Regulatory Services

AERB Approval for Medical Devices

Expert Support for Radiation Device Compliance and Regulatory Approval in India

What is AERB Approval?

If your medical device involves ionizing radiation, such as X-ray machines, CT scanners, linear accelerators, or nuclear medicine equipment, you must obtain mandatory AERB approval before import, manufacture, sale, installation, or use in India.

The Atomic Energy Regulatory Board (AERB) governs radiation safety under the Atomic Energy Act, 1962, ensuring protection of patients, workers, and the public from radiation hazards.

We specialize in guiding manufacturers, distributors, hospitals, and diagnostic centres through every stage of the AERB approval process for radiation-emitting medical devices.

We provide end-to-end support for AERB compliance tailored to your device class, usage setting, and regulatory needs:

Device Classification & Applicability Assessment

  • Determine if your device falls under AERB regulatory scope
  • Identify applicable safety codes, notifications, and license requirements

AERB Registration & Licensing Support

  • e-LORA registration and application submission
  • Obtain approvals for:
    • Type approval for new radiation equipment
    • Institution license to possess/use radiation devices
    • Import and installation clearance
    • Site approval and layout review

Technical Documentation & Safety Reports

  • Radiation shielding calculations and facility layout drawings
  • Quality assurance (QA) and performance testing protocols
  • Radiation safety officer (RSO) appointment and training coordination

Post-Approval Compliance

  • Support with annual QA tests, equipment relocation, or decommissioning
  • Renewal of AERB licenses and reporting assistance
  • Audit readiness for AERB inspections

Who Needs AERB Approval?

Contract Manufacturers & Suppliers

Medical Device Manufacturers (X-ray, mammography, CT, LINACs, etc.)

Medical Device & IVD Manufacturers

Importers & Distributors of radiation equipment

Distributors & Importers

Hospitals, Clinics, Imaging Centers, and Dental Setups

EU Authorized Representatives

Service Providers involved in installation, maintenance, or calibration

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