CDSCO notified 66 radiology medical devices on 13 September 2021 under the Medical Devices Rules, 2017. These devices span all four risk classes — Class A (low risk), Class B (low-to-moderate risk), Class C (moderate-to-high risk), and Class D (high risk) — and include nuclear medicine imaging systems, ultrasound devices, X-ray systems, MRI machines, foetal monitors, and radiological AI/CAD software. Class A and B radiology devices require an MD5 manufacturing license from the State Licensing Authority (fee: Rs. 5,000 + Rs. 500/device). Class C and D radiology devices require an MD9 manufacturing license from CDSCO Headquarters (fee: Rs. 50,000 + Rs. 1,000/device). Importers of any class require an MD15 import license from CDSCO. Applications are submitted through the CDSCO SUGAM portal (cdscoonline.gov.in).
Radiology medical devices form the backbone of modern diagnostic medicine in India. From the X-ray machine in a rural health subcentre to the superconducting MRI system in a quaternary care hospital, from the hand-held Doppler used to monitor foetal heart beats to the AI-powered computer-aided detection software that flags lung nodules on CT images — radiology devices span an extraordinary range of technology, clinical function, and patient risk. CDSCO has classified all 66 notified devices in this category under the Medical Devices Rules, 2017, and every manufacturer and importer of these devices must hold a valid CDSCO license before those devices can be legally placed on the Indian market.
This guide provides the complete classification reference for radiology medical devices under CDSCO — every device, its risk class, its intended use, and the license type it requires. Whether you are a domestic manufacturer planning an MD5 or MD9 application, a foreign manufacturer preparing an MD15 import application, or a regulatory consultant confirming classification before starting a client's licensing process, this is the definitive 2026 reference.
📑 Quick Navigation
- CDSCO Device Classification Framework
- 23 Notified Medical Device Categories Under MDR 2017
- Radiology Medical Devices — Regulatory Overview
- Classification Summary by Risk Class
- Complete List: All 66 CDSCO Notified Radiology Medical Devices
- License Types for Radiology Medical Devices
- How Rego Services Supports Radiology Device Manufacturers and Importers
- Frequently Asked Questions
CDSCO Device Classification Framework
The Medical Devices Rules, 2017 establish India's risk-based classification system for medical devices, organising all notified devices into four classes based on the level of risk they present to the patient and user. The classification of a device determines its licensing pathway, the authority that issues the license, the depth of technical documentation required, and the applicable government fees.
Non-invasive or limited-contact devices with the lowest patient risk profile. For radiology, this includes positioning aids, film accessories, calibration sources, and nuclear medicine support equipment. Class A sterile or measuring devices require an MD5 license from the State Licensing Authority.
Devices with limited body interaction or active diagnostic functions whose measurement output influences clinical decisions. In radiology, this covers general-purpose ultrasound systems, pulsed doppler and echo devices, radionuclide dose calibrators, and flexible ultrasound endoscopes. Require MD5 license from the State Licensing Authority.
Devices whose malfunction could cause serious harm or whose radiation exposure carries significant patient risk. The largest class in radiology — covering angiographic X-ray systems, mammography, fluoroscopy, MRI machines, nuclear tomography, emission CT, foetal monitors, Doppler catheters, and radiological AI software. Require MD9 license from CDSCO Headquarters.
Highest-risk devices with significant potential for harm if they fail or are used incorrectly. In the radiology category, the transilluminator for breast evaluation — a device using near-infrared light to characterise breast tissue for cancer diagnosis — is the Class D device. Require MD9 license from CDSCO Headquarters with the most extensive documentation requirements.
23 Notified Medical Device Categories Under MDR 2017
CDSCO has organised all notified medical devices under the Medical Devices Rules, 2017 into 23 broad clinical categories. Radiology is one of these 23 categories. Understanding the full structure helps manufacturers and importers locate their specific device within the regulatory framework and identify the correct classification schedule to apply.
