India Risk Classification for ENT as Medical Device
CDSCO Registration ENT Devices | Medical Device Compliance in India
Introduction CDSCO Guidelines for ENT devices
The following article highlights how ENT falls under the category of Medical Device and its regulation under the Medical Devices Rules 2017 for ENT devices in India. Guidelines have been issued by the CDSCO for medical devices, including the classification of Class A medical devices as low risk and Self Notified. Even though these medical devices are low risk, they still have to abide by the CDSCO registration ENT devices in India requirements.
India is Updating Existing Risk Based Classifications for ENT as Medical Device
As per the recent notification MED 16014(12)/1/2024 eOffice, dated January 6, 2025, 15 medical devices falling under this category have been downgraded from Class A to Class A (Self Notified). This has made it easier for the manufacturers to comply and has been done in accordance with the Indian CDSCO medical device registration process. The complete list of all such reclassified devices is given below with changes shown in dark grey.
Table: ENT Medical Device Regulatory Approval India
S.No | Device Name as per Medical Device Rules in India | Intended Use | Risk Class |
1 | Adenotome | Surgical instrument intended to dissect the adenoids. | A |
2 | Adenotome blade | Intended to mount on adenotome and perform dissection of adenoids. | B |
3 | Audiometer testing system | An assembly of electronic reference devices intended to calibrate an audiometer. | A |
4 | Audiometer | Intended for evaluation of hearing by generating tones throughout the audible range | B |
5 | Evoked response auditory stimulator | An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation. | B |
6 | Behind the ear air conduction hearing aid | Intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. | B |
7 | Behind the ear air conduction tinnitus masker | Intended to provide noise of sufficient intensity and bandwidth to mask tinnitus. | B |
8 | Behind the ear bone conduction tinnitus masker | Intended to provide ultrasonic broadband noise and/or sweep frequency stimuli noise of sufficient intensity and bandwidth to mask tinnitus. | C |
9 | Cochlear implant assessment system | Intended to perform an integrity test on the implantable portion of a cochlear implant (CI)system in situ. | C |
10 | Ear excavator | Designed for cutting, scraping, scooping and removing tissue during a surgical procedure in or around the ear. | A |
11 | Ear prosthesis | Intended to reconstruct the external ear by replacing damaged or missing tissue. | C |
12 | Electroglottograph | Intended for recording the changes in electrical potential or impedance, resulting from movement of the vocal cords during respiration and phonation. | B |
13 | Endaural curette | Designed for scraping within the ear canal (e.g.,removing wax), and for procedures during middle ear surgery (e.g., removal of the superior bonyrim). | A |
14 | ENT shaver system | Intended to resect/debride soft and osseous(bone) tissue in the nasal cavity or ear region during ear/nose/throat (ENT) or plastic surgery procedures; including functional endoscopic sinus surgery (FESS). | B |
15 | Evoked potential audiometer | Electroacoustic instrument designed to evaluate the activity of the auditory pathway of the brain in response to an acoustic signal [auditory brainstem response (ABR)] in patients. | B |
16 | Flexible fibreoptic nasopharyngo laryngoscope | Flexible endoscope intended for the visual examination and treatment of the nasal passages,including the sinus openings, the pharyngeal end of the auditory tube, the larynx, and the vocal cords. | B |
17 | Flexible fibreoptic nasopharyngoscope | Flexible endoscope intended for the visual examination and treatment of nasopharynx (the upper part of the throat behind the nose). | B |
18 | Flexible fibreoptic rhinoscope | Flexible endoscope intended for the visual examination and treatment of nasal cavity. | B |
19 | Flexible fibreoptic sinoscope | Flexible endoscope intended for the visual examination and treatment of the paranasal sinuses during an ear/nose/throat (ENT)intervention. | B |
20 | Flexible video antroscope | Flexible endoscope intended for the visual examination and treatment of a cavity, particularlythe pathological changes in the area of themaxillary sinus. | B |
21 | Impedance audiometer | Intended to evaluate the functional condition of the middle ear by changing the air pressure in the external auditory canal to measure and graph the mobility characteristics of the tympanic membrane. | B |
22 | Tonsil knife | Intended for the removal of the tonsils during a surgical intervention. | A |
23 | Tracheal bistoury | Designed for opening abscesses or slitting upsinuses and/or fistulas in the trachea. | A |
