- Class-wise Registration: Covers Class A, B, C & D MRI machines — all product types, risk tiers, and applicable MDR 2017 forms
- All License Types: Import (MD-14/MD-15), Wholesale (MD-41/MD-42), Manufacturing Class A/B (MD-3/MD-5) and Class C/D (MD-7/MD-9)
- Step-by-Step Process: Documents checklist, SUGAM portal filing, timelines, fees, and renewal requirements explained in plain language
- 2026 Compliance Ready: Updated to reflect current MDR 2017 enforcement, SUGAM portal flows, and CDSCO processing timelines
CDSCO License for MRI Machine
In India, MRI machines are regulated as medical devices under the Medical Devices Rules (MDR) 2017 by the Central Drugs Standard Control Organization (CDSCO). Importers must file Form MD-14 and obtain an import license via Form MD-15 on the SUGAM portal. Wholesale distributors apply through MD-41 and receive a grant in MD-42.
Manufacturers of Class A/B devices use MD-3 (application) and MD-5 (license), while Class C/D manufacturers use MD-7 (application) and MD-9 (license). MRI machines typically fall under Class C or Class D depending on field strength and clinical use. All applications are submitted online via the SUGAM portal with prescribed fees.
What Is the CDSCO License for an MRI Machine?
The CDSCO license for MRI machines is a mandatory regulatory approval issued by the Central Drugs Standard Control Organisation (CDSCO) under the Ministry of Health and Family Welfare, Government of India. Any entity that imports, manufactures, or distributes an MRI machine in India must hold a valid CDSCO license before commencing commercial activity.
MRI (Magnetic Resonance Imaging) machines are classified as notified medical devices under Schedule I of the Medical Devices Rules, 2017 (MDR 2017). Depending on the risk classification — Class A (low risk) to Class D (high risk) — the applicable license form, regulatory pathway, and documentation requirements differ significantly.
Failure to obtain the CDSCO license for MRI machine can result in import seizure, penalties under the Drugs and Cosmetics Act, 1940, and legal prosecution. Silvereye Certifications has helped hundreds of importers and manufacturers obtain CDSCO approvals with zero rejections.
MRI Machine Classification Under MDR 2017: Class A, B, C & D
CDSCO classifies MRI machines and their sub-components under four risk-based categories. Below is a comprehensive classification reference:
Class A — Low Risk MRI-Related Devices
| Device / Product Name | Classification | Risk Level | License Required |
| MRI Patient Positioning Aids (non-powered cushions, pads) | Class A | Low | MD-5 (Manufacturing) |
| MRI-Compatible Stethoscopes (passive, non-electronic) | Class A | Low | MD-5 (Manufacturing) |
| MRI Room Signage and Warning Systems (passive) | Class A | Low | MD-5 (Manufacturing) |
| MRI-Compatible Wheelchair (non-powered, aluminium frame) | Class A | Low | MD-5 / MD-15 (Import) |
| MRI-Safe Stretchers and Transport Beds (non-powered) | Class A | Low | MD-5 / MD-15 (Import) |
| MRI Coil Storage Stands and Racks (passive accessories) | Class A | Low | MD-5 (Manufacturing) |
| MRI-Compatible IV Poles (non-electronic) | Class A | Low | MD-5 / MD-15 (Import) |
| MRI Room Door Interlocks (manual, non-powered) | Class A | Low | MD-5 (Manufacturing) |
Note: Class A devices do not require a manufacturing license from CDSCO for most categories; however, importers must still obtain MD-15.
