Atomic Energy Regulatory Board (AERB) Certification

Atomic Energy Regulatory Board (AERB) Certification

Why Choose Us

MetaCorp understands that a business with a global presence is the business that is sought after, that’s why, our professional and experienced team is committed to providing competent, responsive, and excellent compliance services. We are one of the leading compliance service providers in India aware of the know-how of business registration or Indian corporate compliance. Moreover, to allow our clients to reach out to us to avail of our services, we have an integrated approach that allows one-click access. We invest in our people and innovation to create an environment in which people are proud to associate and work with Metacorp.

  • We focus on reducing our customer's compliance costs for positive growth and profitability that help earn our clients' trust.
  • We start the application process as soon as you give us the go-ahead to maintain a vigorous speed all along.
  • Additionally, most of the reputed brands are our customers because we provide premium support by educating our clients regarding each aspect of the certificate, including suggesting the most appropriate approach after adequate research.

It is the responsibility of the Atomic Energy Regulatory Board (AERB) for enforcing the Atomic Energy Act of 1962 rules and regulations in order to ensure radiological protection in the country and also oversee the implementation of the Factories Act of 1948, ensuring industrial protection in the Department of Atomic Energy's units under its jurisdiction. Ensuring the use of ionising radiation and nuclear energy in India does not pose an unacceptable risk to people's health or the environment is the mission of AERB.

It is required to have Type Approval & NOC from AERB if a business entity wants to be registered as a local supplier in the radiotherapy facility. The applicant is also required to share with the AERB details regarding its customers and also ensure that they are registered with AERB.

Documents Required are:

1. Authorization Letter from the Original Equipment Manufacturer (OEM)
2. Details of the tools/equipment used for measurement of radiation, its monitoring & quality assurance
3. Details of the qualified technical person / Radiation Safety Officer (RSO) / Trainee Safety Officer (TSO)
4. Permission to import/ supply radiotherapy equipment
5. Obtain Type Approval from AERB

Any business entity planning to export the prescribed materials, minerals or a plant designed, adopted or manufactured for the production, development and use of atomic energy or for research into matters of atomic energy or any other prescribed equipment/items is required to have this license.

Documents required

1. Complete Filled and signed copy of Import form by the applicant

2. Detailed Company Profile for export of prescribed substance

3. Copy of End User Certificate of foreign buyer/consignee/end user

4. Copy of the Purchase Order

5. AERB NOC if prescribed substance is also radioactive

6. Utilization statement of previous export license issued by AERB

7. Technical details of material annexed along with the application

To apply and get a license from AERB, a business entity must desire to manufacture medical diagnostic X-ray equipment & X-ray tubes. As per the Atomic Energy (Radiation Protection) Rules, 2004, all the entities as the manufacturers/ suppliers/ users of X-ray equipment require Atomic Energy Regulatory Board (AERB) License for carrying out these activities.

Procedure :

1. The first step is to get the permission for procurement/ import of X-ray tubes and X-ray equipment

2. Details of the Radiation testing facility during demonstration of Type Approval

3. Details of the radiation protection devices

4. Details of the quality assurance equipment

5. Details of the qualified person for radiation testing, quality assurance and servicing of diagnostic x-ray equipment

6. Details of each model of X-ray equipment and their AERB approval

7. Details of Radiation Safety Officer (RSO) & his/her comments/recommendations

A business entity that wants to operate or already operating a gamma irradiation chamber facility is required to get this license as per the Atomic Energy (Radiation Protection) Rules, 2004, issued by AERB. 

Documents required

1. Passport size Photograph of Radiation Professional
2. KYC of the Radiation Professional
3. Qualification documents/Certificates/Marksheet of Radiation Professional
4. Final Safety Analysis Report (FSAR)
5. Quality Assurance Manual (QAM) 
6. Radiation Protection Manual (RPM)
 

Industrial Radiography means a non-destructive process for testing materials by using ionizing radiation. The business entity planning to operate or operating radiography devices for industrial radiography facility specified under the Atomic Energy (Radiation Protection) Rules, 2004.