| S. No. | Medical Device Category | S. No. | Medical Device Category |
|---|---|---|---|
| 1 | Anaesthesiology | 13 | Ophthalmology |
| 2 | Cardiovascular | 14 | Orthopaedic |
| 3 | Dental | 15 | Pain Management |
| 4 | Dermatological and Plastic Surgery | 16 | Personal Protective Equipment |
| 5 | ENT | 17 | Physical Support |
| 6 | Gastroenterology | 18 | Radiotherapy |
| 7 | General Hospital / Orthopaedic Instruments | 19 | Rehabilitation |
| 8 | Radiology | 20 | Respiratory |
| 9 | Nephrology and Renal Care | 21 | Software |
| 10 | Neurological | 22 | Urology |
| 11 | Obstetrical and Gynaecological | 23 | Non-sterile, Non-Powdered, Hand-Held Surgical Instruments |
| 12 | Oncology |
Radiology Medical Devices — Regulatory Overview
The radiology category under MDR 2017 encompasses a remarkably broad range of technologies — from passive accessories (radiographic film, cassette holders, patient cradles) at the Class A end, to AI-powered diagnostic software and invasive ultrasound catheters in the middle classes, to devices using near-infrared radiation for cancer characterisation at the Class D level. What connects all 66 devices is their application in medical imaging, diagnostic measurement, or radiation detection for clinical purposes.
The classification logic within the radiology category follows the general MDR 2017 rules: devices are classified based on their intended use, their mechanism of action, whether they emit or detect ionising radiation, how directly they interact with the body, and what the clinical consequence of their failure would be. A radiographic film (Class A) is a passive recording medium — its failure disrupts workflow but does not directly harm patients. An angiographic X-ray system (Class C) exposes patients to ionising radiation while accessing the cardiovascular system — its failure can have direct patient consequences.
Classification Summary by Risk Class
Before presenting the complete 66-device classification list, this overview organises the devices by risk class to help manufacturers and importers quickly identify which category their specific product falls into.
- Scintillation (gamma) camera
- Nuclear rectilinear scanner
- Nuclear uptake probe
- Nuclear whole body scanner & counter
- Nuclear scanning bed
- Nuclear sealed calibration source
- Nuclear ECG synchronizer
- Positron camera
- Radiographic film marking system
- Diagnostic X-ray high voltage generator
- Diagnostic X-ray tube housing assembly
- Diagnostic X-ray tube mount
- Radiographic film, cassette holder, illuminator, grid
- Radiologic patient cradle & table
- Medical image storage device
- Radiographic ECG/respirator synchronizer
- Bone sonometer
- Radionuclide dose calibrator
- Nonfetal ultrasonic monitor
- Ultrasonic pulsed doppler imaging system
- Ultrasonic pulsed echo imaging system
- Diagnostic ultrasonic transducer
- Spot-film device
- Pneumoencephalographic chair
- Radiographic film cassette
- Radiographic film/cassette changer
- General-purpose ultrasound imaging system
- Flexible ultrasound colonoscope
- Flexible ultrasound duodenoscope
- Flexible ultrasound gastroduodenoscope
- Flexible ultrasound laparoscope
- Flexible ultrasound bronchoscope
- Bladder ultrasound imaging transducer
- Medical image analyzer (CADe software)
- Bone densitometer
- Emission computed tomography system
- Fluorescent scanner
- Nuclear tomography system
- Radionuclide rebreathing system
- Angiographic X-ray system
- Diagnostic X-ray beam-limiting device
- Cine or spot fluorographic X-ray camera
- Electrostatic X-ray imaging system
- Image-intensified fluoroscopic X-ray system
- Mammographic X-ray system
- Photofluorographic X-ray system
- Automatic radiographic film processor
- Full-body MRI (permanent, resistive, superconducting)
- Foetal cardiac monitor
- Foetal Doppler system
- Blood flowmeter catheter (Doppler)
- Radiological CAD triage software
- Radiological computer-assisted diagnostic software (cancer)
- Transilluminator for breast evaluation — a device using low-intensity visible light and near-infrared radiation (approximately 700–1050 nm) transmitted through breast tissue to visualise translucent tissue for the diagnosis of cancer and other conditions
CDSCO License for Anaesthesia Medical Devices in India 2026
Like radiology devices, anaesthesia medical devices span all four CDSCO risk classes. This guide covers the classification framework and licensing pathways for anaesthesia devices — a useful parallel reference for manufacturers whose products may interact with both radiology and anaesthesia clinical contexts.