Class B — Low-Moderate Risk MRI-Related Devices
| Device / Product Name | Classification | Risk Level | License Required |
| MRI-Compatible Infusion Pump (external, non-implantable) | Class B | Low-Moderate | MD-5 / MD-15 |
| MRI-Compatible Patient Monitoring System (basic vitals) | Class B | Low-Moderate | MD-5 / MD-15 |
| MRI Coil Cleaning and Maintenance Systems | Class B | Low-Moderate | MD-5 / MD-15 |
| MRI-Compatible Pulse Oximeter | Class B | Low-Moderate | MD-5 / MD-15 |
| MRI-Safe Blood Pressure Monitor (compatible) | Class B | Low-Moderate | MD-5 / MD-15 |
| MRI-Compatible ECG Electrodes and Leads | Class B | Low-Moderate | MD-5 / MD-15 |
| RF Shielding Materials for MRI Rooms (installed) | Class B | Low-Moderate | MD-5 / MD-15 |
| Gradient Coil Cooling Systems (ancillary) | Class B | Low-Moderate | MD-5 / MD-15 |
| MRI-Compatible Syringe Pump | Class B | Low-Moderate | MD-5 / MD-15 |
| MRI-Compatible Anaesthesia Delivery System (basic) | Class B | Low-Moderate | MD-5 / MD-15 |
Class C — Moderate-High Risk MRI Machines & Systems
| Device / Product Name | Classification | Risk Level | License Required |
| Closed-Bore MRI System (1.5T) — Whole Body Diagnostic | Class C | Moderate-High | MD-9 / MD-15 |
| Open MRI System (0.3T – 1.0T) — Musculoskeletal Imaging | Class C | Moderate-High | MD-9 / MD-15 |
| Extremity MRI Scanner (dedicated limb imaging, up to 1.0T) | Class C | Moderate-High | MD-9 / MD-15 |
| MRI-Compatible Biopsy System (MRI-guided needle guidance) | Class C | Moderate-High | MD-9 / MD-15 |
| Dedicated Breast MRI System | Class C | Moderate-High | MD-9 / MD-15 |
| Cardiac MRI System (1.5T optimised for cardiac protocols) | Class C | Moderate-High | MD-9 / MD-15 |
| MRI-Compatible Ventilator (ICU-grade, MRI-conditional) | Class C | Moderate-High | MD-9 / MD-15 |
| MRI Gradient Coil Assembly (primary imaging component) | Class C | Moderate-High | MD-9 / MD-15 |
| MRI Radiofrequency (RF) Body Coil | Class C | Moderate-High | MD-9 / MD-15 |
| MRI Head Coil (receive/transmit, multi-channel) | Class C | Moderate-High | MD-9 / MD-15 |
| MRI Knee Coil / Shoulder Coil / Wrist Coil (surface coils) | Class C | Moderate-High | MD-9 / MD-15 |
| MRI-Compatible Interventional Device System | Class C | Moderate-High | MD-9 / MD-15 |
| MRI Spectroscopy System (1H MRS, metabolic imaging) | Class C | Moderate-High | MD-9 / MD-15 |
| Functional MRI (fMRI) System | Class C | Moderate-High | MD-9 / MD-15 |
| Diffusion Tensor Imaging (DTI) MRI System | Class C | Moderate-High | MD-9 / MD-15 |
| MRI-Compatible Physiological Monitoring System (advanced) | Class C | Moderate-High | MD-9 / MD-15 |
| MRI Cryogen Supply and Helium Recovery System | Class C | Moderate-High | MD-9 / MD-15 |
| MRI Magnetic Shielding Assembly (passive shim system) | Class C | Moderate-High | MD-9 / MD-15 |
| MRI-Compatible Contrast Media Injector | Class C | Moderate-High | MD-9 / MD-15 |
| 3.0T Closed-Bore MRI System — Multi-Parametric Imaging | Class C | Moderate-High | MD-9 / MD-15 |
Class D — High Risk MRI Systems (Highest Regulatory Scrutiny)
| Device / Product Name | Classification | Risk Level | License Required |
| Ultra-High Field MRI System (7.0T and above) — Research & Clinical | Class D | High | MD-9 / MD-15 |
| Intraoperative MRI (iMRI) System — Integrated Surgical Suite | Class D | High | MD-9 / MD-15 |
| Neonatal/Paediatric MRI System (specialised, incubator-integrated) | Class D | High | MD-9 / MD-15 |
| MRI-Guided Focused Ultrasound (MRgFUS) Therapeutic System | Class D | High | MD-9 / MD-15 |
| MRI-Compatible Radiation Therapy System (MR-Linac) | Class D | High | MD-9 / MD-15 |
| MRI-Compatible Neurostimulation Delivery System (implant-interfacing) | Class D | High | MD-9 / MD-15 |
| Real-Time MRI-Guided Intervention System (intraoperative navigation) | Class D | High | MD-9 / MD-15 |
| Hybrid PET-MRI Scanner (simultaneous acquisition) | Class D | High | MD-9 / MD-15 |
| MRI-Compatible Cardiac Ablation System (electrophysiology lab) | Class D | High | MD-9 / MD-15 |
| Fetal MRI System (specialised obstetric imaging, high-field) | Class D | High | MD-9 / MD-15 |
Important: For Class D devices, CDSCO requires a pre-submission meeting with the Central Licencing Authority (CLA) and enhanced clinical evaluation data. Technical documentation must include full risk management files per ISO 14971.
