CDSCO Registration for ENT Medical Devices

April 11, 2024

Registrationwala

If you are planning to open up an ENT Specialty Hospital with Operation Theatre (OT) and Out-patient Department (OPD) setup, you will have to keep all the ENT devices which are necessary for examining the ear, nose and throat of the patients. But before the ENT devices can be purchased by you, their manufacturers are required to get CDSCO registration for the ENT medical devices in India. Only then can such devices be used and purchased by you legally.

What are ENT Medical devices?

ENT means Ear, Nose and Throat. ENT medical devices are those devices which are meant for the ear, nose and throat. Some examples of ENT medical devices are audiometer, ear bowls and ENT surgical scope.

CDSCO is the regulatory body for the registration of various medical devices, including the ENT medical devices and comes with various responsibilities such like clinical trials, providing approval for devices, license renewal, inspection of medical devices, etc.

Medical devices for ENT requiring CDSCO registration

CDSCO has provided a list of all the medical devices for ENT which require registration. These medical devices have been classified in 4 categories, namely:

Class-A Low-risk devices
Class-B Low Moderate Risk
Class-C Moderate high-risk devices
Class-D High-risk devices

Medical Devices of Class A and B are considered to be less-risky & moderate medical devices. The application to manufacture such medical devices must be filed with the State Licensing Authority. Class C & Class D medical devices are considered to be high & very high-risk devices & their application must be filed with the Central Licensing Authority of India.

Here is a list of the ENT medical devices requiring CDSCO registration:

