Navigating AERB Regulations for MRI Systems
While MRI systems do not use ionizing radiation and are not directly regulated by AERB (Atomic Energy Regulatory Board) like CT or X-ray equipment, medical imaging facilities in India must still comply with various regulatory requirements. This guide clarifies the compliance landscape for MRI installations in 2026.
MRI Safety vs. Radiation Safety
Important distinction: AERB primarily regulates ionizing radiation sources. MRI uses magnetic fields and radio waves. However, most hospitals operate multiple modalities, so understanding the broader regulatory framework is essential.
Key Regulatory Requirements
1. For the MRI System Itself:
- Import License: Required from DGFT for imported equipment
- CDSCO Registration: Medical device registration (if applicable)
- Bureau of Indian Standards: Compliance with IS standards for medical equipment
- State Pollution Control Board: NOC for chiller and cooling systems
2. For Your Facility:
- Building Approval: Structural certification for magnet room floor loading
- Fire NOC: Updated fire safety certificate
- Electrical Safety: Certification from licensed electrical contractor
- Clinical Establishment Registration: State-specific requirements
e-LORA Registration (for facilities with CT/X-ray)
If your facility also operates CT scanners or X-ray equipment, you must register on AERB's e-LORA (e-Licensing of Radiation Applications) portal. While MRI doesn't require AERB license, your facility's overall radiation safety program should be documented.
MRI-Specific Safety Documentation
- Zone Implementation: Document 4-zone safety system (Zones I-IV)
- Safety Committee: Constitute MRI Safety Officer and committee
- Screening Protocols: Written policies for ferromagnetic screening
- Emergency Procedures: Quench protocols, evacuation plans
- Training Records: Staff MRI safety training documentation
Timeline for Approvals
| Approval Type | Typical Timeline |
|---|---|
| Import License (DGFT) | 2-4 weeks |
| Building Structural Approval | 1-2 weeks |
| State Clinical Establishment | 2-4 weeks |
| Electrical Certification | 1 week |
Sunrays Support
Sunrays Image Technology provides complete documentation support for MRI installations. Our team helps you navigate regulatory requirements and prepares all necessary filings.
Fact-Checked by Ravi Rulania, CEO, Sunrays Medical