Types of CDSCO License for MRI Machine: Which Form Do You Need?
| License Type | Applicant | Application Form | Grant Form | Applicable Risk Class |
| Import License | Importers / Indian Authorised Agents | MD-14 | MD-15 | Class A, B, C, D |
| Wholesale/Distribution License | Wholesale Distributors | MD-41 | MD-42 | Class A, B, C, D |
| Manufacturing License (Class A/B) | Indian Manufacturers | MD-3 | MD-5 | Class A, B |
| Manufacturing License (Class C/D) | Indian Manufacturers | MD-7 | MD-9 | Class C, D |
| Loan / Test License | R&D / Clinical Trial Sites | MD-16 | MD-17 | Class C, D |
MD-14 Application and MD-15 Import License for MRI Machine Importers
Any company importing an MRI machine into India — whether a Class C 1.5T closed-bore scanner or a Class D 7T research system — must obtain an import license under Form MD-15. The process begins with an application on Form MD-14 submitted on the SUGAM online portal.
Who Needs MD-15 for MRI Machines?
- Overseas MRI manufacturers selling into India through an Indian authorised agent
- Trading companies importing MRI systems for resale to hospitals or diagnostics centres
- Hospital procurement teams importing MRI equipment directly for their own use
- Distributors importing MRI coils, accessories, and sub-assemblies separately classified under MDR 2017
Documents Required for MD-14 / MD-15 Application
| Document | Requirement |
| Application on Form MD-14 (SUGAM portal) | Mandatory — filed online by the Indian authorised agent |
| Manufacturing site approval / CE / FDA / TGA clearance of the MRI system | Required for Class C and D; supports technical credibility |
| Free Sale Certificate from country of origin | For Class C/D imported MRI machines |
| Technical documentation / Device Master File | Summary of design, safety, performance, and EMC data |
| ISO 13485 certificate of the manufacturer | Quality management system evidence |
| IEC 60601-2-33 compliance evidence (MRI safety standard) | Critical for Class C and D MRI machines |
| Undertaking from Indian authorised agent | Accepting liability for product safety and post-market surveillance |
| Power of Attorney from foreign manufacturer to Indian agent | Notarised and apostilled |
| Site plan / storage facility details of the importer | Warehouse and cold-chain details if applicable |
| Clinical evaluation report or clinical data | Mandatory for Class C/D MRI systems |
| Risk management file per ISO 14971 | Required for Class C and D |
| Declaration of conformity from manufacturer | Self-certification of compliance |
| Labelling and IFU samples | As per MDR 2017 Schedule IV requirements |
| Government fee challan | As per Second Schedule to MDR 2017 |
MD-14 / MD-15 Process Flow
- Create account and register Indian Authorised Agent on SUGAM portal
- Prepare and upload all technical and quality documents in prescribed format
- File Form MD-14 online and pay government fee via challan
- CDSCO scrutiny — deficiency letter issued within 30 days if documents are incomplete
- Respond to queries and upload additional data within the stipulated timeframe
- CDSCO grants Form MD-15 (Import License) — valid for the lifetime of the product (subject to renewal conditions)
Government Fee for MD-15 MRI Import License
| Risk Class | Application Fee (INR) | License Grant Fee (INR) |
| Class A | 3,000 | Nil (no grant fee) |
| Class B | 5,000 | 3,000 |
| Class C | 15,000 | 10,000 |
| Class D | 25,000 | 20,000 |
Note: Fees are indicative based on MDR 2017 Second Schedule. Always confirm current fees on the SUGAM portal before filing.
