The Atomic Energy Regulatory Board (AERB) is the national regulator for radiation safety in India, established under the Atomic Energy Act, 1962. AERB regulates every source of ionising radiation used in medicine, industry, research and consumer products — medical X-ray machines, CT scanners, PET-CT machines, mammography units, dental X-rays, industrial radiography devices, gamma-radiation gauges, security scanners at airports, and even luminous exit signs. Anyone importing, manufacturing, installing, using or decommissioning such equipment in India needs AERB approval — typically through Type Approval for the equipment model and a separate Licence for the facility using it.
The Exim Roof runs an AERB practice that has taken hospitals, imaging centres, industrial-radiography firms and equipment importers through the eLORA (e-Licensing of Radiation Applications) portal since 2014. From Type Approval of new X-ray machines through Layout Approval of imaging suites, Radiation Safety Officer (RSO) appointment and licence renewals, we take end-to-end ownership.
AERB approvals — the full stack
- Type Approval — model-wise approval of the radiation-generating equipment. Required before import or sale.
- Import Licence — permission to import a specific quantity of Type-Approved equipment.
- Layout Approval — approval of the room / suite layout to ensure radiation shielding is adequate.
- Institutional Registration — registration of the facility that will use the equipment.
- Licence for Operation — permission to actually operate the equipment.
- RSO (Radiation Safety Officer) approval — mandatory qualified personnel to oversee radiation safety.
- Decommissioning — permission to safely decommission and dispose of the equipment / source.
Regulatory framework
AERB approvals are administered under the Atomic Energy (Radiation Protection) Rules, 2004 and the various Safety Codes issued by AERB — including AERB/SC/MED-2, MED-4 and MED-5 for medical diagnostic X-ray, radiotherapy and nuclear medicine equipment. Applications are filed on the eLORA portal and go through a technical-safety review by AERB officers.
The Type Approval process
Stage one is manufacturer authorisation — the applicant (typically an Indian distributor or subsidiary) must hold formal authorisation from the equipment manufacturer. Stage two is technical documentation — datasheet, radiation-output specifications, tube type, filtration, generator specifications, safety-interlock design, mAs / kV range and cabinet design. Stage three is application filing on eLORA with fee payment. Stage four is AERB technical review. Stage five is grant of Type Approval, valid for the life of the model unless withdrawn.
Layout Approval and Facility Licence
A hospital or imaging centre installing an X-ray or CT machine must obtain Layout Approval based on architectural drawings showing walls, doors, viewing windows and shielding materials (lead thickness). AERB reviews the drawings against the Safety Code and either approves or asks for design modifications. Once the equipment is installed and commissioning tests are complete, the facility applies for the Licence for Operation with the RSO details and radiation-monitoring plan.
How The Exim Roof helps
- Type Approval application for imported / manufactured radiation-generating equipment.
- Import Licence for each shipment.
- Layout Approval with shielding design and drawing preparation.
- Institutional Registration and Licence for Operation.
- RSO shortlisting and approval application.
- Renewals and decommissioning support for the life of the equipment.
AERB Certification Process — Step by Step
- 1
Step 1: Free Consultation
A no-obligation 20-minute call to understand your product, project, market and the exact approvals you need.
- 2
Step 2: Document Preparation
Our specialists prepare, review and vet every document so your application clears the portal in the first submission.
- 3
Step 3: Portal Filing & Fee Payment
We handle the online application, government fee payment and coordinate with test labs / auditors where required.
- 4
Step 4: Department Liaison
Continuous follow-up with the concerned authority, response to queries and any additional information sought.
- 5
Step 5: Certificate / Approval Grant
Once approved, the certificate is delivered to you along with a compliance calendar for renewals and returns.
Documents Required for AERB Certification
- PAN of the applicant / company
- GST registration certificate
- Certificate of Incorporation / partnership deed
- Product details, technical write-up or project report
- Authorised signatory ID proof (Aadhaar / passport)
- Address proof of manufacturing unit or office
- Equipment datasheet, radiation-output specification and safety-interlock design
- Manufacturer authorisation letter for the applicant
- Facility layout with shielding calculation
- Radiation Safety Officer qualification and approval status
- Room-plan drawings and material specifications
Why Choose The Exim Roof for AERB Certification
- Type approval
- Import license
- Facility layout review
Frequently Asked Questions
- How long does the entire process take?
Most approvals are granted in 30–90 days once documentation is in order. Timelines vary by department, product category and testing requirements — we share a milestone-based plan on day one.
- Do you handle end-to-end filing?
Yes. Our team drafts the application, uploads it on the government portal, pays the fee (against invoice), coordinates with labs / auditors and follows up till the certificate is granted.
- Will you help with renewals and post-approval compliance?
Absolutely. We share a compliance calendar with due dates for renewals, annual returns and periodic filings. You will never miss a deadline.
- Can I use imported X-ray equipment without AERB Type Approval?
No. Any radiation-generating equipment used in India must be Type-Approved by AERB. Customs will not clear the consignment without an AERB import licence, and the facility cannot lawfully operate the equipment without a Licence for Operation.
- Who can act as a Radiation Safety Officer?
An RSO must hold the appropriate qualification (typically a graduate degree in physics or radiography) and must have completed the AERB RSO-certification course for the applicable category (diagnostic radiology, radiotherapy, industrial radiography, etc.).
- How long is an AERB licence valid?
Type Approval is granted for the life of the equipment model. Licence for Operation is typically granted for five years and renewable, subject to satisfactory radiation-safety records and RSO continuity.
Need more information about AERB Certification?
Fill in the form below and our compliance team will get back to you within one business day.
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