The government constituted the Atomic Energy Regulatory Board (AERB) to regulate the use of nuclear energy and ionizing radiation as these elements pose undue and serious risks to the public health and environment. All the nuclear and radiation-generating facilities and equipment are, therefore, regulated by the AERB Registration.
Who Shall Obtain AERB License?
The AERB license is mandatory for the following:
- Institutes having medical diagnostic X-ray equipment, X-ray lights and fluorescence scanners etc. shall obtain AERB registration
- Manufacturers and suppliers of the devices and Equipments that use ionizing radiation shall have design and type approval
- Manufacturers and suppliers of the consumer products that use the ionizing radiation should obtain AERB license
- Radiation devices like X-ray machines, fluorescence scanners and X-ray lights
One of the significant requirements of AERB registration stems from the case of medical devices and equipment. Apart from these, even the nuclear plants, radiation facilities, neutron generators etc. are required to possess AERB registration for functioning. It can be said that any facility that deals with the radiation and radioactive materials shall obtain AERB registration.
AERB Registration Process
AERB license registration process is comprehensive and requires detailed information relating to the project, equipment and applicant. Here’s the detailed AERB registration process for medical devices:
- Firstly, you need to obtain procurement permission for the medical equipment from AERB
- An installation report from the e-LORA portal shall be submitted regarding the operation of the X-ray equipment
- Open the E - LORA portal
- You need to register as the employer of the project
- You will receive the login credentials on your registered email ID and mobile number
- Fill in all the relevant details of the project in the registration application form for the operation of the project. This includes the following:
- Project name
- Project type
- Registration details of the government department
- Comprehensive details about the X-ray equipment
- Address of the project
- Project certificate number
- Project facility type
- Any other information as may be required
Once the AERB application form is submitted, the authorities will scrutinize the application and if found satisfactory, then the license shall be issued within 120 days.
Documents Required for AERB Registration in India
You need to submit the following documents along with the filing of AERB registration:
- KYC documents
- Address proof, including that of the manufacturing unit
- Certificate of incorporation or registration
- Details regarding the equipment
- Equipment ID
- Equipment quality assurance
- RSO approval, in the case of computed interventional radiology and computed technology users
- Radiation survey reports from the sanctioned agency and equipment supplier
- Valid type approval along with the NOC
- Any other document as may be required
X-Ray Equipment & Devices: Authorization for Supply
In case you are engaged in the supply of X-ray equipment, then you shall satisfy the following conditions:
- OEM Authorization: You need to obtain the OEM authorization for all the equipment you are planning to supply.
- Radiation Testing Facility
- There should be a testing facility other than in the work area not related to radiating or testing.
- Limits should be specified for the radiation workers. Further, there should be limited public in that area.
- Protective accessories shall be provided in the testing area.
- The radiation symbol should be placed in all the areas where radiation activity takes place. Safety measures should be taken to avoid contamination of the area.
- Staffing: You shall recruit qualified staff for the purposes of QA, testing and servicing of X-ray machines. AERB authority shall specify the qualification requirements and training.
- Radiological Safety Officer (RSO): A Radiological Safety Officer (RSO) should be employed if the supplier has an in-house radiating facility. The officer should be employed with the regulatory body’s approval.
- Conditions for Authorization of Suppliers
- The supplier shall supply the models approved by AERB
- For diagnostic X-ray equipment, lifetime servicing should be provided
- It should be ensured that the customer purchasing the equipment possesses the safety protective Equipments and gears like a protective apron, protective barriers, rubber flaps etc.
- Check for the shielding accuracy and layout at the customer site
- Submit the installation report in the prescribed format to the regulatory body
- Carry out the decommissioning and dismantling of the equipment at the customer end and inform the AERB of any further action if required
- Any other condition that shall be fulfilled
- No Objection Certificate (NOC) / E-Approval
- Authorized suppliers shall take the necessary e-approval or no-objection certificate
- In the case of imported equipment, the supplier shall obtain a Type Approval Certificate from the concerned authority before marketing the X-ray equipment. The approval is based on the performance of the X-ray equipment prototype
- Import of the X-ray equipment prototype required for Type Approval should be undertaken by the supplier after NOC for import has been obtained from the concerned authority
- NOC or type approval shall be issued only if the equipment fulfills the applicable standards and safety requirements
- After the type approval for X-ray equipment is obtained, importers can make routine imports of the type-approved models after obtaining permission for procurement from the relevant authority for each consignment
- If there is any change in the design of the model for which Type Approval has been obtained, then the type approval becomes invalid
- Safety Reports: The license holder shall submit safety status reports periodically to the authorized body in the specified format
Registration Under AERB
- Register as an Institute
- Log in to the e-LORA portal
- Click on ‘Register Institute’ and fill out the application form
- Enter the relevant details in the tab of ‘Institute Details’. This includes proof of registration with the central government and numbered certificate obtained from the registrar stating the authority under the central government under which the unit was established
- PAN and TAN details
- Select the ‘Diagnostic Radiology’ option as the type of facility and ‘Medical Diagnostic X-ray facility’ as the role of the institute
Once all the details are submitted, the employer shall receive the login details that can be used to complete the AERB registration process. In case the hospital is already registered as a radiotherapy or nuclear medicine facility, then it only needs to add diagnostic radiology to its existing registration.
- Registration as RP
- Log in to the e-LORA portal
- Click on ‘Register RP’ and ‘Personal Details
- Select Diagnostic Radiology as your practice and Radiation Safety Professional as your professional role
- Furnish the educational details of the RP and provide the necessary attachments
- Once the application is approved, then an RP ID shall be issued
How Exim Advisory Can Help?
AERB was formed considering the sensitivity and hazardous potentials of the radiation equipment. The AERB registration is granted only after careful verification of the AERB registration application and after approval of the equipment. Here’s how the Exim Advisory can help in this regard:
- Gathering of all the documents and information required for AERB registration
- Preparation and filing of the application for AERB registration
- Assistance in obtaining necessary approvals required for AERB registration like Type Approval etc.
- Helping you in satisfying all the prerequisites and conditions necessary for approval of AERB registration
- Liaising with the AERB authorities for resolution of the queries and objections
- Ensuring timely and accurate post-registration compliances
- Ensuring timely renewal of AERB registration
Also, Check "Licenses Required to Start an Import Export Business in India"
Frequently Asked Questions
Q: What is the validity of AERB registration?
A: The AERB registration is valid for a period of 5 years following which it shall be renewed.
Q: Is AERB registration mandatory?
A: AERB license is mandatory in case you are dealing with radiation devices
Q: What are the AERB guidelines for safety review?
A: AERB conducts a comprehensive safety review of all the nuclear plants every 5 years, usually at the time of renewal. Further, detailed and comprehensive Periodic Safety Reviews (PSR) are conducted by the AERB every 10 years.
Q: What are the examples of X-ray equipment that needs AERB approval?
A: The following are some of the common examples of X-ray equipment that needs AERB approval:
- Mammography machines
- Computed Tomography Machines
- Cath Lab Equipments
- Radiography Machines