Complete List: All 66 CDSCO Notified Radiology Medical Devices
The following table presents all 66 radiology medical devices notified by CDSCO on 13 September 2021 under the Medical Devices Rules, 2017. Each entry includes the device's official name, its intended use as defined by CDSCO, and its assigned risk class. Use this table to confirm the classification of your specific device before beginning the licensing process.
| No. | Device Name | Intended Use (as per CDSCO MDR 2017) | Class |
|---|---|---|---|
| 1 | Scintillation (gamma) camera | Images the distribution of radionuclides in the body by means of a photon radiation detector. | Class A |
| 2 | Positron camera | Images the distribution of positron-emitting radionuclides in the body. | Class A |
| 3 | Nuclear whole body counter | Measures the amount of radionuclides in the entire body. | Class A |
| 4 | Bone densitometer | Measures bone density and mineral content by X-ray or gamma ray transmission through bone and adjacent tissues for medical purposes. | Class C |
| 5 | Bone sonometer | Transmits ultrasound energy into the human body to measure acoustic properties of bone that indicate overall bone health and fracture risk. | Class B |
| 6 | Emission computed tomography system | Detects the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produces cross-sectional images through computer reconstruction of data. | Class C |
| 7 | Fluorescent scanner | Measures induced fluorescent radiation in the body by exposing the body to certain X-rays or low-energy gamma rays. | Class C |
| 8 | Nuclear rectilinear scanner | Images the distribution of radionuclides in the body using a detector whose position moves in two directions with respect to the patient. | Class A |
| 9 | Nuclear tomography system | Detects nuclear radiation in the body and produces images of a specific cross-sectional plane by blurring or eliminating detail from other planes. | Class C |
| 10 | Nuclear uptake probe | Measures the amount of radionuclide taken up by a particular organ or body region. | Class A |
| 11 | Nuclear whole body scanner | Measures and images the distribution of radionuclides in the body using a wide-aperture detector whose position moves in one direction with respect to the patient. | Class A |
| 12 | Nuclear scanning bed | An adjustable bed intended to support a patient during a nuclear medicine procedure. | Class A |
| 13 | Radionuclide dose calibrator | A radiation detection device intended to assay radionuclides before their administration to patients. | Class B |
| 14 | Radionuclide rebreathing system | Contains a gaseous or volatile radionuclide or radionuclide-labelled aerosol and allows it to be respired by the patient during nuclear medicine ventilatory tests. | Class C |
| 15 | Nuclear sealed calibration source | An encapsulated reference radionuclide intended for calibration of medical nuclear radiation detectors. | Class A |
| 16 | Nuclear ECG synchronizer | Relates the time of image formation to the cardiac cycle during the production of dynamic cardiac images in nuclear radiology. | Class A |
| 17 | Nonfetal ultrasonic monitor | Projects a continuous high-frequency sound wave into body tissue to determine frequency changes (Doppler shift) in the reflected wave; used to investigate nonfetal blood flow and tissue motion. | Class B |
| 18 | Ultrasonic pulsed doppler imaging system | Combines continuous wave Doppler-effect technology with pulsed-echo effect technology to determine stationary body tissue characteristics or dynamic tissue characteristics such as blood or tissue velocity. | Class B |
| 19 | Ultrasonic pulsed echo imaging system | Projects a pulsed sound beam into body tissue to determine the depth or location of tissue interfaces and measure acoustic pulse transit time. | Class B |
| 20 | Diagnostic ultrasonic transducer | Made of piezoelectric material that converts electrical signals into acoustic signals (and vice versa) for use in diagnostic ultrasonic medical devices. | Class B |
| 21 | Angiographic X-ray system | Intended for radiologic visualisation of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. | Class C |
| 22 | Diagnostic X-ray beam-limiting device | A collimator, cone, or aperture intended to restrict the dimensions of a diagnostic X-ray field by limiting the size of the primary X-ray beam. | Class C |
| 23 | Cine or spot fluorographic X-ray camera | Photographs diagnostic images produced by X-rays with an image intensifier. | Class C |
| 24 | Electrostatic X-ray imaging system | Uses an electrostatic field across a semiconductive plate or gas-filled chamber to convert a pattern of X-radiation into an electrostatic image and then into a visible image. | Class C |
| 25 | Radiographic film marking system | Adds identification and other information onto radiographic film by means of exposure to visible light. | Class A |
| 26 | Image-intensified fluoroscopic X-ray system | Visualises anatomical structures by converting a pattern of X-radiation into a visible image through electronic amplification. | Class C |
| 27 | Non-image-intensified fluoroscopic X-ray system | Visualises anatomical structures using a fluorescent screen to convert a pattern of X-radiation into a visible image. | Class C |
| 28 | Spot-film device | An electromechanical component of a fluoroscopic X-ray system that positions a radiographic film cassette to obtain radiographs during fluoroscopy. | Class B |