24 | Middle ear mold | A middle ear mold is a preformed device that is intended to be implanted to reconstruct the middle ear cavity during repair of the tympanic membrane. | C |
25 | Fully implantable middle ear implant system | An implanted assembly of sterile devices intended to compensate for impaired hearing by transmitting vibrations to the middle ear. It is powered by a battery that is recharged inductively, via an external device. | C |
26 | Larynx prosthesis | A device used for replacement and restoration of the laryngeal function, or for maintenance of patency of the larynx. | C |
27 | Epistaxis balloon | Device intended to control internal nasal bleeding by exerting pressure against the sphenopalatine artery. | B |
28 | Eustachian tube balloon dilation system | The system is intended for use in dilating the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction. | B |
29 | Argon laser for otology, rhinology, and laryngology | Device is used for the purpose of coagulating and vaporizing soft and fibrous tissues, including osseous tissue while performing ENT surgical procedure. | C |
30 | Ear, nose, and throat microsurgical carbon dioxide laser | Device intended for the surgical excision of tissue from the ear, nose, and throat area while performing microsurgical procedures to exciselesions and tumors of the vocal cords and adjacent areas. | C |
31 | Esophagoscope (flexible or rigid) | Device intended to examine or treat esophageal malfunction symptoms, esophageal or mediastinal disease, or to remove foreign bodies from the esophagus. | B |
32 | Mediastinoscope and accessories | Device intended to examine or treat tissue in the area separating the lungs for diagnosis of tumors and lesions and to determine whether excision of certain organs or tissues is indicated. | B |
33 | Laryngostroboscope | A laryngostroboscope is a device that is intended to allow observation of glottic action during phonation. | B |
34 | Bone particle collector | A bone particle collector is a filtering device intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use. | A |
35 | Suction antichoke device | A suction antichoke device is a device intended tobe used in an emergency situation to remove, by the application of suction, foreign objects that obstruct a patient’s airway to prevent asphyxiation to the patient. | C |
36 | Tongs antichoke device | A tongs antichoke device is a device that is intended to be used in an emergency situation to grasp and remove foreign objects that obstruct a patient's airway to prevent asphyxiation of the patient. | C |
37 | Powered nasal irrigator | A powered nasal irrigator is an AC powered device intended to wash the nasal cavity by means of a pressure controlled pulsating stream of water. | B |
38 | Antistammering device | An antistammering device intended to minimize a user's involuntary hesitative or repetitive speech. It also prevent the user from hearing the sounds of his or her own voice | B |
39 | External upper esophageal sphincter compression device | An external upper esophageal sphinctercompression device is intended to apply external pressure on the cricoid cartilage for the purpose of reducing the symptoms of laryngopharyngeal reflux disease. | C |
40 | Wireless air conduction hearing aid | A wireless air conduction hearing aid is intended to compensate for impaired hearing thatincorporates wireless technology in itsprogramming or use. | B |
41 | Hearing aid calibrator and analysis system | A hearing aid calibrator and analysis system is an electronic reference device intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from hearing aid, master hearing aid, group hearing aid or group auditory trainer. | B |
42 | Tympanic membrane contact hearing aid | A tympanic membrane contact hearing aid is a prescription device that compensates for impaired hearing by vibrating the tympanic membrane through a transducer that is in direct contact with the tympanic membrane. | B |
43 | Master hearing aid | A master hearing aid is an electronic device intended to simulate a hearing aid during audiometric testing. | B |
44 | Active implantable bone conduction hearing system | The active implantable bone conduction hearing system is intended to compensate for conductive or mixed hearing losses by conveying amplified acoustic signals to the cochlea via mechanical vibrations on the skull bone. | C |
45 | Battery powered artificial larynx | A battery powered artificial larynx is an externally applied device intended for use in the absence of the larynx to produce sound. | B |
46 | Transcutaneous air conduction hearing aid system | A transcutaneous air conduction hearing aid system is a wearable sound amplifying device intended to compensate for impaired hearing without occluding the ear canal. | C |