Documents required

1. Passport size Photograph of Radiation Professional
2. KYC of the Radiation Professional
3. Qualification documents/Certificates/Marksheet of Radiation Professional
4. Final Safety Analysis Report (FSAR)
5. Quality Assurance Manual (QAM) 
6. Radiation Protection Manual (RPM)
 

The Atomic Energy (Radiation Protection) Rules, 2004 delineate the rules & regulations for the safe handling of radiation-generating equipment or X-ray equipment). Each manufacturer/ supplier/ user of x-ray equipment is required to get this license, as per rule 3 of The Atomic Energy (Radiation Protection) Rules, 2004.  

Documents required 

1. AERB authorized / Type Approved X-ray equipment from AERB registered suppliers 
2. The AERB NOC for new equipment or declares equipment if existing equipment is being used 
3. Qualified persons’ details  
4. Approval from the RSO 
5. The detailed list of other mandatory instruments 
6. Site Plan / layout of the facility 

The process of using radio-pharmaceuticals, as specialty medicine, to investigate the ailments of human anatomy, physiology & pathophysiology to diagnose & treat the diseases which are plaguing humans.
To get the Atomic Energy Regulatory Board (AERB) Certificate, any individual or a business entity/Health care must establish a plan to operate any nuclear medicine equipment such as PET, PET-CT, Gamma Camera, or SPECT for the diagnosis & treatment of their patients.

Introduction

 

Atomic Energy Regulatory Board (AERB) Certification has developed an electronic licensing system for radiation applications called E-LORA for helping users to file applications and associated documents online. There are guidelines available in this system for all types of facilities and activities involving radiation applications and corresponding requirements. The essential purpose of the Atomic Energy Regulatory Board (AERB) Certification, is to ensure the utilization of radiation and nuclear energy for ionizing in India is not hampering the health of the citizens or the environment.

The Atomic Energy Regulatory Board (AERB) was constituted on 15 November 1983 by the President of India by exercising the powers conferred by Section 27 of the Atomic Energy Act, 1962 (33 of 1962) to carry out certain regulatory and safety functions under the Act. The regulatory authority of AERB is derived from the rules and notifications promulgated under the Atomic Energy Act, 1962, and the Environmental (Protection) Act, 1986. The headquarters is in Mumbai. The mission of the Board is to ensure that the use of ionizing radiation and nuclear energy in India does not cause undue risk to health and the environment. Currently, the Board consists of a full-time Chairman, an ex officio Member, three part-time Members, and a Secretary.

Document Required for the Permission Atomic Energy Regulatory Board (AERB) Certification/Registration

  • Institute Name and Type
  • Registered with any Government Authority
  • Certificate No: If Sr. no. 3 is ‘YES”, fill in the certificate no. of registration
  • PAN
  • TAN
  • Address of Institution
  • Address of Communication
  • Contact Details of your institute
  • Type of Facility
  • Type of Equipment
  • Equipment Installation Report
  • Employee Details who is going to handle the equipment
  • RSO ( Radiological safety officer): Degree/ Diploma in Electrical /Electronic /Biomedical /Mechanical Engineering or in an associated discipline/Basic degree in Science with Physics as one of the subjects from a recognized University/Institution, and 2. Certification of successful completion of the training course on “Radiation Safety and Quality Assurance in Diagnostic Radiology” conducted by authorized agencies, and 3. A certification from the competent authority.
  • Service Engineer: Degree/ Diploma in Electrical /Electronic /Biomedical /Mechanical engineering or in an associated discipline/Basic degree in Science with Physics as one of the subjects from a recognized University/Institution, and 2. Certification of successful completion of the training course on “Radiation Safety and Quality Assurance in Diagnostic Radiology” conducted by authorized agencies.

Acts and Regulations Enacted for Atomic Energy Regulatory Board (AERB) Compliance

Specific Acts were necessary to be enacted for concerns with regard to the establishing and utilizing of any nuclear facilities along with the utilization of radioactive resources that are conducted anywhere across India that fall under the Atomic Energy Act, 1962. Concerns in relation to securing the environment are governed under the Environmental Protection Act, 1986.

Specific Regulations were necessary to be enacted for concerns with regard to radiation protection that is governed under Radiation Protection Rules, 1962, concerns with regard to mining and milling of authorized substances that are regulated under the Atomic Energy Mines Minerals Prescribed Substance Rules, 1984, disposal of nuclear or radioactive waste securely that is governed under the Atomic Energy Safe Disposal of Radioactive Waste Rules, 1987.

