How to Get AERB License?

JR Compliance is an action-oriented consultancy firm, who believe in providing 100% assistance to our clients by investing our sustain efforts in completing the AERB approval registration process immediately. 

To know more about how to get AERB license, contact us immediately.

What is AERB Approval (Atomic Energy Regulatory Board)?

AERB is the statutory body established on 15th November 1983 by the President of India by utilizing the powers vested under Section 27 of the Atomic Energy Act, 1962. It has been established to conduct regulatory and safety functions.  

Is the AERB certificate mandatory?

The AERB certification is mandatory for manufacturing indigenous medical diagnostic X-ray products and importing machinery with radiation to minimize the radiation effect for safety of humans.

Thus, without an AERB approval, a manufacturer won’t be able to manufacture or import medical diagnostic X-ray products and import machinery comprising radiations in India.

What is the aim of AERB?

The aim of AERB is to use ionizing radiation and nuclear energy in India to prevent health and environmental risk. IN a nutshell, the sole purpose of AERB is to restrict the amound of radiation introducted to the humans.

Consequently, AERB has the decree to administer rules and regulations to make sure radiology safety in India. Also, to ensure industrial safety in the units of the Department of Atomic Energy AERB regulates provisions of the Factory Act, 1948.

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Products That Require AERB Approvals

X-ray Machines (Fixed and Mobile)

Digital Radiography (DR)

Portable X-ray Machines

Dental Orthopantogram (OPG)

Bone Mineral Density

X-ray machines (Fluoroscopy)

Computerized Tomography (CT) Scan


Dental X-ray machines

and more

To manufacture or distribute the equipment in bulk requires the AERB approval as a sanction from the regulatory authority. Further, you need to acquire the type approval by AERB for the equipment comprising the radioactivity more than the exempted limit. 

Additionally, manufacturers of consumer products would only be able to supply or manufacture the products by procuring the AERB certification. Thus, if the manufacturers or suppliers do not acquire the AERB authorization, then they won’t be allowed to manufacture or supply the products in the Indian market. 

Only obtaining an AERB approval is not enough, but the manufacturer also has to keep a tight rein on the contamination. For this, the manufacturer has to decontaminate the premises to the admissible level, so that they can be declared appropriate for any use. 

Accordingly, JR Compliance - Delhi based compliance service provider consist a professional team of consultants that will utilize their skills and experience to provide you the finest assistance by ensuring proper documentation, coordination, follow-ups, etc.

Prerequisite For Supply Authorization of X-ray Equipment 

OEM Authorization

OEM is an acronym of Original Equipment Authorization - it is a certifcate which signifies that auto body shop has been following the established repair parameters. Thus, it is a mandatory requirement for a supplier to obtain an OEC authorization for each equipment meant to be supplied.

Conditions to be Applicable on Supplier Authorization
  • The supplier must supply the equipment which are AERB approved.
  • In regard to diagnostic X-ray equipment, lifetime servicing must be provided.
  • Submission of installation report to the authorized body in a prescribed format.
  • It is the responsibility of Supplier to ensure that customer engaged in purchasing of equipment must possess safety protective devices like protective apron, protective barrier, etc.
  • Must check the customer site layout and shielding adequacy.
  • On customer's end, a supplier must be conduct dismantling and discommissioning of equipment, including informing AERB for further action as prescribed by concerned department.
  • Must follow all the rules and regulations as established by authority.
Radiological Safety Officer (RSO)

A RSO is an inidividual who possess the responsibility to use ionizing radiations for medical procedures within a healthcare facility. Therefore, if a Supplier has an in-house radiating centre, then it is an obligatory requirement to have a RSO.

Requirements For Radiation Testing Facility For Demonstration Type Approval
  • A Test facility must be available.
  • In the area of testing, protective accessories must be used.
  • For the safety, limited must be prescribed radiation workers and other individual working or in the tested area.
  • Radiation symbol must be used to indicate the testing area.
  • Appropriate measures must be taken to around or in tetsing area to prevent contamination.
Requirements of Fulfil Before Obtaining an E-approval/ NOC
  • An approval must be obtained by an authorized supplier.
  • Before marketing an equipment, it must obtained a Type Approval certificate from the concerned authority.
  • An importer of a prototype x-ray equipment must be done by an authorized supplier and after obtaining the NOC from concerned authority.
  • A license and NOC will only be issued if an equipment comply with the established safety parameters.
  • Once the permission is obtained a regular/ rountined import will be done of the type approved equipment of a each consignee.
  • A type approval will be considered invalid if any change is made in equipment's design.
Requirements For Radiation Testing Facility For Demonstration Type Approval
  • A Test facility must be available.
  • In the area of testing, protective accessories must be used.
  • For the safety, limited must be prescribed radiation workers and other individual working or in the tested area.
  • Radiation symbol must be used to indicate the testing area.
  • Appropriate measures must be taken to around or in tetsing area to prevent contamination.
  • Recruited staff must be trained as prescribed by AERB.