47 | Gustometer | A gustometer is a battery powered device that consists of two electrodes that are intended to provide galvanic stimulus resulting in tastesensation. | B |
48 | ENT cupped forceps | A forceps with a spoon (dish) like configuration at the distal end, and is used to treat the ear, nose,and throat (ENT), and remove tissue from the body. | A |
49 | Tonsillectome | A manually operated surgical device used to dissect the tonsils. | A |
50 | ENT Nasal snare | A hand held manual surgical instrument intended to be inserted into the naris for the removal of tissue, typically polyps, tumours, and other abnormal tissue from the nasal cavity duringear/nose/throat (ENT) surgery | A |
51 | Soft tissue surgical forceps, alligator | A long, thin, hand held manual surgical instrument designed to facilitate grasping and manipulation ofsoft tissues/anatomical structures [typically duringear/nose/throat (ENT) surgery]. | A |
52 | Ear, nose, and throat electric or pneumatic surgical drill | An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat before the controlled incision or removal of bone in the ear, nose, and throat area. | B |
53 | Ear bowl | Constructed to fit the curvature of the head so that it will sit closely under the ear lobe and enable treatments of ear. | Class A (Self Notified) |
54 | Ear canal impression tray | Intended to hold and confine the impression material in opposition to the surfaces to be recorded, and to control the impression material while it sets to form the impression of the ear canal. | Class A (Self Notified) |
55 | Ear canal light | Intended to illuminate the ear canal. | Class A (Self Notified) |
56 | Ear wick | Intended to minimize bleeding during ear surgery. | Class A (Self Notified) |
57 | ENT chair, electric | Designed to support a patient in a seated position,electrically control position in a way to facilitate ear, nose, throat examination, treatment, and/or minor surgery. | Class A (Self Notified) |
58 | ENT chair, mechanical | Designed to support a patient in a seated position,mechanically control position in a way to facilitate ear, nose, throat examination, treatment, and/or minor surgery. | Class A (Self Notified) |
59 | ENT surgical microscope | Intended to magnify minute structures (e.g.,nerves, vessels) in the performance of ear, nose,and/or throat (ENT) surgery requiring high magnification and adjustable focusing. | Class A (Self Notified) |
60 | ENT transilluminator | Intended to illuminate sinus tissue during anear/nose/throat (ENT) procedure to render thetissue translucent for examination | Class A (Self Notified) |
61 | Nasal septum straightening forceps | Surgical instrument specifically designed to straighten the nasal septum through grasping and manipulation of the bone/cartilage of the septum during nasal reconstructive procedures. | Class A (Self Notified) |
62 | Otoscope, endoscopic | Intended to be used in otology mainly for observation, diagnosis, and treatment of the outer and/or middle ear. | Class A (Self Notified) |
63 | External nasal splint | An external nasal splint is a rigid or partially rigid device intended for use externally for immobilization of parts of the nose. | Class A (Self Notified) |
64 | Nasal dilator | A nasal dilator is a device intended to provide temporary relief from transient causes of breathing difficulties resulting from structural abnormalities and/or transient causes of nasal congestion associated with reduced nasal airflow. | Class A (Self Notified) |
65 | Acoustic chamber for audiometric testing | An acoustic chamber for audiometric testing is a room that is intended for use in conducting diagnostic hearing evaluations and that eliminates sound reflections and provides isolation from outside sounds. | Class A (Self Notified) |
66 | Tongue depressor | A surgical instrument used to move the tongue to facilitate examination of surrounding organs and tissue. | Class A (Self Notified) |
67 | Otoscope, direct | A portable, battery powered, hand held device(non endoscopic) primarily designed for examination of the outer ear canal and tympanic membrane (eardrum) by direct viewing through the ear opening. | Class A (Self Notified) |
Conclusion
Re classification of ENT devices medical devices in India according to the Medical Devices Rules 2017 ENT devices is an indication of the progress that has been made in terms of regulation by the Central Drugs Standard Control Organization (CDSCO). It is important that the manufacturers follow the CDSCO guidelines for ENT devices and CDSCO registration for ENT devices in India.
For medical device compliance and registration in India, contact Morulaa. For inquiries, send an email to admin@morulaa.com.
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