Introduction: Respiratory Equipment Classification in India
Respiratory medical devices play an important role in diagnosis, monitoring, and treatment of respiratory conditions. Under the Medical Device Rules 2017 in India, respiratory equipment is classified based on risk levels in accordance with medical device registration in India.
The Central Drugs Standard Control Organization (CDSCO) continues to update its CDSCO medical device classification in India by periodically updating classifications in line with global standards. The latest update reclassifies certain respiratory devices, simplifying the regulatory pathway for manufacturers while ensuring medical device compliance in India.
India is Updating Existing Risk-Based Classifications for Respiratory Equipment |
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As per the latest notification MED-16014(12)/1/2024-eOffice released on January 6th, 2025, 9 respiratory devices have been reclassified from Class A to Class A (Self Notified). This change simplifies the compliance process for low-risk devices and aligns with the Updated CDSCO medical device rules in India framework. To read the official CDSCO notification and view the complete list of updated classifications across multiple categories, click here. |
Table: CDSCO Respiratory Equipments Classification in India
The table below provides the updated classification for respiratory equipment in India under the CDSCO medical device classification in India. The newly reclassified devices from Class A to Class A (Self Notified) have been highlighted as dark grey for easy identification.
| S.No | Device name as per Medical Device Rules 2017 in India | Intended Use | Risk Class |
| 1 | Activated-oxygen generator | It is a device that makes activated oxygen (singlet oxygen) which is mixed with room air and produces activated water as a by-product. | B |
| 2 | Argon gas analyser | An instrument intended to measure the concentration (partial pressure) of argon (Ar) in a gas mixture sample to aid in determining a patient’s ventilatory status. | B |
| 3 | Artificial airway tube cuff pressure monitor | A device intended to intermittently or continuously measure the internal pressure in the cuff of an endotracheal (ET)/endobronchial/tracheostomy tube when this has been situated into the tracheal passage. | B |
| 4 | Chest-oscillation airway secretion-clearing system | Devices designed to provide high frequency chest wall oscillation (HFCWO) for external chest wall manipulation intended to loosen excessive airway secretions to promote airway clearance and improve bronchial drainage for patients with respiratory disease. | B |
| 5 | Chest-percussion airway secretion-clearing system | Devices designed to provide external mechanical percussion (rapid tapping) to the chest wall of a patient to loosen excessive airway secretions to promote airway clearance and improve bronchial drainage for patients with respiratory disease. | B |
| 6 | Cold-air diagnostic inhalation system | An assembly of devices intended to be used in the assessment of a patient suffering from asthma. | B |
| 7 | Cough long-term ambulatory recording system | An assembly of devices intended for long-term detection and recording of the number of times a patient coughs during daily activities or sleep. | A |
| 8 | Cricothyrotome | A hand-held manual surgical instrument intended to be used to perform a cricothyrotomy providing airway access within seconds for immediate ventilation of the patient and necessary suction procedures. | B |
| 9 | Electroacoustical airway secretion-clearing system | An assembly of devices designed to provide externally applied vibrations to the chest wall of a patient via an electroacoustical transducer (the applicator) to loosen excessive airway secretions to promote airway clearance and improve bronchial drainage for patients with respiratory disease. | B |
| 10 | Exhaled-gas oesophageal intubation detector | A device designed to verify proper endotracheal (ET) tube placement by detecting/assessing escaping levels of exhaled carbon dioxide (CO2) during airway management disclosing potential incorrect intubation. | A |
| 11 | Foetal pulse oximeter | A photoelectric device designed for the monitoring of intrapartum foetal oxygen saturation (FSpO2) in the presence of a non-reassuring foetal heart rate (FHR) pattern during labour. | B |
| 12 | Gas pipeline/supply system air compressor | A device designed to create compressed medical grade air, and supply it to a hospital or institution’s gas pipeline/supply system for patient use. | B |
| 13 | Heated respiratory humidifier | A device designed to heat and humidify air/oxygen inspired by a patient to help maintain the mucous membranes of the respiratory tract typically during periods of prolonged respiratory support/therapy. | B |
| 14 | Home-use sleep apnoea recording system | A device intended to continuously measure and record patient physiological parameters during sleep in the home, to facilitate the diagnosis of sleep apnoea. | B |
| 15 | Hyperbaric chamber | The intended use of the Hyperbaric Chamber is to administer 100% oxygen at pressure greater than ambient. | C |
| 16 | Hypopnea sensor/alarm | An electronic device intended to be used to indicate patient hypopnea by monitoring the movement of the thorax and abdomen with each breath and provides a signal, according to predetermined settings. | B |
| 17 | Impedance pneumography recording/analysis system | An assembly of electronic devices intended for continuous recording of a patient’s pulmonary function parameters using impedance pneumography (IP). | B |
| 18 | Implantable sleep apnoea treatment system | An assembly of devices intended for home management of obstructive sleep apnoea (OSA) using an implanted stimulator to provide electrical stimulation to the hypoglossal nerve. | C |
| 19 | Manual chest percussor | A hand-held device designed to facilitate manual percussion (rapid tapping) to provide external vibrations to the chest wall of a patient to loosen excessive airway secretions to promote airway clearance and improve bronchial drainage for patients with respiratory disease. | B |
| 20 | Nitrogen monoxide analyser | A device intended to measure nitric oxide (NO), in exhaled air to facilitate diagnosis and management of asthma. | B |