S.No.	Device Name	Intended Use	Risk Class
1	Adenotome	Surgical instrument for dissecting the adenoids.	A
2	Adenotome blade	Intended to mount on adenotome and perform dissection of adenoids.	B
3	Audiometer testing system	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	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 bowl	Constructed to fit the curvature of the head so that it will sit closely under the ear lobe and enable treatments of the ear.	A
11	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 ear canal’s impression.	A
12	Ear canal light	Intended for illuminating the ear canal.	A
13	Ear excavator	Designed for cutting, scraping, scooping and removing tissue at the time of a surgical procedure for the ear.	A
14	Ear prosthesis	Intended to reconstruct the external ear by replacing damaged or missing tissue.	C
15	Ear wick	Intended to minimize bleeding during ear surgery.	A
16	Electroglottograph	Intended for recording the changes in electrical potential or impedance, resulting from movement of the vocal cords during respiration and phonation.	B
17	Endaural curette	Designed for scraping within the ear canal and for procedures during middle ear surgery.	A
18	ENT chair, electric	Designed to support a patient in a seated position, electrically controlled position in a way to facilitate ENT examination/ treatment/minor surgery.	A
19	ENT chair, mechanical	Designed to support a patient in a seated position, mechanically control position in a way to facilitate ENT examination/ treatment/minor surgery.	A
20	ENT shaver system	Intended to resect/debride soft and osseous (bone) tissue in the nasal cavity or ear region ENT or plastic surgery procedures.	B
21	ENT surgical microscope	Intended to magnify minute structures in the performance of ENT surgery	A
22	ENT transilluminator	Intended to illuminate sinus tissue during an ENT procedure to render the tissue translucent for examination	A
23	Evoked-potential audiometer	Designed to evaluate the activity of the auditory pathway of the brain in response to an acoustic signal in patients.	B
24	Flexible fiberoptic nasopharyngo laryngoscope	Intended for the visual examination and treatment of the nasal passages.	B
25	Flexible fiberoptic nasopharyngoscope	Intended for the visual examination and treatment of nasopharynx (the upper part of the throat behind the nose).	B
26	Flexible fiberoptic rhinoscope	Intended for the visual examination and treatment of nasal cavity.	B
27	Flexible fiberoptic sinoscope	Intended for the visual examination and treatment of the paranasal sinuses during an ear/nose/throat (ENT) intervention.	B
28	Flexible video antroscope	Intended for the visual examination and treatment of a cavity, particularly the pathological changes in the area of the maxillary sinus.	B
29	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
30	Nasal septum straightening forceps	Designed to straighten the nasal septum through grasping and manipulation of the bone/cartilage of the septum during nasal reconstructive procedures.	A
31	Otoscope, endoscopic	Intended to be used in otology mainly for observation, diagnosis, and treatment of the outer and/or middle ear.	A
32	Tonsil knife	Intended for the removal of the tonsils during a surgical intervention.	A
33	Tracheal bistoury	Designed for opening abscesses or slitting up sinuses and/or fistulas in the trachea.	A
34	Middle ear mold	A device intended to be implanted to reconstruct the middle ear cavity during repair of the tympanic membrane.	C
35	Fully-implantable middle ear implant system	Intended to compensate for impaired hearing by transmitting vibrations to the middle ear.	C
36	Larynx prosthesis	Used for replacement and restoration of the laryngeal function, or for maintenance of patency of the larynx.	C
37	Epistaxis balloon	Intended to control internal nasal bleeding by exerting pressure against the sphenopalatine artery.	B
38	Eustachian tube balloon dilation system	Intended for dilating the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction.	B
39	Argon laser for otology, rhinology, and laryngology	Intended for coagulating and vaporizing soft and fibrous tissues while performing ENT surgical procedure.	C
40	Ear, nose, and throat microsurgical carbon dioxide laser	Used for the surgical excision of tissue from the ear, nose, and throat area while performing microsurgical procedures to excise lesions and tumors of the vocal cords and adjacent areas.	C
41	Esophagoscope (flexible or rigid)	Intended to examine or treat esophageal malfunction symptoms, esophageal or mediastinal disease, or to remove foreign bodies from the esophagus.	B
42	Mediastinoscope and accessories	Intended to examine/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
43	Laryngostroboscope	Intended to allow observation of glottic action during phonation.	B
44	Bone particle collector	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
45	Suction antichoke device	A device intended to be 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
46	Tongs antichoke device	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
47	Powered nasal irrigator	A device intended to wash the nasal cavity by means of a pressure-controlled pulsating stream of water.	B
48	External nasal splint	A device intended for use externally for immobilization of parts of the nose.	A
49	Anti-stammering 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
50	External upper esophageal sphincter compression device	Intended to apply external pressure on the cricoid cartilage for the purpose of reducing the symptoms of laryngopharyngeal reflux disease.	C
51	Wireless air-conduction hearing aid	Intended to compensate for impaired hearing that incorporates wireless technology in its programming or use.	B
52	Hearing aid calibrator and analysis system	Intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid, master hearing aid, group hearing aid or group auditory trainer.	B
53	Tympanic membrane contact hearing aid	A device that compensates for impaired hearing by vibrating the tympanic membrane through a transducer that is in direct contact with the tympanic membrane.	B
54	Master hearing aid	A master hearing aid is an electronic device intended to simulate a hearing aid during audiometric testing.	B
55	Active implantable bone conduction hearing system	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
56	Battery-powered artificial larynx	A device intended for use in the absence of the larynx to produce sound.	B
57	Nasal dilator	A device intended to provide temporary relief from transient causes of breathing difficulties.	A
58	Transcutaneous air conduction hearing aid system	A sound-amplifying device intended to compensate for impaired hearing without occluding the ear canal.	C
59	Acoustic chamber for audiometric testing	A room that is intended for use in conducting diagnostic hearing evaluations and that eliminates sound reflections and provides isolation from outside sounds.	A
60	Gustometer	A device that consists of two electrodes that are intended to provide galvanic stimulus resulting in taste sensation.	B
61	ENT cupped forceps	A forcep with a spoon-(dish) like configuration at the distal end used to treat the ear, nose, and throat (ENT), and remove tissue from the body.	A
62	Tongue depressor	Used to move the tongue to facilitate examination of surrounding organs and tissue.	A
63	Tonsillectome	A manually operated surgical device used to dissect the tonsils.	A
64	ENT Nasal snare	Intended to be inserted into the naris for the removal of tissue, typically polyps, tumors, and other abnormal tissue from the nasal cavity.	A
65	Otoscope, direct	A device (non-endoscopic) primarily designed for examination of the outer ear canal and tympanic membrane (eardrum) by direct viewing through the ear opening.	A
66	Soft-tissue surgical forceps, alligator	A surgical instrument designed to facilitate grasping and manipulation of soft-tissues/anatomical structures.	A
67	Ear, nose, and throat electric or pneumatic surgical drill	A rotating drilling device intended to drive various accessories, such as an ear, nose, and throat bur for the controlled incision or removal of bone in the ear, nose, and throat area.	B

Source

Conclusion

CDSCO registration is necessary for the manufacturers of ENT medical devices in India. Our team leaders at Registrationwala come with years of experience when it comes to assisting our clients in obtaining CDSCO Registration.

CDSCO Registration for ENT Medical Devices