Regulatory Procedure for Obtaining Licence for Manufacturing of X-Ray Equipment
The mission of Atomic Energy Regulatory Board (AERB) in India is to ensure the use of ionizing radiation and nuclear energy does not cause extreme risk to the health of people and the environment.
Manufacturers of medical diagnostic x-ray equipment are required to obtain Licence for commercial production from Atomic Energy Regulatory Board (AERB) as per Atomic Energy Radiation Protection Rules 2004.
The manufacturer shall obtain import permission for x-ray inserts. He shall maintain data of testing of x-ray equipment.
Indigenous manufacturer (x-ray equipment) shall also obtain Type Approval certificate from the authority for the prototype of every model of x-ray equipment before manufacturing on commercial scale.
This regulatory process includes three steps:
- Licence for commercial production of X-Ray Equipment
- Type Approval
- Monitoring of Licensed manufacturer by AERB
GUIDELINES FOR MANUFACTURERS OF MEDICAL DIAGNOSTIC X-RAY EQUIPMENT
1) Licence for commercial production of X-Ray Equipment
The prerequisites for obtaining Licence are:
a) Layout and shielding shall be as per AERB requirements
b) Availability of qualified and trained service engineers, and approved Radiological Safety Officer (RSO) with Personnel Monitoring Services
c) Availability of necessary Quality Assurance equipment, survey meter and other associated equipment for performance evaluation (Diagnostic x-ray Equipment)
d) Personnel protective accessories
e) For RSO approval completely filled, duly signed and stamped application form (AERB/RSD/MDX-RSO)
- Certificates of qualifications -Copy
- Availability of Personnel monitoring badge for which he/she is nominated to become RSO.
- Completely filled duly signed and stamped application form (AERB/RSD/MDX/Manuf/CP-EQUIPand AERB/RSD/MDX/Manuf/CP-TUBE) shall be submitted to AERB along with enclosures as per the application form as applicable.
2)Type Approval
The following are the procedure for obtaining Type Approval
REQUIREMENTS FOR TYPE APPROVAL OF EQUIPMENT
1.NOC/Type Approval for Computed Tomography:
Application form: AERB/RSD/ MDX-CT-CATH/TA
- BIS certificate for local manufacturers -Copy
- IEC certificate-Copy
- Product technical catalogue
- X-Ray tube catalogue
- Detector/Image intensifier tube catalogue
- Quality Assurance report (as per AERB/RSD/MDX-CT/QAR/2010)
- Manual for installation, operation, servicing, maintenance, dismantling and decommissioning
- Quality Assurance (QA) Manual covering design and manufacturing aspects
In case of NOC for import equipment (In addition to the above requirements) Declaration from the original manufacturer/ designer authorizing the local supplier/vendor for marketing the unit with
2. NOC/Type Approval for Interventional Radiology (Cath- Lab)
- Application form: AERB/RSD/ MDX-CT-CATH/TA
- Quality Assurance (QA) report (as per AERB/RSD/MDX-IR/QAR/2010)
- All requirements as above
3. NOC/Type Approval for X-Ray units
- Application form: AERB/RSD/MDX/TA
- QA report (as per AERB/RSD/MDX-IR/QAR/2010
All requirements as above
4. NOC/Type Approval for Mammography
- Application form: AERB/RSD/MDX/TA
- QA report (as per AERB/RSD/MDXMAMMO/QAR/2010)
- All requirements as above
Conditions
- Manufacturers should submit Periodic Safety Report annually to AERB.
- Type approved equipment should be installed in the approved site of a facility.
- Acceptance Tests (QA) should be performed at each premises after installation.
- Manufacturer shall ensure that the user obtains the requisite regulatory consents from Atomic Energy Regulatory Board (AERB) for routine operation of RGE.
- List of the users to whom the Type Approved equipment is supplied shall be submitted to AERB every Quarter.
3) Monitoring of Licensed manufacturer by AERB
i) Periodic reporting to AERB: Manufactures shall submit quarterly report of activities carried out to AERB in the prescribed format
ii) Maintenance of records for Regulatory inspection
a) Quarterly reports submitted to AERB
b) A copy of valid Licence issued by AERB
c) List of authorized suppliers
d) Calibration records of QA and radiation survey equipments.
iii) Renewal of License:
- Initial Licence will be valid for a period of 5 years, which needs to be renewed before expiry.
- The application form for renewal of authorization shall be submitted to Head, RSD, Atomic Energy Regulatory Board (AERB) at least 2 months to the expiry.
- Renewal of Licence will be issued based on satisfactory performance during the period of Licence.
iv) Cancellation/Suspension of Licence:
- In case of violations of Terms and Conditions of the Authorization AERB may initiate appropriate regulatory action against the Agency, which may include fine and/or suspension /cancellation of authorization