| 21 | Nitrous oxide analyser | An instrument used to measure the concentration of nitrous oxide (N2O) in a sample of a gas mixture taken from an enclosed environment such as a healthcare facility, a compressed medical air or gas system, and/or devices used for anaesthesia administration or respiratory therapy. | B |
| 22 | Pulse oximetry telemetric monitoring system | An assembly of devices designed to continuously measure and wirelessly transmit haemoglobin oxygen saturation (SpO2) signals from a patient to a receiving location for viewing. | B |
| 23 | Stress test treadmill | A device used as a component of a stress test system that permits the evaluation of a patient’s physiologic response to physical stress. | A |
| 24 | Therapeutic air ionizer | A device that produces small, biologically-active, negatively-charged ions of oxygen (O2), pulsed at various selected frequencies, that are emitted into the ambient air and absorbed into the bloodstream via the lungs to potentially produce a therapeutic effect. | A |
| 25 | Therapeutic positive pressure breathing ventilator | A device used for therapeutic rehabilitation of patients with chronic respiratory diseases, and for the distribution of aerosolized pharmacological agents to the patient’s airways and lungs. | C |
| 26 | Thoracic bioconductance measurement system | An assembly of devices designed to measure and store bioconductance measurements, analyse the stored data and provide information that can aid a clinician in their evaluation of lesions suspicious of lung cancer. | B |
| 27 | Thoracic electrical impedance tomography system | An assembly of devices designed to perform continuous bio-impedance measurements throughout a cross-section of the thorax, to provide real-time feedback of lung function of a ventilated patient. | C |
| 28 | Thoracic suction pump | A device intended to generate negative pressure specifically for aspiration, to remove fluids, secretions and air to allow for the normal expansion/function of the lungs and/or mediastinum. | B |
| 29 | Tongue-adjustment sleep apnoea treatment system | An assembly of devices intended for home management of obstructive sleep apnoea (OSA) by monitoring breathing parameters during sleep to detect the onset of an apnoea event and reducing pharyngeal obstruction by the tongue. | B |
| 30 | Tracheostoma protective filter | A device designed as a filter for protecting a stromal opening in the windpipe against harmful external influences. | A |
| 31 | Transcutaneous blood gas monitoring system | An assembly of devices designed for the continuous and transcutaneous measurement of a patient’s blood gas parameters detected through the jugular vein (SjvO2). | B |
| 32 | Whole-body plethysmograph | A graphic recorder designed for determining and registering airway resistance and thoracic gas volume to assess pulmonary function. | B |
| 33 | Diagnostic Spirometer | A device designed to measure several or all respiratory- gas volume and flow parameters needed to evaluate basic pulmonary function. | B |
| 34 | Monitoring Spirometer | A device designed to measure continuously a patient’s tidal volume or minute volume for the evaluation of the patient’s ventilatory status. | B |
| 35 | Oxygen Concentrator | A device designed to concentrate oxygen (O2) from ambient air and deliver the concentrated O2 to patients. | B |
| 36 | Public respirator (2 ply, 3 ply face mask) | A filtering mask designed to be placed over the nose and mouth of a member of the general public to permit normal breathing while protecting the wearer from exposure to pathogenic biological airborne particulates during a public health medical emergency. | A |
| 37 | Cardiopulmonary resuscitation mask | A device that intended to be placed over a patient’s mouth to administer “mouth-to-mask” exhaled air from the user to the patient during cardiopulmonary resuscitation (CPR). | A (Self Notified) |
| 38 | Dry powder inhaler | A hand-held device designed to administer powdered medicine through the mouth and into the bronchial airways. | A (Self Notified) |
| 39 | Dry salt therapy device | A hand-held inhaler prefilled with salt crystals and used to provide an inhalation of salt particles through the mouth and into the bronchial airways to induce natural self-cleansing mechanisms that flush away the impurities from the surface of cells and mechanically clean the airways. | A (Self Notified) |
| 40 | Endotracheal tube introducer | A device designed to help with the insertion of an endotracheal (ET) tube into the airways of a patient during intubation | A (Self Notified) |
| 41 | Steam inhaler | An electrically-powered, hand-held device designed for the inhalation of steam for the relief of the symptoms (congestion and pressure) associated with upper respiratory disorders. | A (Self Notified) |
| 42 | Tracheostoma protector | A patient-worn device in the form of a patch, collar, or cloth designed to be fastened around the neck to protect a tracheostoma orifice against harmful external influences. It is not intended to be used as a shower shield. | A (Self Notified) |
| 43 | Tracheostomy tube lubricant | A substance made of oil designed to be applied by healthcare staff or a patient to the outer surface of a tracheostomy tube inner cannula to facilitate its easy sliding into the outer cannula. | A (Self Notified) |
| 44 | Valsalva manoeuvre mouthpiece | A device intended to be inserted into a patient’s mouth to facilitate performance of the Valsalva manoeuvre. | A (Self Notified) |
| 45 | Video intubation laryngoscope handle/monitor | A component of a bladed video intubation laryngoscope intended to enable the positioning of the blade into the oral cavity to manipulate the tongue, preventing it from obstructing the oropharynx and enabling a clear view of the trachea for the insertion of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation. | A (Self Notified) |
Conclusion: Medical Device Compliance in India for Respiratory Equipment
This article is based on notifications 29/Misc./03/2020-DC (197) and MED-16014(12)/1/2024-eoffice, outlining the regulation of medical devices. The CDSCO medical device classification in India helps manufacturers stay compliant as per the latest regulations in India. Manufacturers must adhere to the Medical Device Rules 2017 in India. For expert guidance on medical device registration in India, contact Morulaa. Our in-house consultancy team offers end-to-end solutions to navigate these regulatory updates efficiently, email us at admin@morulaa.com or visit our website for the latest updates