MD-41 Application and MD-42 Wholesale License for MRI Machine Distributors
Any entity distributing MRI machines to hospitals, diagnostics centres, or sub-distributors in India must hold a CDSCO wholesale distribution license issued on Form MD-42. The application is filed on Form MD-41 via the SUGAM portal and is processed by the State Licensing Authority (SLA) in most cases.
Who Needs MD-42 for MRI Machines?
- National or regional distributors of imported MRI equipment
- Hospital equipment supply companies reselling MRI systems to end-users
- Service partners who supply MRI coils, accessories, and replacement parts wholesale
- Dealers supplying MRI-related consumables (contrast injectors, coils) in bulk
Documents Required for MD-41 / MD-42 Wholesale License
| Document | Requirement |
| Form MD-41 application (via SUGAM or SLA portal) | Mandatory |
| Proof of registered office / godown address | GST registration, electricity bill, or lease agreement |
| Valid import license (MD-15) of the product being distributed | Required to prove the product is legally imported |
| Qualified person — details of technically competent person | Pharmacist or science graduate with 1-year experience preferred |
| Storage facility layout plan | Showing adequate space and conditions for medical device storage |
| Undertaking for post-market surveillance | Declaration to maintain distribution records and recall readiness |
| Government fee payment challan | Per MDR 2017 Schedule |
MD-41 / MD-42 Process: Step-by-Step
- Apply on Form MD-41 via SUGAM portal / State Licensing Authority online system
- Upload premises proof, qualified person credentials, and product-related licenses
- Pay prescribed government fee
- SLA inspection of storage premises (may be required for Class C/D equipment)
- Wholesale license MD-42 granted — valid for 5 years, renewable
MD-3 Application and MD-5 Manufacturing License for Class A/B MRI Devices
Indian companies manufacturing Class A or Class B MRI-related devices — such as MRI-compatible accessories, positioning aids, MRI-safe monitoring systems, or ancillary equipment — must apply for a manufacturing license on Form MD-3 and receive the grant in Form MD-5 from the State Licensing Authority (SLA).
Who Needs MD-3 / MD-5?
- Indian manufacturers of Class A MRI room accessories, transport aids, and passive devices
- Manufacturers of Class B MRI-compatible monitors, pumps, and ECG-compatible devices
- OEM suppliers manufacturing ancillary MRI room components for export or domestic supply
Documents Required for MD-3 Manufacturing Application (Class A/B)
| Document | Requirement |
| Form MD-3 application | Filed with SLA (State Licensing Authority) |
| Site Master File / Plant layout | Manufacturing premises details including clean room, assembly, QC areas |
| ISO 13485 Quality Management System Certificate | Or evidence of QMS implementation |
| Technical documentation of the device | Design dossier, risk management, testing records |
| Qualified person details | Technical staff with relevant educational qualifications |
| List of devices to be manufactured with classification evidence | CDSCO product code and risk class reference |
| List of equipment used in manufacturing | Calibration certificates for critical equipment |
| SOPs and batch records samples | Demonstrating GMP compliance |
| Government fee challan | Per MDR 2017 Second Schedule |
Processing Timeline — MD-3 / MD-5 (Class A/B)
| Stage | Timeline |
| Document scrutiny by SLA | 15–30 working days |
| Factory inspection (if required for Class B) | Scheduled within 45 days of application |
| Deficiency response window | 30 days from deficiency letter |
| MD-5 license grant | Within 45–90 days of complete application |
| Validity | 5 years (renewable) |
MD-7 Application and MD-9 Manufacturing License for Class C/D MRI Machines
This is the most comprehensive and stringent license pathway for Indian companies manufacturing full MRI scanner systems — including 1.5T closed-bore MRI, 3.0T systems, or high-field research systems. Form MD-7 is submitted to CDSCO's Central Licencing Authority (CLA) and Form MD-9 is the resultant manufacturing license grant.
Who Needs MD-7 / MD-9?