| 29 | Diagnostic X-ray high voltage generator | Supplies and controls the electrical energy applied to a diagnostic X-ray tube for medical purposes. | Class A |
| 30 | Mammographic X-ray system | Produces radiographs of the breast. | Class C |
| 31 | Photofluorographic X-ray system | Includes a fluoroscopic X-ray unit and a camera intended to produce, then photograph, a fluoroscopic image of the body. | Class C |
| 32 | Diagnostic X-ray tube housing assembly | An X-ray generating tube encased in a radiation-shielded housing intended for diagnostic purposes. | Class A |
| 33 | Diagnostic X-ray tube mount | Supports and positions the diagnostic X-ray tube housing assembly for a medical radiographic procedure. | Class A |
| 34 | Pneumoencephalographic chair | Supports and positions a patient during pneumoencephalography (X-ray imaging of the brain). | Class B |
| 35 | Radiologic patient cradle | A support device for rotational positioning about the longitudinal axis of a patient during radiologic procedures. | Class A |
| 36 | Radiographic film | A thin sheet of radiotransparent material coated with photographic emulsion intended to record images during diagnostic radiologic procedures. | Class A |
| 37 | Radiographic film cassette | Holds a radiographic film in close contact with an X-ray intensifying screen and provides a light-proof enclosure for direct exposure of radiographic film during diagnostic X-ray procedures. | Class B |
| 38 | Radiographic film/cassette changer | Moves a radiographic film or cassette between X-ray exposures and positions it during exposure during a radiologic procedure. | Class B |
| 39 | Radiographic film/cassette changer programmer | Controls the operations of a film or cassette changer during serial medical radiography. | Class B |
| 40 | Wall-mounted radiographic cassette holder | Holds and positions radiographic cassettes for a radiographic exposure for medical use. | Class A |
| 41 | Radiographic film illuminator | Contains a visible light source covered with a translucent front for viewing medical radiographs. | Class A |
| 42 | Automatic radiographic film processor | Automatically and continuously develops, fixes, washes, and dries film exposed for medical purposes. | Class C |
| 43 | Radiographic grid | Consists of alternating radiolucent and radiopaque strips placed between the patient and the image receptor to reduce scattered radiation reaching the image receptor. | Class A |
| 44 | Radiographic head holder | Positions the patient's head during a radiographic procedure. | Class A |
| 45 | Radiologic quality assurance instrument | Measures a physical characteristic associated with another radiologic device for medical purposes. | Class A |
| 46 | Radiographic intensifying screen | A thin radiolucent sheet coated with a luminescent material that transforms X-ray photons into visible light for exposing radiographic film. | Class A |
| 47 | Radiographic ECG/respirator synchronizer | Coordinates an X-ray film exposure with the signal from an ECG or respirator at a predetermined phase of the cardiac or respiratory cycle. | Class A |
| 48 | Radiologic table | Supports a patient during radiologic procedures; may be fixed or tilting, and may be electrically powered. | Class A |
| 49 | Transilluminator for breast evaluation | Uses low-intensity visible light and near-infrared radiation (approximately 700–1050 nm) transmitted through the breast to visualise translucent tissue for the diagnosis of cancer and other conditions. | Class D |
| 50 | Medical image storage device | Provides electronic storage and retrieval functions for medical images; examples include magnetic and optical discs, magnetic tape, and digital memory. | Class A |
| 51 | Radiological CAD software for cancer lesions | An image processing prescription device that aids in characterising lesions suspicious for cancer identified on acquired medical images (MRI, mammography, radiography, CT) and provides information about lesions to the user. | Class C |
| 52 | Medical image analyzer (CADe) | A prescription device incorporating pattern recognition and data analysis that identifies, marks, or highlights portions of a radiology image that may reveal abnormalities during clinician interpretation; includes CADe devices for mammography, ultrasound breast lesions, radiograph lung nodules, and dental caries detection. | Class B |
| 53 | Radiological CAD triage and notification software | An image processing prescription device that aids in prioritisation and triage of radiological medical images and notifies clinicians of the availability of time-sensitive images based on computer-aided image analysis. | Class C |
| 54 | Full-body MRI system, permanent magnet | A general-purpose MRI system designed to scan any targeted area of the body, including a permanent magnet assembly. | Class C |
| 55 | Full-body MRI system, resistive magnet | A diagnostic general-purpose MRI system for full-body imaging, including a resistive magnet assembly. | Class C |
| 56 | Full-body MRI system, superconducting magnet | A diagnostic general-purpose MRI system for full-body imaging, including a superconducting magnet assembly. | Class C |
| 57 | Foetal cardiac monitor | A mains electricity (AC-powered) device designed to detect, measure, and display foetal heart activity during the perinatal period. | Class C |
