Introduction:
The Atomic Energy Regulatory Board in India is essential to guaranteeing the safe use of nuclear energy and ionising radiation, safeguarding the environment, workers, and general public. AERB registration and license are essential for every organisation that uses radioactive materials or radiation-emitting equipment. It is impossible to overestimate the significance of AERB registration in India, since it guarantees adherence to strict safety guidelines and standards, averting possible risks related to radiation exposure. Understanding and following AERB laws is essential for both operational safety and legal compliance, regardless of whether one is a member of a medical facility, industrial unit, or research institution.
Importance of AERB Registration:
In India, registering with the AERB is crucial. In order to protect people, the general public, and the environment, the Atomic Energy Regulatory Board (AERB) is the highest body tasked with regulating the prudent use of nuclear energy and ionising radiation.
Registration with the AERB is required for anyone engaged in operations involving radioactive materials or radiation-emitting devices. This covers any organisation that works with radioactive materials, including hospitals, factories, research centres, and other establishments. Organisations reduce the danger of radiation hazards, which can have detrimental effects on human health and the environment, by making sure that AERB requirements are followed.
These organisations are guaranteed to follow strict safety regulations, put in place the required safeguards, and be subject to frequent AERB inspections and audits when properly registered and licensed. Proper license and registration are necessary to accomplish this. This encourages a safety-conscious culture and builds public trust in the responsible handling of radioactive materials.
Therefore, obtaining and preserving AERB registration is crucial for operational security, regulatory compliance, and the protection of all stakeholders engaged in the use of nuclear energy and ionising radiation.
AERB-regulated X-ray-based equipment
The human body can tolerate very low radiation exposure levels without suffering any negative effects. Therefore, X-ray equipment is employed since it is more useful for diagnosing disorders that can be treated with less radiation and for other use as well. Disease diagnosis can be aided by controlled amounts of X-ray radiation. On the other hand, significant cumulative radiation exposure over brief periods of time and negligent exposure can be extremely detrimental to health. For this reason, AERB controls how radiology equipment is used.
Further, the AERB regulation also governs several other consumer goods and scanning services, such as:
- Type Approval equipment: X-ray Inspection System, Food scanners, X-ray Diffractometer, X-ray Fluorescence Device (both cabinet type & hand held), PCB analyzers.
- Type Registration equipment’s: Ionization Chamber smoke detector, Electron Capture Detector, Ion mobility spectrometer, suspended particulate matter detector and Tritium Based devices.
Once equipment is identified, it must undergo a registration process, which is further categorized into Source Type Approval or Source Type Registration based on its origin and intended use. If the equipment involves radioactive sources that are manufactured within India, it falls under Source Type Approval. In the case of imported radioactive sources, Source Type Registration is required.
Additionally, Option Type Registration applies to sources utilized in consumer products and scanning facilities. Upon selecting the appropriate registration category based on the nature of the application, the relevant form must be completed with the necessary details in accordance with the specified requirements.
- Sealed Source Compliance Certificate – Certification confirming compliance with relevant standards.
- Applicable Standards – Specify national/international standards the source adheres to.
- Performance Verification Report – Test certificate/report from an accredited laboratory or approved agency.
- Source Details Document – Includes:(Maximum design activity, External & active dimensions, Encapsulation material & melting point, Dose rate at reference distance, Physical & chemical form, Maximum stray radiation level at 10 cm, Leak test report, Accident condition data (fire temperature & duration)
- Approval Certificate – Certification from the competent authority of the country of origin, if applicable.
Process to obtain NOC/Type Approval (TA) consumer products and scanning facilities
Equipment Type Approval/ NOC:
For foreign make equipment, all suppliers are required to obtain type approval through the following path: Regulatory Forms >> Consumer Products and Scanning Facility >> Equipment Type Approval/Type Registration/NOC (Note: Without a valid TA, the end user cannot select the equipment in e-LORA.)
Step-1: NOC (No Objection Certificate, applicable only for imported Consumer product equipment): This form is applicable for imported equipment (foreign make).
The form for obtaining the NoC is accompanied by the following documents:
- National/International Standards to which the equipment conforms (Certificate of conformity for the device, including X-ray tube, generator, and monoblock – English version of CE/FDA Certificate or equivalent, preferably issued by a notified/certified body).
- Product technical details (Technical catalogue and manual of equipment as a whole).
- Operation Manual.
- Radiation Leakage Test Report.
- OEM Authorization for the supply of Equipment.