- Indian companies manufacturing complete 1.5T or 3.0T MRI systems (Class C)
- Manufacturers of 7T or higher ultra-high field MRI systems (Class D)
- Companies manufacturing MRI-guided therapy systems, intraoperative MRI, or MRI-Linac systems (Class D)
- Manufacturers of MRI gradient coil assemblies and RF coil systems classified as Class C
Documents Required for MD-7 / MD-9 Application (Class C/D)
| Document | Requirement |
| Form MD-7 (online SUGAM application) | Filed with CDSCO CLA — mandatory |
| Device Master File (full technical dossier) | Design history file, risk management, performance testing |
| Clinical evaluation report (CER) | Required for Class C/D — literature or clinical trial data |
| Risk management file per ISO 14971 | Complete risk assessment for the MRI system |
| IEC 60601-2-33 test report (from accredited lab) | Specific to MRI safety — SAR limits, RF safety, gradient performance |
| ISO 13485 certificate | QMS certification from accredited body |
| Site Master File | Complete manufacturing, assembly, QC, and service areas |
| GMP compliance report / audit | Pre-licensing factory inspection by CDSCO-authorised officer |
| Electromagnetic compatibility test reports | Per applicable IEC 60601-1-2 standard |
| Software validation documentation (if applicable) | For embedded MRI software / image reconstruction algorithms |
| Post-market surveillance plan | Mandatory for Class C/D |
| Labelling compliance — MDR 2017 Schedule IV | Compliant IFU and labelling proofs |
| Government fee challan — Class C: INR 50,000 / Class D: INR 1,00,000 | Per MDR 2017 Second Schedule (indicative) |
Processing Timeline — MD-7 / MD-9 (Class C/D)
| Stage | Timeline |
| Pre-submission meeting (Class D — recommended) | Before formal filing |
| Document scrutiny — CDSCO CLA | 30–45 working days |
| Manufacturing site GMP inspection | Within 60 days of scrutiny clearance |
| Technical query response period | 30 days per query round |
| MD-9 license grant | 4–9 months from complete application |
| Validity | 5 years (renewable before expiry) |
Why the CDSCO License for MRI Machine Matters: Key Benefits
- Legal Market Access: Without a valid CDSCO license for MRI machine, import, sale, or manufacture is illegal and subject to seizure under Section 26B of the Drugs and Cosmetics Act.
- Hospital & Tender Eligibility: Government hospitals, AIIMS, CGHS-empanelled facilities, and private diagnostics chains require proof of CDSCO registration before procurement.
- Export Readiness: A valid CDSCO license and ISO 13485 certification strengthens the export credentials of Indian MRI device manufacturers for overseas market entry.
- Post-Market Surveillance Compliance: Licensed entities are mandated to report adverse events and conduct product recalls through the SUGAM vigilance module.
- Brand Protection: CDSCO registration proves product authenticity and protects against counterfeit competition in the Indian MRI equipment market.
- Patient Safety Assurance: The licensing framework ensures that only MRI systems meeting IEC 60601-2-33 and relevant IS standards are deployed in clinical settings.
Validity and Renewal of CDSCO MRI Machine Licenses
| License Type | Validity Period | Renewal Timeline | Form for Renewal |
| MD-15 Import License | Lifetime (with conditions) | Review upon product change or complaint | MD-14 (amendment) |
| MD-42 Wholesale License | 5 years | Apply 6 months before expiry | MD-41 (renewal) |
| MD-5 Manufacturing (Class A/B) | 5 years | Apply 3 months before expiry | MD-3 (renewal) |
| MD-9 Manufacturing (Class C/D) | 5 years | Apply 6 months before expiry | MD-7 (renewal) |
Silvereye Certifications tracks all your license renewal dates and proactively initiates filings to prevent lapses that can disrupt your MRI machine supply chain.
Common Challenges in Obtaining CDSCO License for MRI Machine
- Incorrect risk classification: Many applicants misclassify MRI sub-components, leading to rejection or reclassification during scrutiny.
- Incomplete technical dossier: For Class C/D systems, CDSCO expects comprehensive IEC 60601-2-33 test data, clinical evaluation, and risk files — gaps are the top reason for deficiency letters.
- Power of attorney issues: POA documents from overseas manufacturers must be notarised, apostilled, and consularised in some cases — errors here cause significant delays.
- IFU / labelling non-compliance: Labels must carry all MDR 2017 Schedule IV mandatory elements in English. Non-compliance triggers automatic deficiency.
- SUGAM portal technical errors: Incorrect product codes, wrong form selection, or fee challan mismatches are common procedural pitfalls.
