CDSCO Licensing Requirement for ENT Medical Devices in India
CDSCO notified 67 ENT (Ear-Nose-Throat) devices on August 6, 2022. Manufacturers of these devices must obtain a mandatory medical device license from Licensing Authorities to continue manufacturing in India.
These devices are classified into 3 risk-based categories Class A, Class B, and Class C. To manufacture ENT devices in India, you must obtain a license from CDSCO. The specific licensing requirements can vary depending on the class and type of ENT devices you intend to manufacture.
Licensing Authorities for ENT Medical Devices in India
The Central Drugs Standard Control Organization (CDSCO) is the licensing authority for medical devices of Class C and Class D in India. Class C and Class D devices are those that pose a higher risk to patients. The State Licensing Authority is the licensing authority for medical devices of Class A and Class B in India. Class A and Class B devices are those that pose a lower risk to patients.
List of Class A ENT Medical Devices
- Adenotome: A surgical instrument used to remove adenoids.
- Audiometer testing system: A device that is used to calibrate audiometers.
- Ear canal impression tray: A device that is used to hold and confine impression material in the ear canal.
- Ear canal light: A device that is used to illuminate the ear canal.
- Ear excavator: A device that is used to cut, scrape, scoop, and remove tissue from the ear canal.
- Ear wick: A device that is used to minimize bleeding during ear surgery.
- Endaural curette: A device that is used to scrape within the ear canal (e.g., removing wax).
- ENT chair: A chair that is used to support a patient during ear, nose, and throat examination, treatment, and/or minor surgery.
- ENT surgical microscope: A microscope that is used to magnify minute structures in the ear, nose, and throat during surgery.
- ENT transilluminator: A device that is used to illuminate sinus tissue during an ear/nose/throat procedure.
- 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.
- Otoscope, endoscopic: A device that is used to examine the outer and/or middle ear.
- Tonsil knife: A knife that is used to remove tonsils during a surgical intervention.
- Tracheal bistoury: A knife that is used to open abscesses or slit up sinuses and/or fistulas in the trachea.
- Bone particle collector: A device that is used to collect bone particles during otologic surgery.
- External nasal splint: A splint that is used to immobilize parts of the nose.
- Nasal dilator: A device that is used to provide temporary relief from breathing difficulties.
- Acoustic chamber for audiometric testing: A room that is used to conduct diagnostic hearing evaluations.
- ENT cupped forceps: A forceps that is used to treat the ear, nose, and throat and remove tissue from the body.
- Tongue depressor: A device that is used to move the tongue to facilitate examination of surrounding organs and tissue.
- Tonsillectome: A surgical device that is used to dissect tonsils.
- ENT Nasal snare: A hand-held surgical instrument that is inserted into the naris for the removal of tissue, typically polyps, tumors, and other abnormal tissue from the nasal cavity during ear/nose/throat surgery.
- Otoscope, direct: A portable, battery-powered, hand-held device that is used to examine the outer ear canal and tympanic membrane (eardrum) by direct viewing through the ear opening.
- Soft-tissue surgical forceps, alligator: A long, thin, hand-held surgical instrument that is used to facilitate grasping and manipulation of soft-tissues/anatomical structures during ear/nose/throat surgery.
List of Class B ENT Medical Devices
- Adenotome blade: A surgical blade used to remove adenoids.
- Audiometer: A device that produces sounds to test hearing.
- Evoked response auditory stimulator: A device that produces a sound stimulus to measure the electrical activity of the brain in response to sound.
- Behind-the-ear air-conduction hearing aid: A hearing aid that is worn behind the ear and amplifies sound waves that travel through the air.
- Behind-the-ear air-conduction tinnitus masker: A device that produces noise to mask the sound of tinnitus.
- Electroglottograph: A device that measures the electrical activity of the vocal cords during speech.
- ENT shaver system: A surgical system that uses a high-speed rotating blade to remove tissue in the ear, nose, and throat.
- Evoked-potential audiometer: A device that measures the electrical activity of the brain in response to sound.
- Flexible fibreoptic nasopharyngo laryngoscope: A flexible endoscope that is inserted through the nose to view the larynx and vocal cords.
- Flexible fibreoptic nasopharyngoscope: A flexible endoscope that is inserted through the nose to view the nasopharynx.
- Flexible fibreoptic rhinoscope: A flexible endoscope that is inserted through the nose to view the nasal cavity.
- Flexible fibreoptic sinoscope: A flexible endoscope that is inserted through the nose to view the paranasal sinuses.
- Flexible video antroscope: A flexible endoscope that is inserted through the nose to view the maxillary sinus.
- Impedance audiometer: A device that measures the mobility of the eardrum and middle ear bones.
- Epistaxis balloon: A balloon that is inserted into the nose to stop bleeding.
- Eustachian tube balloon dilation system: A system that uses a balloon to dilate the Eustachian tube, which connects the middle ear to the back of the throat.
- Esophagoscope (flexible or rigid): A flexible or rigid tube that is inserted through the mouth to view the esophagus.
- Mediastinoscope and accessories: A set of instruments that are used to view the mediastinum, the area between the lungs.
- Laryngostroboscope: A device that produces a strobe light that is used to visualize the vocal cords during speech.
- Powered nasal irrigator: A device that uses a stream of water to clean the nasal passages.
- Antistammering device: A device that is worn on the tongue or cheek to help people who stutter.
- Wireless air-conduction hearing aid: A hearing aid that uses wireless technology to transmit sound to the ear.
- Hearing aid calibrator and analysis system: A device that is used to calibrate and test hearing aids.
