CDSCO risk classification
Software medical device classification
Every software device in CDSCO's classification register, with its risk class under the Medical Devices Rules, 2017 and its intended use. 1 are Class A non-sterile, non-measuring devices, which are exempt from licensing but must be registered.
- Devices
- 74
- Class A
- 4
- Class B
- 39
- Class C
- 31
- Class D
- 0
Software devices and their class
74 devices
AI-based Cardiovascular Risk/Probability Assessment Interpretive Software
Software
Class BAn artificial intelligence (AI)-based standalone software intended to analyze ECG images and highlight patterns that are suggestive of the presence of cardiac pathologies (e.g., cardiac arrhythmias, AV blocks, and other rhythm abnormalities, etc.) to aid trained healthcare professionals in further clinical diagnostic interpretation. The software does not provide automated diagnosis, treatment decisions, or therapeutic recommendations and is not intended to replace clinical judgment.
AI-Based Ophthalmic Image Analysis Software
Software
Class BAn artificial intelligence (AI)-based standalone software intended to preprocess and analyze retinal fundus images (either captured by an ophthalmic device or a smartphone camera) for assessing the probability/risk, and/or screen presence of ophthalmic conditions like age-related macular degeneration (AMD), glaucoma, etc., as an aid in professional diagnosis. This is intended for use by healthcare professionals (ophthalmologists, optometrists, general practitioners, etc.) and not intended for self-assessment. This is not intended for surgical planning or intraoperative use.This is not intended to replace clinical decision-making.
AI-Based Ophthalmic Self-Assessment Software
Software
Class BA web-based or mobile application based on artificial intelligence (AI) intended for use by laypersons in a non-clinical setting for self-assessment and screening of ophthalmic conditions, such as cataract, etc. using images taken from a smartphone camera. It may also be used for self-assessment of general vision-related parameters such as vision acuity, colour perception, contrast sensitivity, cataract screening etc. It is not intended to provide definitive diagnostic decisions or to replace professional clinical judgement. It is not intended for use in clinical settings, and it does not connect to any hardware medical device.
AI-based symptom analysis and clinical decision-support software
Software
Class BA cloud- or web-hosted artificial intelligence (AI)-based software intended for analysis of symptoms, patient medical data (including medical images), etc. as input by the users and providing differential diagnosis suggestions and their likelihood. This is intended for use by health practitioners across multiple systems of medicine, including Allopathy, Ayurveda, Homeopathy, and Unani, and by laypersons (through a cloud/web-based or mobile application). This is not intended for use in emergency situations. This is not intended to replace professional clinical judgement or to provide definitive diagnosis.
Analyzing software for hemodynamics or cardiac function
Software
Class BA medical device program that analyzes hemodynamics or cardiac function based on information obtained from diagnostic imaging systems, etc. and uses the results for diagnosis.
Anemia Drug-Dose Recommendation Software, professional-use
Software
Class BA standalone software application intended to provide physicians with optimal dosage recommendations for the erythropoiesis stimulating agent (ESA) and iron pharmacological treatments to maintain patient hemoglobin and ferritin levels within the targeted range in dialysis patients. This is not intended to substitute clinical judgement.
Angiographic Coronary Vascular Physiologic Simulation Software
Software
Class CAn angiographic coronary vascular physiologic simulation software device is intended to aid in the identification of functionally significant cardiovascular disease.
Ataxiagraph With Interpretive Software
Software
Class ADevice used to determine the extent of ataxia (failure of muscular coordination) by measuring the amount of swaying of the body when the patient is standing erect and with eyes closed and provides interpretation or clinical implication of the measurement.
Automated Radiological Image Processing Software
Software
Class BTo provide automated radiological image processing and artificial intelligence based analysis tools.
Automatic Event Detection Software For Full-Montage Electroencephalograph
Software
Class CAutomatically mark or identify electroencephalograph waveforms for spikes, electrographic seizures, seizure-like events in order to aid in identification of such events and help review and annotation of prolonged EEG traces All output subject to verification by qualified clinical user.
Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Software
Class CAutomatically mark electroencephalograph and polysomongraph signals in order to aid in identification of such events and annotation of prolonged PSG traces Automatically calculate simple measures obtained from recorded signals (e.g. Magnitude, time, frequency and simple statistical measures of marked events) All output subject to verification by qualified clinical user.
Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid
Software
Class CA traumatic brain injury eye movement assessment aid is a prescription device that uses a patients tracked eye movements to provide an interpretation of the functional condition of the patients brain.
Burn Resuscitation Decision Support Software
Software
Class CThe burn resuscitation decision support system (BRDSS) is intended for use in prediction of hourly fluid volume during initial 24 hours of burn resuscitation. It is intended for patients who have greater than 20% total body surface area burn.
Chairside dental CAD/CAM unit
Software
Class BIntended for computer-aided design (CAD) or computer-aided manufacturing (CAM) of dental restorations.
Chest X-Ray Computer Aided Detection
Software
Class BTo assist radiologists in the review of chest radiographic images and highlight potential nodules that the radiologist should review.
Child Development Assessment Application Software
Software
Class BA standalone software intended for use by healthcare professionals and/or untrained caregivers to obtain the measurement, tracking, forecasting, and optimization of developmental abilities in children aged 0–12 years, including those with developmental delays, autism spectrum and sensory-processing differences, motor and cognitive challenges, etc. The software is non-diagnostic and does not determine medical diseases.
Clinical Monitoring/Reporting Software
Software
Class CAn application software program intended for the continual collection and aggregation of a patient's medical data to promote communication between patient/caregiver and healthcare provider, to facilitate a patient's self-care (within the scope of the application), and/or to facilitate remote monitoring by a healthcare provider in clinical settings. It may be used in clinical or homecare settings. It may connect to compatible hardware medical devices and/or software to collect medical data, such as patient vitals. It may also be used for self-monitoring. It is not intended to replace professional clinical decisions or to provide a definitive treatment/diagnosis. Not for use in emergency situations.
Colon Computed Tomography System, Computer Aided Detection
Software
Class BTo assist radiologists in the review of multi-slice computed tomography (msct) exams of the colon and highlight potential polyps that the radiologist should review.
Computer- Assisted Diagnostic Software For Lesions Suspicious For Cancer
Software
Class CAssist clinical users in characterizing lesions identified on acquired medical images.
Computerized Behavioral Therapy Device For Psychiatric Disorders
Software
Class CThe device is intended to provide cognitive behavioral therapy to treat substance use disorder. The device is a software-based mobile app downloaded onto a smartphone.
Computerized Cognitive Assessment Aid For Concussion
Software
Class CFor use as an assessment aid in the management of concussion.
Continuous Glucose Monitor Retrospective Data Analysis Software
Software
Class AContinuous glucose monitor retrospective data analysis software is intended to analyze and correlate retrospective data from a continuous glucose monitoring device.
Continuous Glucose Monitor Secondary Display
Software
Class BThe purpose of the continuous glucose monitor secondary display is to notify another person, the follower, of the patients continuous glucose monitoring system sensor glucose information in real time.
Coronary Vascular Physiologic Simulation Software
Software
Class CA coronary vascular physiologic simulation software device is intended to aid in the identification of functionally significant cardiovascular disease by performing offline analysis of pre-existing imaging data to simulate blood flow in the coronary vasculature.
Dental Abutment Design Software For Dental Laboratory
Software
Class CThe software device is intended to aid in the restoration of chewing function by allowing a dental laboratory or dental clinician to design the patient-specific component of a dental abutment (i.e. abutment collar and abutment post) and CAM or create that component at a dental office or dental laboratory following the directions of the dental implant system.
Device, Fertility Diagnostic, Contraceptive, Software Application
Software
Class CDesigned to monitor and provide fertility information to prevent pregnancy (contraception).