Documents Required to Obtain AERB Approval

Address proof of the manufacturing unit.

Information concerning equipment.

Identity proof. 

Employment proof.

Obtain the Quality Assurance of the X-ray equipment.

RSO approval is required to submit by the Interventional radiology and computed tomology users.

Equipment ID. 

Room layout details and shielding requirements.

Replica of valid type approval enclosed with NOC.

Radiation survey reports that you can obtain from the equipment supplier and sanctioned agency. 

AERB logo

How to Get AERB License? | AERB Registration Process

An institute will be registered on the e-LORA (e-Licensing of the Radio Applications) which is an e-governance portal for AERB license procurement. 

Submission of details of the X-ray equipment details, and other information.

After the submission of the required information along with the documents, the application will be submitted. 

NOTE - If the mentioned X-ray equipment already has AERB license, then provide record license details, however, if an equipment does not have appropriate AERB license, then AERB license needs to be obtained.

JR Compliance - Delhi's award winning compliance service provider assure to educate you regarding how to get AERB license before commencing the registration process to ensure transparency and reliability. Moreover, we care for our client, which is why we are equipped with resources and experts to complete AERB registration within your time contraints. 

Our Role in AERB Registration

Our AERB registration consultants will educate you regarding how to get AERB license. 

Our AERB consultants will assist you throughout the process of obtaining AERB approval. 

We will assist you in filling the application to avoid inaccuracy. 

Our AERB registration consultants will help you in the process of documentation.

Our AERB certificate consultants will coordinate with AERB officials directly to ensure proper follow-ups, acknowledgments, etc. 

In case of any query, we will provide you with the best possible solution. 

Conclusion

To culminate, obtaining AERB certification is essential to manufacture or import medical diagnostic X-ray products and other machinery with radiation that could be harmful to the end-users. 

Thus, from the point of view of consumers’ safety, AERB approval holds major importance. However, for a complete understanding , it is essential to know about AERB certificate registration, documents required for registration, and more because obtaining the AERB certificate could be tedious.

However, our expert team has experience of 8+ years working with highly reputed brands such as Milton, Samsung, Newline, etc. Thus, we have proven to be in providing exemplary services by undertaking your concerns into account.

Hence, for expert and professional services, contact us immediately.

Have Questions? We Have Got the Answers

Who has the responsibility to obtain AERB approval and license?

The fundamental purpose to obtain an AERB license is to ensure the safety of the patients, care-takers, and individual in medical staff. Considering the safety, it is the responsibility of people engaged in providing facility to above mentioned individual to obtain AERB license as an evidence that safety standards has been maintained.

What is the validity of the AERB license?

An AERB license is valid for 5 years and after expiration it must be renewed.

Does a licensee needs to submit a periodic test safety reports?

Yes, a licensee needs to submit a periodic test safety reports.

On what basis AERB can terminate its services?

Below-mentioned are some of the reasons based on which AERB can terminate its services -

  • If a supplier decides to cease its functioning.
  • Any contravention made against the safety parameters/ standards established by AERB.
  • Enforcement actions taken by AERB such as issue of enforcement letters or written directives.
  • Suspension or revocation of license.
  • A spot enforcement action taken by authority.
Can I appeal against termination of services by AERB?

Yes, if you disagree with the decision of the AERB authority, you can file an appeal to the Atomic Energy Commission (AEC). 


Disclaimer: All to whom it may concern, JR Compliance is not liable for any direct, indirect, incidental, special, or consequential damages from the use of any information contained on our website, or from any action/ decision taken as a result of using the site.

The information provided on this website is with the sole intention to give information, not a professional opinion. Moreover, our website might include copyrighted material that may or may not have been specifically authorized by the owner, however, used for the purpose of providing information. That constitutes a “fair means” under Section 52 of the Copyright Act, 1957. 


Intellectual Property: This site is our proprietary intellectual property. All the graphics, media, editorial content, and website design (altogether, “content”) used are the intellectual property of JR Compliance which are protected by Trademark, Copyright, and other applicable intellectual property laws.

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