaccessories, such as an ear, nose, and throat burfor the controlled incision or removal of bone in theear, nose, and throat area. | 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 ENT as a Medical Device India. In order to comply with the 30th September of ENT as a Medical Device in India contact us at [email protected]. You can also subscribe to our website to learn about the Latest Rules and Medical Regulations.