Diabetic Retinopathy Detection Device
Software
Class CA retinal diagnostic software device is a software device that incorporates an adaptive algorithm to evaluate ophthalmic images for diagnostic screening to identify retinal diseases or conditions.
Diagnostic Software, K- Nearest Neighbor Algorithm, Autoimmune Disease
Software
Class BThe device is intended to suggest a systemic autoimmune disease association as an aid for differential diagnosis to be evaluated in conjunction with clinical findings and other laboratory tests.
Diagnostic supporting software for diabetes
Software
Class BA software that supports analysis and assessment of therapeutic effects of diabetes treatment by processeing information collected from a blood glucose meter, etc into the data related to changes or trends in blood glucose levels.
Dialysis Dose Calculation Application Software
Software
Class BA standalone software intended to calculate dialysis dose and display of renal therapy data. It is intended for use by trained healthcare professionals. It is not intended to control or influence the use of hemodialyzers and does not replace clinical judgement.
Electrocardiograph Software for home use.
Software
Class BDevice intended for home use which creates, analyzes, and displays electrocardiograph data, and can provide information for identifying cardiac arrhythmias.
Image Acquisition And/Or Optimization Guided By Artificial Intelligence
Software
Class BA radiological acquisition and/or optimization guidance system is a device that is intended to aid in the acquisition and/or optimization of images and/or diagnostic signals.
Index- Generating Electroencephalograph Software
Software
Class CAnalyze electrical activity of the brain by transformation of electroencephalograph signals into a dimensionless index number for use and interpretation by a qualified clinical user.
Information collating software for radiotherapy
Software
Class CA software that has function of collating the information such as irradiation parameter specified by a radiation planning software, and the condition that a radiotherapy equipment irradiates, on the occasion of the irradiation of X-ray in the radiotherapy.
Insulin Pump Secondary Display
Software
Class BThe purpose of the insulin pump secondary display is to notify another person of the patients insulin pump usage information in real time.
Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals
Software
Class CAn insulin pump therapy adjustment calculator for healthcare professionals is intended to recommend insulin pump therapy parameter adjustments (e.g., basal rate, insulin to carbohydrate ratios, insulin sensitivity factors) based on data from external devices, including continuous glucose monitors. The device is software with a graphical user interface.
Lung Computed Tomography System, Computer- Aided Detection
Software
Class BTo assist radiologists in the review of multi-slice computed tomography (MSCT) exams of the chest and highlight potential nodules that the radiologist should review.
Machine learning (ML)-based Asthma Screening Software
Software
Class BA machine learning (ML)-based, standalone software designed to capture and analyze respiratory sound data of laypersons (18 years and above) experiencing breathing-related symptoms (wheezing, breathlessness, cough, etc.) to assess the likelihood of having asthma in the future using respiratory sounds (exhalation) and other user-provided demographic details as input. This is not intended for diagnosis or to replace clinical advice.
Medical Image/Video Management Software
Software
Class ANon-sterile, non-measuringA software device intended to interface with compatible surgical camera/non-radiological image sources for acquisition, management, recording, viewing, documentation, etc. of still and video images of surgical procedures within the operating room environment. It may provide reporting and analytics related to operation theatre activities. It may also be referred to as an operating room (OR) integration software. It is NOT intended to control or operate any medical device or for primary output/analysis of radiological images/patient vitals.
Multiple Physiological Parameter Spot-check System Software
Software
Class BA software program intended to facilitate clinical management decisions by providing comprehensive health data visualization from vital sign measurements acquired from compatible vital signs spot check monitors. The software may monitor and perform statistical analysis, trend detection, anomaly identification, and population-level aggregation including individual vital trend, Time-series visualization etc. for vital parameters (i.e., heartrate, SpO2, systolic BP, diastolic BP, respiration rate, temperature). It is NOT intended for continuous monitoring in real-time or for intensive care. It is NOT intended to replace professional clinical judgement.