| 58 | Foetal Doppler system | A portable, hand-held, battery-powered device assembly designed to noninvasively detect foetal heart beats using ultrasound/Doppler technology applied to the surface of the pregnant woman's abdomen. | Class C |
| 59 | Flexible ultrasound colonoscope | An endoscope with a flexible inserted portion for visual examination and treatment of the entire colon, inserted through the anus during colonoscopy. | Class B |
| 60 | Flexible ultrasound duodenoscope | An endoscope with a flexible inserted portion, combined with an ultrasound probe, for visual examination and treatment of the duodenum, inserted through the mouth. | Class B |
| 61 | Flexible ultrasound gastroduodenoscope | An endoscope with a flexible inserted portion, combined with an ultrasound probe, for visual examination and treatment of the upper GI tract including the oesophagus, stomach, and duodenum. | Class B |
| 62 | Flexible ultrasound laparoscope | An endoscope with a flexible inserted portion, combined with an ultrasound probe, for visual examination, treatment, and ultrasonic imaging of the abdominal/retroperitoneal cavity and its organs. | Class B |
| 63 | Flexible ultrasound bronchoscope | An endoscope with a flexible inserted portion for visual examination and treatment of the trachea, bronchi, and lungs, inserted through the mouth or nose. | Class B |
| 64 | Bladder ultrasound imaging transducer | An ultrasound imaging transducer assembly designed to be positioned within the bladder, either manually or under endoscopic guidance, to steer, focus, and detect the ultrasound beam and resulting echoes. | Class B |
| 65 | Blood flowmeter catheter, Doppler | A flexible tube inserted into the lumen of a blood vessel to determine blood-flow velocity by measuring the ultrasonic frequency shift between transmitted and reflected signals (Doppler principle). | Class C |
| 66 | General-purpose ultrasound imaging system | A stationary or mobile assembly designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal ultrasound imaging procedures including cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging. | Class B |
License Types for Radiology Medical Devices
The CDSCO license required for a radiology medical device depends on whether the company is manufacturing or importing, and — for manufacturers — the risk class of the specific device. The class determines the license type, the reviewing authority, and the government fee.
How to Build a Compliant CDSCO Device Master File (DMF) in 2026
For Class C and D radiology devices — MRI machines, angiographic X-ray systems, mammography systems, and radiological AI software — the Device Master File is the most scrutinised document in the MD9 application. This guide explains the required sections, how CDSCO reviewers use the DMF, and how to structure it for both submission and audit readiness.
How Rego Services Supports Radiology Device Manufacturers and Importers
Rego Services Private Limited provides end-to-end regulatory support for manufacturers and importers of radiology medical devices across all classes — from basic Class A radiographic accessories through Class B ultrasound systems, Class C MRI and X-ray systems, and Class D breast evaluation devices. Our team brings regulatory experience with both the State Licensing Authority pathway (MD5) and the CDSCO Headquarters pathway (MD9), and understands the specific technical documentation requirements for radiation-emitting, software-based, and ultrasound diagnostic devices.
- Device classification confirmation — We confirm the CDSCO class of your radiology device against the MDR 2017 schedule, identify any ambiguities in classification (particularly for new AI-assisted or hybrid imaging technologies), and determine the correct license pathway before any documentation effort begins.
- License strategy development — We map the complete regulatory pathway — MD5, MD9, or MD15 — with a realistic timeline, fee estimate, and document preparation plan tailored to your specific radiology device and business situation.
- ISO 13485 certification support — ISO 13485 certification is mandatory for MD5 and MD9 applications. If not yet in place, we support the full certification process coordinated with the CDSCO license application timeline.
- Device Master File preparation — We prepare comprehensive, CDSCO-compliant Device Master Files for radiology devices — including radiation safety data, performance testing, software validation records (for AI and digital imaging devices), IEC 60601 electrical safety documentation, and risk management files under ISO 14971.
- Plant Master File preparation — We prepare Plant Master Files that accurately describe the manufacturing facility at the level of detail required by State Licensing Authority and CDSCO central reviewers for radiology device applications.
- SUGAM portal submission — We manage the complete SUGAM portal submission process — account registration, form completion, document upload, fee payment, and formal application submission.
- Query response and inspection preparation — We coordinate responses to SLA or CDSCO queries and prepare the facility for inspection, with particular focus on the technical aspects of radiology device applications that most frequently generate reviewer comments.
