Introduction:
This article deals with the latest rules of Respiratory as 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 Respiratory and Medical Device in India. All Respiratory 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 51.
Table: Respiratory as Medical Device India
| S.No | Medical Device Name | Intended Use | Risk Based Classification |
| 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 | Bulk oxygen concentration system | An assembly of devices designed to concentrate medical grade oxygen (O2) from ambient air and then deliver the concentrated O2, with purity of up to 93%- 99.5%, to the hospital medical gas supply system for therapeutic use on patients in Hospital. | A |
| 5 | 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 |
| 6 | Cerebral oximeter | A device used as an adjunct monitor for the regional haemoglobin oxygen saturation of blood in the brain of a patient. | B |
| 7 | 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 |
| 8 | 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 |
| 9 | Cold-air diagnostic inhalation system | An assembly of devices intended to be used in the assessment of a pateint suffering from asthma. | B |
| 10 | 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 |
| 11 | 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 |
| 12 | Dry powder inhaler | A hand-held device designed to administer powdered medicine through the mouth and into the bronchial airways. | A |
| 13 | 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 |
| 14 | 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 |
| 15 | 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 |
| 16 | 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 |
| 17 | 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 |
| 18 | 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 |
| 19 | 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 |
| 20 | 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 |
| 21 | Hyperbaric chamber | The intended use of the Hyperbaric Chamber is to administer 100% oxygen at pressure greater than ambient. | C |
| 22 | 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 |
| 23 | 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 |
| 24 | 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 |
| 25 | Infant apnoea monitor | A device that is used to register the respiratory rate of an infant and which gives an alarm signal (e.g., audible/visual) when the pre-set limits are exceeded caused by an extended interruption or cessation (apnoea) of the infants breathing pattern; a condition known as sudden infant death syndrome (SIDS). | B |
| 26 | 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 |
| 27 | Nitrogen monoxide analyser | A device intended to measure nitric oxide (NO), in exhaled air to facilitate diagnosis and management of asthma. | B |
| 28 | 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 |
| 29 | 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 |
| 30 | Respiratory apnoea monitoring system | An assembly of devices designed to detect the cessation of breathing (apnoea) in patient who are at risk of respiratory failure to alert a parent or attendant of the life-threatening episode(s). | B |
| 31 | 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 |
| 32 | 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 |
| 33 | 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 |
| 34 | 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 |
| 35 | 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 |
| 36 | Thoracic electrical impedance segmentography system | An assembly of devices designed to perform thoracic bio-impedance measurements to continuously record the distribution of air across 4 quadrants of the lungs, commonly of a neonatal/infant patient to detect changes in lung ventilation at a regional level, to assist in the diagnosis of lung conditions. | B |
| 37 | 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 |
| 38 | 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 |
| 39 | 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 |
| 40 | Tracheostoma protective filter | A device designed as a filter for protecting a stomal opening in the windpipe against harmful external influences. | A |
| 41 | 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 |
| 42 | 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 |
| 43 | 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 |
| 44 | Valsalva manoeuvre mouthpiece | A device intended to be inserted into a patient’s mouth to facilitate performance of the Valsalva manoeuvre. | A |
| 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 |
| 46 | Whole-body plethysmograph | A graphic recorder designed for determining and registering airway resistance and thoracic gas volume to assess pulmonary function. | B |
| 47 | Diagnostic Spirometer | A device designed to measure several or all respiratory- gas volume and flow parameters needed to evaluate basic pulmonary function. | B |
| 48 | 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 |
| 49 | Oxygen Concentrator | A device designed to concentrate oxygen (O2) from ambient air and deliver the concentrated O2 to patient. | B |
| 50 | Pulmonary function analysis system | A device used to measure the function of the respiratory system in adults and compliant children. | B |
| 51 | 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 |
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 Respiratory as a Medical Device India. In order to comply with the 30th September of Respiratory 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..