Multivariate Vital Signs Index
Software
Class BAutomated calculation of a summary index (or indices) based on several individual measured vital sign inputs. Collects measured parameter inputs and automates the calculation of a summary index based on those parameters.
Neonatal Resuscitation and Vital Monitoring Clinical Decision Support Software
Software
Class CA standalone software intended for real-time, protocol-aligned guidance during neonatal resuscitation at birth and continuous bedside monitoring of neonatal vital parameters in the special newborn care units with protocol-driven clinical alerts and management steps triggered by abnormal vital values, to support timely clinical decision-making. It can interface with patient monitors for vital monitoring. It does not control or influence the use of any hardware medical device.
Nephrology Information System Application Software
Software
Class BA standalone software intended to acquire, calculate, save, display, and transfer parameters of dialysis treatments. It is intended for use by trained healthcare professionals. It is not intended to control or influence the use of hemodialyzers.
Neuropsychiatric Interpretative Electroencephalograph Assessment Aid
Software
Class CIntended as an aid to provide an interpretation of the patients neuropsychiatric condition.
Normalizing Quantitative Electroencephalograph Software
Software
Class CPost-hoc statistical analysis of electroencephalograph signals with comparison to a normative database for interpretation by a qualified clinical user.
Ophthalmic Self-Assessment Software Application
Software
Class AA standalone web-based or mobile application software intended for use by laypersons as a screening tool for the self-assessment of general ocular symptoms associated with heavy screen usage and other environmental factors, including dry eye symptoms, eye fatigue, allergies, etc. It may utilize a clinically-relevant, standardized test (such as OSDI-6) and measure ocular parameters, such as blinking, etc., for providing likelihood of a condition. It is not intended to connect to any hardware medical device or analyze images taken from such a device. It is not intended for definitive diagnosis or to replace professional clinical judgement. It is not a screening/diagnostic aid for serious ocular pathologies.
Orthodontic Software
Software
Class CThe device is software that is to be used for the diagnosis and treatment planning of orthodontic patients and conditions.
Photoplethysmograph Analysis Software for home use
Software
Class BPhotoplethysmograph analysis software device for home analyzes of photoplethysmograph data and provides information for identifying irregular heart rhythms. This device is not intended to provide a clinical diagnosis.
Quantitative calculation software for IGC test
Software
Class BA software that performs quantitative calculation of blood flow in relation to a brightness time change based on information obtained from video images of indocyanine green angiography.
Radiological Computer Assisted Detection/Diagnosis Software For Fracture
Software
Class BA radiological computer assisted detection and diagnostic software for suspected fracture is an image processing device intended to aid in the detection, localization, and/or characterization of fracture on acquired medical images (e.g. radiography, MR, CT).
Software for active implanted device control
Software
Class CA software used to transmit one or more electrical operating characteristics noninvasively to the active base unit and change the characteristics.
Software for auditory evoked response stimulator
Software
Class BA software for medical device, which is designed to process data obtained from an auditory evoked response stimulator. The resultant data are provided for diagnosis, etc.
Software for dye dilution cardiac output calculator
Software
Class BA software, which is designed to process data obtained from a dye dilution cardiac output unit. The resultant data are provided for diagnosis, etc.
Software for ECG recorder with real-time analysis
Software
Class BA software, which is designed to process data obtained from an ECG recorder with real-time analysis. The resultant data are provided for diagnosis, etc.
Software for film-recorded digital radiography
Software
Class BA software, which is designed to process data obtained from a film-recorded digital radiography. The resultant data are provided for diagnosis, etc.
Software for gene variants analysis (for cancer genome profiling)
Software
Class CA software for gene variants analysis which is designed to perform cancer genome profiling based on information of gene variants obtained from body tissue samples.
Software for ophthalmic surgery treatment planning
Software
Class CA software for intended to aid ophthalmic surgical planning based on measurement of the eye prior to the surgery. It simulates surgical results.