- Tympanic membrane contact hearing aid: A hearing aid that is placed directly on the tympanic membrane, the thin membrane that separates the ear canal from the middle ear.
- Master hearing aid: A hearing aid that is used to calibrate other hearing aids.
- Battery-powered artificial larynx: A device that is used to produce sound in the absence of the larynx.
- Gustometer: A device that is used to measure taste sensation.
- Ear, nose, and throat electric or pneumatic surgical drill: A drilling device that is used to remove bone in the ear, nose, and throat area.
List of Class C ENT Medical Devices
- Behind-the-ear bone-conduction tinnitus masker: A device that is worn behind the ear and delivers ultrasonic broadband noise and/or sweep-frequency stimuli to mask tinnitus.
- Cochlear implant assessment system: A device that is used to test the implantable portion of a cochlear implant (CI) system.
- Ear prosthesis: A device that is implanted to reconstruct the external ear by replacing damaged or missing tissue.
- Middle ear mold: A preformed device that is implanted to reconstruct the middle ear cavity during repair of the tympanic membrane.
- Fully-implantable middle ear implant system: An implanted system that compensates for impaired hearing by transmitting vibrations to the middle ear. It is powered by a battery that is recharged inductively.
- Larynx prosthesis: A device that is used to replace or restore the function of the larynx.
- Argon laser for otology, rhinology, and laryngology: A laser that is used to coagulate and vaporize soft and fibrous tissues, including osseous tissue, during ENT surgical procedures.
- Ear, nose, and throat microsurgical carbon dioxide laser: A laser that is used to excise tissue from the ear, nose, and throat area during microsurgical procedures.
- Suction antichoke device: A device that is used to remove foreign objects that obstruct a patient’s airway by suction.
- Tongs antichoke device: A device that is used to grasp and remove foreign objects that obstruct a patient’s airway.
- External upper esophageal sphincter compression device: A device that is applied to the cricoid cartilage to reduce the symptoms of laryngopharyngeal reflux disease.
- Active implantable bone conduction hearing system: A system that is implanted to compensate for conductive or mixed hearing losses by conveying amplified acoustic signals to the cochlea via mechanical vibrations on the skull bone.
- Transcutaneous air conduction hearing aid system: A wearable system that amplifies sound and delivers it to the ear without occluding the ear canal.
Are You Looking for a License to Manufacture ENT Medical Devices in India?
Contact MedDev Experts today! We have a team of experienced professionals who can help you navigate the complex regulatory process and get your license approved.
ENT Medical Device Licensing Requirements:
- To manufacture Class A and Class B ENT Medical Devices in India, you must obtain the MD 5 License from the State Licensing Authority.
- To manufacture Class C ENT Medical Devices in India, you must obtain the MD 9 License from the Central Drugs Standard Control Organization (CDSCO).
- To import ENT Medical Devices into India, you must obtain the MD 15 Import License from the CDSCO.
Requirements for Manufacturing, Importing, and Distributing ENT Medical Devices in India
- Class A and Class B devices: MD 5 License from the State Licensing Authority
- Class C devices: MD 9 License from the CDSCO
- Import: MD 15 Import License from the CDSCO.
Validity of ENT Medical Device Licenses in India
ENT medical device licenses are valid indefinitely, as long as the retention fee is paid every 5 years.
How to Apply Online for ENT Medical Device Manufacturing or Import Licenses in India
- Step 1: Enroll your organization on CDSCO’s SUGAM Portal.
- Step 2: Fill in the respective applications and submit them through CDSCO’s online SUGAM Portal.
- Step 3: Upload the necessary documents and make the required payment.
- Step 4: Your application will be scrutinized by the CDSCO Team. If it meets the requirements, it will proceed to a quality management system compliance audit.
- Step 5: The Team will conduct an audit at your manufacturing premises. If any Non-Conformance (NC) is identified, you will be required to submit an NC closure report.
- Step 6: Once all the conditions are met, CDSCO will grant the license.
Deadline for Obtaining ENT Medical Device Licenses in India
The deadline for obtaining ENT medical device licenses in India is October 1, 2022 for Class A and Class B devices, and September 30, 2023 for Class C and Class D devices.
List of Documents for Obtaining an ENT Medical Device Manufacturing License
- Organization identity proof: This could be the Memorandum of Association, List of Directors or Partners, UDYAM Aadhar, or PAN card.
- Sale Deed / Rent Deed of the Premises: This document proves that you have legal ownership of the premises where you will be manufacturing the medical devices.
- Plant or Site Master File: This file contains information about the layout of your manufacturing facility, as well as the equipment and processes you will be using.
- Building Layout with Dimension: This is a detailed drawing of your manufacturing facility, showing the dimensions of each room and the location of all equipment.
- ISO 13485 Certificate and Previous Audit Reports: This certificate shows that your manufacturing facility meets international standards for quality management systems.
- Competent Technical Staff for Manufacturing and Testing of Devices: You must have a team of qualified and experienced staff who can manufacture and test your medical devices.
- Device Master File: This file contains detailed information about each medical device you will be manufacturing, including its design, manufacturing process, and testing procedures.
- Test License, if any: If you need a license to test your medical devices, you must obtain it before you can start manufacturing them.
- Compliance with the environmental requirements: You must comply with all applicable environmental regulations, such as those related to cleanrooms for manufacturing the devices.
- Certificate of Analysis of 3 Consecutive Batches: This certificate shows that the first 3 batches of medical devices you manufactured meet the required quality standards.