- Technical reference table for the evaluation of NOC/Type Approval Application of self-shielded X-ray-based equipment..
Step-2: Conversion of NOC to TA: Indian suppliers must apply for conversion of NOC to TA after obtaining NOC.
e-LORA: Streamlining the Licensing Procedure
To assist users in submitting applications and related papers online, AERB has created e-LORA, an electronic web-based application licensing system for radiation applications. This system contains recommendations for all kinds of facilities and activities that include radiation applications and the requirements that go along with them. This online system covers both diagnostic (such as X-ray machines, CT scanners, cath lab equipment, C-Arms, mammography machines, general purpose industrial radiography machines, etc.) and therapeutic (such as radiotherapy, nuclear medicine, and RIA) uses of radiation. All manufacturers, suppliers, service agencies, X-ray facilities, and other interested parties, such as radiologists, radiographers, technicians, etc., must use e-LORA to get the necessary consents from AERB. The e-LORA portal has comprehensive guidelines for all parties involved.
Online Registration Procedure:
The AERB launched e-LORA, an e-governance tool, to expedite the licensing procedure. It is mandatory for all X-ray equipment users to register via the e-LORA system. The user needs to follow the following process:
Register your Company/institute with e-LORA at www.aerb.gov.in.
Company/Institute Details: Complete All Fields: Fill in all required information, noting that fields marked with an asterisk (*) are mandatory and ensure that the entered data matches the attached certificates.
Facility Information: In the ‘Type of Facility’ section, select ‘Diagnostic Radiology’ under the ‘Practice’ field and Select ‘Medical Diagnostic X-ray Facility’ under the ‘Role of Institute’ field.
Employer Details
- Name: Enter the full name as it appears on the attached proof of identity and date of birth (DOB).
- Date of Birth: Enter the DOB exactly as it appears on the proof of identity and DOB.
- Document/Card Number: Ensure the number matches the proof of identity and DOB provided.
- Email: Provide a suitable email address for receiving user ID, password, and future communications.
- Mobile Number: Provide a mobile number for receiving SMS alerts.
Attachments
- Mandatory Attachments: Upload proof of identity and date of birth and Upload proof of employment.
- Optional/Context-Based Attachments: Upload additional supporting documents such as PAN card, TAN card, Aadhar card, driving license, or passport, if applicable.
- Submit Details: Review and submit all entered information and attachments.
A notification with the application reference number will be sent to the user upon successful submission. You can get a copy of the application that was submitted. Additionally, the registered email address will receive an email with this information. For your records, it is best to have a printed copy of your application.
NOTE: The user will receive their login credentials in their registered email address once their institute registration has been approved. Please ensure that you input the right email address.
Permission to use the current x-ray machines in e-LORA: The following requirements must be met to receive a license:
- The availability of radiation workers with the necessary qualifications.
- The availability of the required safety equipment, such as protective aprons and barriers.
- Details of the layout and shielding (per AERB criteria).
- Report on the Quality Assurance test.
- Radiation Safety Officer (RSO) with approval.
QA: To report the findings of QA tests
Every X-ray equipment should be put through Quality Assurance (QA) testing, and a signed and stamped QA report in the appropriate format should be kept on file. If required, provide the test results in your application.
The primary goal of quality assurance for an X-ray equipment is to guarantee that the best possible image quality for radiological treatments is obtained while exposing with the human body the least amount of radiation. An accurate diagnosis requires a high-quality image, but not at the expense of overexposing the human body to x-ray radiation. Even if the equipment is the best and was operating smoothly when it was installed, it may not be operating at its best if it has not undergone periodic quality assurance. Due to incorrect settings or repeated exposure, the technician may wind up overexposing the patient to produce a high-quality image.
Further, all X-ray equipment must undergo quality assurance (QA) every two years.
RSO clearance
Before applying for a license to operate through e-LORA, users of Computed Tomography and Interventional Radiology must have clearance from a Radiation Safety Officer (RSO).
Radiation Survey Report
Obtain a radiation assessment in the format specified by the equipment maker or approved organisations, and include the pertinent data in the application (if applicable).
Conclusion:
In conclusion, securing AERB registration via e-LORA ensures compliance with India’s radiation safety standards. Operational safety and regulatory compliance are promoted by this expedited procedure, which ensures safe handling of radiation equipment across sectors from initial registration to QA testing.
Contact our knowledgeable regulatory compliance team at compliance@khuranaandkhurana.com and corporate.law@khuranaandkhurana.com for expert help obtaining AERB NOC and licenses for a smooth process!