Software for peritoneal dialysis treatment
Software
Class CA software that performs prescription simulation of peritoneal dialysis based on the results obtained from a peritoneal function test (PFT), a peritoneal equilibration test (PET) and a body composition analyzer. It supports preparation of a dialysis treatment plan.
Software for public thoracic and abdominal health screening diagnostic X- ray system
Software
Class BA software, which is designed to process data obtained from a thoracic and abdominal public health screening diagnostic X-ray system. The resultant data are provided for diagnosis, etc. This term may involve the recording media where the software are stored.
Software for pulmonary exercise stress monitoring system
Software
Class BA software, which is designed to process data obtained from a pulmonary exercise stress monitoring system.
Software for radiation planning
Software
Class CA software that calculates and displays the area to be treated with radiation and the internal dose distribution based on the results obtained with CT systems etc. and supports the radiotherapy planning.
Software for radiotherapy QAQC planning
Software
Class CA software that verifies the validity of the radiotherapy plan by recalculation of the dose and the MU value calculated with the radiotherapy planning system software and radiotherapy planning system.
Software for urodynamic measurement system
Software
Class BA software, which is designed to process data obtained from a urodynamic measurement system. The resultant data are provided for diagnosis, etc.
Software for using with mammography- combined diagnostic X- ray system
Software
Class BA software, which is designed to processes data obtained from a combined diagnostic mammography-radiography system.
Software for vestibular function caloric stimulator
Software
Class BA software, which is designed to process data obtained from a vestibular function caloric stimulator. The resultant data are provided for diagnosis, etc.
Software for visual evoked response stimulator
Software
Class BA software, which is designed to process data obtained from a visual evoked response stimulator. The resultant data are provided for diagnosis, etc.
Software For Visualization Of Vascular Anatomy And Intravascular Devices
Software
Class CVisualization and measurement of blood vessels and intravascular devices for preoperational planning.
Software, Similarity Score Algorithm, Tissue of Origin For Malignant Tumor Types
Software
Class CThis test is intended to measure the degree of similarity between the RNA expression pattern in a patients fresh-frozen tumor and the RNA expression patterns in a database of tumor samples for some common malignant tumor types that were diagnosed according to then current clinical and pathological practice.
Source Localization Software For Electroencephalograph or Magnetoencephalograph
Software
Class CCorrelation of electrical activity of the brain using various neuroimaging modalities for source-localization.
Supporting software for differential diagnosis with endoscopic imaging
Software
Class CA software, which is designed to process data obtained from an endoscopic image. The resultant data are provided for diagnostic, etc. It has functions to output numeric values and graphs based on quantitative data such as benign/malignant differentiation of lesion candidates, presenting candidates of diagnostic outcomes, and stage of disease progression.
Supporting software for root canal treatment
Software
Class BA software for medical device, which is used to support preparation of a treatment plan based on information collected from diagnostic imaging systems, etc. in the root canal treatment.
Surporting software for external fixators treatment plan
Software
Class BA software that analyzes information useful for bone fracture and for correction of bone deformities based on information collected from diagnostic X-ray systems, etc. or based on information entered in a therapeutic apparatus, and supports preparation of a treatment plan with external fixators.
Ventilator, software
Software
Class CA data program designed for use in, or together with, a ventilator allowing it to function according to the intended purpose. The software can be installed, or exchanged as an upgrade.
X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device
Software
Class BX-ray angiographic imaging based coronary vascular simulation software device is a device that provides an image analysis tool to assess blood flow in the coronary vascular system using X-ray angiographic imaging data. And yields simulation-based metrics for certain cardiology applications which aid clinical user.
Data from CDSCO's online system for medical devices, retrieved 2026-10-31.
Sources
- Risk Classification Approved Device Details, CDSCO online system for medical devices. Retrieved 31 October 2026.
- Merged existing medical devices risk classification, CDSCO public notice, 1 January 2025.
See the full source list and how the data is compiled on the main classification page. This is a reference aid, not legal or regulatory advice.
Other categories
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