MRI is not a radiation-based modality (no X-rays, no AERB involvement). Instead, it uses strong magnetic fields & radiofrequency waves, so the approvals focus on safety, infrastructure, and patient protection rather than radiation licensing.
📋 Documents & Approvals for MRI Unit in India
🔹 1. Hospital / Business Legal Documents
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Hospital/Diagnostic Center Registration (under Clinical Establishments Act or State Health Authority).
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Trade License, PAN, GST registration.
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Shops & Establishment License (if standalone).
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Fire NOC + Building Safety Certificate.
🔹 2. MRI-Specific Requirements
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Room Layout & Shielding Certificate –
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MRI room must have RF Shielding (Faraday cage).
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Vendor provides an RF Shielding Validation Report.
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Magnet Safety Compliance –
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Quench pipe installation certificate (for helium release in emergencies).
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Vendor’s installation & commissioning certificate.
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AC & Power Load Approval – High electricity load clearance.
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Emergency Backup Power – UPS / Generator compliance.
🔹 3. Safety Compliance
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Bio-Medical Waste Management Authorization – For contrast waste disposal.
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Pollution Control Board Consent – Usually hospital-wide.
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Fire Safety Plan – MRI zones (Zone I–IV) must be included in hospital’s disaster management plan.
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MRI Safety Policy – SOP for screening patients, managing implants, and handling emergencies.
🔹 4. Staff & HR Documents
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Radiologist – MBBS + MD/DNB Radiology (MCI/NMC/State registration).
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MRI Technologist/Radiographer – Degree/Diploma in Radiography with MRI specialization/training.
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Safety Training Records – For all MRI staff (vendor often provides).
🔹 5. Other Operational Records
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Equipment purchase invoice + AMC/CMC agreement.
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Installation & Commissioning Report from vendor.
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Helium refill/maintenance records.
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Emergency quench logs (if any).
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Insurance – Equipment (very costly machine) + liability insurance.
✅ Key Differences – MRI vs CT/X-ray
| Requirement | X-ray | CT Scan | MRI |
|---|---|---|---|
| Regulator | AERB | AERB | No AERB (non-radiation) |
| Radiation Safety | Yes | Yes (strict) | Not needed |
| Shielding | Lead-lined walls | Thick lead shielding | RF Shielding (Faraday cage) |
| RSO | Mandatory | Mandatory | Not needed |
| QA Testing | Yes | Yes (radiation dose + QA) | Yes (vendor QA + magnet safety checks) |
| Staff Training | Radiographer + RSO | Radiographer + RSO | Radiographer with MRI training |
✅ Summary for MRI:
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No AERB license needed.
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Focus is on RF shielding, magnet safety, patient screening, and hospital safety approvals.
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Critical documents: RF Shielding Certificate, Quench pipe compliance, MRI Safety Policy, and trained staff records.
