It is statutory requirement for the indigenous manufacturer of medical diagnostic x-ray equipment and x-ray tubes to obtain a-priori Licence for commercial production from the competent authority as per Atomic Energy (Radiation Protection) Rules 2004.

The manufacturer shall obtain import permission for x-ray tubes and x-ray tube inserts. He shall maintain data of testing of x-ray tubes and equipment.

Indigenous manufacturer of x-ray equipment shall also obtain Type Approval certificate from the competent authority for the prototype of every model of x-ray equipment before manufacturing on commercial scale.

Pre-requisites to obtain Licence for commercial production of X-Ray Equipment and X-ray Tubes

• Radiation testing facility:

  A dedicated testing facility shall be available, located away from other working areas not related to radiation testing. The shielding and space requirements to the testing facility shall be such that the dose limits for radiation workers and public, as prescribed by competent authority are met with. The facility shall be equipped with required protective accessories. A warning placard shall be displayed outside the testing facility. (please see layout guidelines for details)

• Quality Assurance test tools:

  All the prescribed quality assurance test tools shall be available for testing. Any such test tool used to perform checks needs to have a calibration traceable to an acceptable national or international standard.

• Staff requirements:

  Manufacturers shall have qualified and trained service engineers for radiation testing and Quality Assurance of diagnostic x-ray equipment. The minimum qualifications for service engineers shall be as prescribed by the competent authority from time to time.

• Radiological Safety Officer (RSO):

  Every manufacturer shall have a Radiological Safety Officer (RSO) having qualifications as prescribed and approved by the competent authority from time to time.

Minimum Qualifications and Experience required for personnel is as follows:

• 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 subject from a recognized University/Institution, and
• Certification of successful completion of training course on “Radiation Safety and Quality Assurance in Diagnostic Radiology” conducted by authorized agencies.
• Radiological Safety Officer(RSO)
• Degree/ Diploma in Electrical /Electronic /Biomedical /Mechanical Engineering or in an associated discipline/Basic degree in Science with Physics as one of the subject from a recognized University/Institution, and
• Certification of successful completion of training course on “Radiation Safety and Quality Assurance in Diagnostic Radiology” conducted by authorized agencies, and
• A certification from the competent authority

Renewal of License:

The Licence shall be renewed before expiry in the format specified by the regulatory body.

Decommissioning of the facility:

The licensee shall obtain the requisite consent for decommissioning of the facility. All authorized supplier shall be intimated six months in advance prior to actual decommissioning.

Terms and Conditions of Licence for Commercial Production of X-ray equipment and x-ray tubes:

• No activity shall be carried out by your institute for purposes other than those specified in this Licence.
• The radiation testing of the x-ray equipment and/or x-ray tubes shall be carried out in the location as per approved layout.
• The regulatory responsibilities of the employer, licensee and RSO as laid down in the Atomic Energy (Radiation Protection) Rules, 2004 or the latest revision of AERB Safety Code (AERB/SC/Med-2) shall be adhered to.
• Availability of qualified and trained personnel and personnel monitoring service to radiation workers shall be ensured all the time.
• All models of x-ray tube and x-ray tube insert to be imported/indigenously manufactured shall be registered with AERB through eLORA.
• For import/procurement of x-ray tube(s)/x-ray tube inserts, the manufacturer shall obtain NOC for import/permission for procurement from the competent authority.
• Prior to commercial production of every model of x-ray equipment the manufacturer shall obtain Type Approval from the competent authority, on demonstration of performance of the prototype of x-ray equipment. (Not applicable for x-ray tube manufacturers)
• Shall abide by the Quality Control procedure in manufacturing and ensure quality of x-ray tubes and the type approved model/s is maintained.
• Manufacturer shall ensure that before supply, their supplier(s) (if any) obtain AERB Authorization.
• The periodic safety status report in the prescribed format and frequency shall be submitted to AERB.
• In case there is change in information specified in this licence after its issuance, such as change of Employer, Licensee, name of institution it shall be ensured by licensee that the necessary amendment to this effect to the licence is obtained from the Competent Authority.
• The Licence shall be renewed before expiry.
• Facilities shall be accorded to any authorized inspector of the competent authority to inspect the facility at any time. Records on manufacturing/supply/Quality Assurance Tests /Type Approvals shall be made available.
• If part or complete activity of manufacturing is outsourced by the OEM, to any agency, it shall be the responsibility of the OEM to ensure that all the quality protocols in the manufacturing are duly complied with. The outsourced agency shall also be subjected to inspection by the regulatory body as applicable to OEM.
• Any incident involving radiation exposure to person shall be intimated to AERB immediately.
• For closure of manufacturing facility, the licensee shall obtain the requisite consent for decommissioning of the facility. All authorized suppliers shall be intimated in advance prior to actual decommissioning.
• This license may be suspended, modified or withdrawn as specified in the Atomic Energy (Radiation Protection) Rules, 2004, in the event of contravention of the provisions of the above Act / Rules / Codes or terms and conditions of the Licence. Where deemed appropriate, AERB may also initiate penal action against the Employer/licensee in such an event.