Various Acts and Regulations enacted in India govern and grant authorization for the smooth functioning of Atomic Energy Regulatory Board (AERB) Compliance. The applicable acts and regulations for AERB are listed as follows- 

Acts:

  1. The Atomic Energy Act, 1962
  2. The Amendments of the Atomic Energy Act, 2015
  3. The Environmental Protection Act, 1986
  4. The Civil Liability for Nuclear Damage Act, 2010

Regulations:

  1. The Atomic Energy Mines Minerals Prescribed Substance Rules, 1984
  2. The Atomic Energy Safe Disposal of Radioactive Waste Rules, 1987
  3. The Atomic Energy Factories Rule, 1996
  4. The Atomic Energy Radiation Protection Rules, 2004
  5. The Civil Liability for Nuclear Damage Rules, 2011

The Regulatory Procedure of Atomic Energy Regulatory Board (AERB) Approval

As mentioned in the name, Atomic Energy Regulatory Board, also known as the AERB, is a regulatory board established for the purpose of governance over Nuclear Facilities, Radiation Facilities, and Activities, along with ensuring that the ionizing of the Radioactive Nuclear Energy-Based Substances or Radiation of any Radioactive Substances in India is not hampering the health of the citizens or the environment.

AERB is also responsible for regulation over the administration procedure of the industrial safety measures of DAE Units.

The AERB also accepts feedback from National and International Resources and implements changes if necessary. The Chairman of the AERB has the sole authorization to enforce necessary requirements of the new or amended relevant rules and regulations.

The AERB utilizes multiple regulatory procedures for discharging effective responsibilities that ensure the utilization of the Graded Approach. The essential procedures are stated as follows–

  • Developing safety measures and regulations for the users and the applicable utilities.
  • Regulation of the Licensing Procedure for multiple applicable facilities and activities that are in accordance with the safety requirements.
  • The Regulation over Inspections for Compliance Checks per the conditions of the applicable license and the maintenance of the required safety measures.

Functions of Atomic Energy Regulatory Board (AERB) Certification

  • Develop safety policies in nuclear, radiation, and industrial safety areas for facilities under its purview.
  • Develop Safety Codes, Guides, and Standards for siting, design, construction, commissioning, operation, and decommissioning of different types of nuclear and radiation facilities.
  • Grant consents for siting, construction, commissioning, operation, and decommissioning, after an appropriate safety review and assessment, for the establishment of nuclear and radiation facilities.
  • Ensure compliance with the regulatory requirements prescribed by AERB during all stages of consenting through a system of review and assessment, regulatory inspection, and enforcement.
  • Prescribe the acceptance limits of radiation exposure to occupational workers and members of the public and acceptable limits for environmental releases of radioactive substances.
  • Review the emergency preparedness plans for nuclear and radiation facilities and during the transport of large radioactive sources, irradiated fuel, and fissile material.
  • Review the training program, qualifications, and licensing policies for personnel of nuclear and radiation facilities and prescribe the syllabi for the training of personnel in safety aspects at all levels.
  • Take such steps as necessary to keep the public informed on major issues of radiological safety significance.
  • Maintain liaison with statutory bodies in the country as well as abroad regarding safety matters.
  • Promote research and development efforts in the areas of safety.
  • Review the nuclear and industrial safety aspects in nuclear facilities under its purview.
  • Review the safety-related nuclear security aspects in nuclear facilities under its purview.
  • Notifying the public, of the 'nuclear incident', occurring in the nuclear installations in India, as mandated by the Civil Liability for Nuclear Damage Act, 2010.

About Us: 

Having 7+ years of experience, MetaCorp has been providing 360-degree compliance services to startups, firms, and establishments with the motive to make compliance services unchallenging for everyone. Be it BIS, BEE, AERB, or FSSAI, including MSME Registration, CDSCO Registration, and any other corporate compliance service and business registration, we are equipped with all the resources and experts to provide reliable and competent compliance services, including global services. That’s why we will be responsible for following the systematic registration process, including filing the registration form, documentation, testing (if required), inspection (if required), and coordinating with the authorities for proper follow-up and acknowledgment - we have got everything covered. Our mantra is to provide technical compliance certifications with click access at a reasonable cost.

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