- GMP inspection readiness: Many Class C/D manufacturers underestimate the scope of CDSCO factory inspections — inadequate SOPs, records, or qualified personnel cause application failures.
About Silvereye Certifications
Silvereye Certifications is a leading Indian regulatory compliance consultancy with deep expertise in CDSCO medical device licensing, BIS certification, BEE energy efficiency ratings, PESO approvals, FSSAI, and DPIIT/QCO frameworks. Our team of regulatory specialists has successfully completed 500+ CDSCO registrations across medical device classes A through D.
For MRI machine CDSCO licensing, we provide end-to-end services including product classification advisory, technical dossier preparation, SUGAM portal filing, query response management, GMP inspection support, and post-license compliance monitoring.
Our clients include multinational MRI equipment OEMs, Indian medical device manufacturers, hospital procurement teams, and distribution companies across Indi
Frequently Asked Questions
Is it mandatory to have a CDSCO license to import MRI machines in India?
Yes, it is absolutely mandatory. Under MDR 2017, MRI machines are notified medical devices and cannot be imported without a valid Form MD-15 import license. Violation attracts seizure, penalties, and prosecution under the Drugs and Cosmetics Act, 1940.
What is the risk classification of a standard 1.5T MRI machine under MDR 2017?
A standard 1.5T closed-bore MRI system is classified as Class C (moderate-high risk) under MDR 2017. Class D classification applies to 7T and above ultra-high-field systems, intraoperative MRI, and MRI-guided therapy platforms.
Who is the licensing authority for MRI machine import licenses?
The Central Licencing Authority (CLA) at CDSCO, under the Drugs Controller General of India (DCGI), is the authority for Class C and Class D import licenses (MD-15). Class A and Class B import applications are processed through the State Licensing Authorities in most states.
What is the difference between Form MD-14 and Form MD-15?
Form MD-14 is the application form submitted to CDSCO for an import license. Form MD-15 is the license document that CDSCO grants after reviewing the MD-14 application and supporting documents. MD-14 is what you submit; MD-15 is what you receive.
What is the CDSCO license fee for importing a Class C MRI machine?
As per the MDR 2017 Second Schedule, the application fee for Class C devices is INR 15,000 and the license grant fee is INR 10,000. Additional fees may apply for multiple device categories. Always verify the latest fee schedule on the SUGAM portal before filing.
How long does it take to get CDSCO approval for a Class D MRI machine?
Class D MRI machine approvals typically take 6–12 months from the date of complete application submission. The process includes document scrutiny, technical queries, and in some cases, a pre-submission meeting with CDSCO and a factory GMP inspection.
Do MRI coils and accessories need a separate CDSCO license?
Yes. MRI coils (such as head coils, knee coils, body coils) and advanced accessories are classified as separate medical devices under MDR 2017 and require their own import license (MD-15) or manufacturing license (MD-5 or MD-9), depending on classification.
Is a wholesale license (MD-42) required to sell MRI machines to hospitals?
Yes. Any entity distributing or selling MRI machines to end-users — including hospitals, diagnostics centres, and imaging facilities — must hold a valid CDSCO wholesale distribution license (Form MD-42) in addition to the import or manufacturing license.
Can a foreign manufacturer directly apply for a CDSCO MRI license?
No. Foreign manufacturers cannot directly hold a CDSCO import license. They must appoint an Indian Authorised Agent (IAA) who applies on Form MD-14 and holds the MD-15 license on behalf of the foreign principal. The IAA takes on legal responsibility for the product in India.
What international standards apply to MRI machines under CDSCO?
The primary safety standard for MRI machines is IEC 60601-2-33 (Requirements for the Safety of MR Equipment for Medical Diagnosis). Other applicable standards include ISO 13485 (QMS), ISO 14971 (Risk Management), and IEC 60601-1 (General Safety). CDSCO expects test reports from accredited laboratories confirming compliance.
What happens if my CDSCO wholesale license for MRI machines expires?
An expired MD-42 wholesale license means you are legally prohibited from distributing MRI machines until renewal is completed. All distribution activity during the lapse period is a violation of MDR 2017. Silvereye Certifications recommends initiating renewal at least 6 months before the expiry date.