- MD15 import support for foreign manufacturers — We act as or support the appointment of the Indian Authorised Agent required for MD15 applications, and manage the full import license application process including Free Sale Certificate procurement coordination.
Frequently Asked Questions
Are all 66 radiology devices listed mandatory to license?
All 66 devices in the CDSCO radiology medical device schedule are notified devices under the Medical Devices Rules, 2017 and require either a manufacturing or import license before they can be legally manufactured or imported for commercial sale in India. There are no non-notified devices in the radiology category — every device on the list requires a valid CDSCO license. Companies currently manufacturing or importing any of these devices without the appropriate license should seek regulatory advice immediately to understand their options for achieving compliance.
Does AI-based radiology software require a CDSCO license?
Yes. Two AI-based radiology software categories are specifically notified: the medical image analyzer (CADe) at Class B, and the radiological computer-assisted diagnostic software for cancer lesions and the radiological CAD triage and notification software both at Class C. Manufacturers or importers of AI-assisted radiology software that matches these descriptions require the appropriate CDSCO license. For AI software not directly matching these listed categories, individual classification confirmation with CDSCO is recommended before proceeding with any licensing application.
Does each type of MRI machine require a separate CDSCO license?
The three full-body MRI system types — permanent magnet, resistive magnet, and superconducting magnet — are individually listed in CDSCO's radiology device schedule, each as Class C. Where a manufacturer or importer offers all three types, each must be separately declared in the application with its own device description and technical documentation. Depending on how distinct the devices are, they may be covered under a single MD9 or MD15 license (with per-device fees applying for each) or may require separate applications. Rego Services advises on the most efficient approach to multi-device radiology applications.
Is a Free Sale Certificate required for importing radiology medical devices into India?
Yes. For MD15 import license applications for radiology medical devices, a Free Sale Certificate or equivalent marketing authorisation document from the regulatory authority in the country of origin is typically required as part of the supporting documentation. The specific requirements vary depending on the device class and whether the foreign manufacturer has existing regulatory authorisation in a recognised reference market. Rego Services advises on country-of-origin documentation requirements as part of MD15 application preparation for radiology devices.
✓ Key Takeaways
- CDSCO notified 66 radiology medical devices on 13 September 2021 under the Medical Devices Rules, 2017 — all require a valid CDSCO license before manufacture or import for commercial sale in India
- Radiology devices span all four CDSCO risk classes (A through D) — from passive accessories like radiographic film (Class A) through ultrasound systems (Class B), MRI machines and X-ray systems (Class C), to breast transilluminators (Class D)
- Class A and B radiology devices require an MD5 license (Form MD3) from the State Licensing Authority — fee: Rs. 5,000 + Rs. 500 per device
- Class C and D radiology devices require an MD9 license (Form MD7) from CDSCO Headquarters — fee: Rs. 50,000 + Rs. 1,000 per device
- Importers of any class of radiology device require an MD15 license (Form MD14) from CDSCO, with a mandatory Indian Authorised Agent for foreign manufacturers
- All three license types are valid indefinitely, subject to a retention fee every 5 years
- The majority of the most commercially significant radiology devices — MRI machines, angiographic X-ray systems, mammography systems, fluoroscopic systems, foetal monitors, and AI diagnostic software — are Class C, requiring the MD9 pathway and CDSCO Headquarters review
- The Class D transilluminator for breast evaluation is the only Class D device in the radiology category — it requires the same MD9 pathway as Class C but with the most extensive documentation requirements
- AI-based radiology software — CADe systems, computer-assisted diagnostic software, and triage notification software — is specifically notified and regulated under MDR 2017, classified at Class B or Class C depending on function
Your Next Step
The CDSCO classification of radiology medical devices under MDR 2017 is both detailed and consequential — the difference between Class B and Class C can mean the difference between a State Licensing Authority application at Rs. 5,000 and a CDSCO Headquarters application at Rs. 50,000, with significantly different documentation depth, review timelines, and inspection requirements. Getting the classification right before beginning the licensing process is not merely good practice — it is the prerequisite that determines every subsequent step.
For manufacturers and importers across the radiology spectrum — from ultrasound equipment suppliers and MRI importers to nuclear medicine device companies and AI diagnostic software developers — Rego Services provides the classification confirmation, licensing strategy, document preparation, and application management that transforms a regulatory requirement into a completed CDSCO license.
Contact Rego Services today to confirm the CDSCO classification of your radiology medical device and begin the licensing process with a clear, accurate regulatory plan.