Licencing and Approvals
Sri Lanka Atomic Energy Regulatory Council (Council) as the regulatory authority in Sri Lanka is responsible as per Sri Lanka Atomic Energy Act No.40 of 2014 (Act) to regulate uses of ionizing radiation sources and practices in Sri Lanka. Regulation of sources and practices is done through the process of authorization which include licensing and approvals. Approvals are given for facility plans and import & export of radioactive sources and irradiating apparatus (X-ray machines, linear accelerators etc.). To use radiation in all other activities a licence from the Council is required. As per the Act, regulatory activities of the Council are limited to non-power applications in medicine, industry, teaching and agriculture using radioactive material and nuclear material. Provision is not given for regulate construction and operation of a nuclear power plant.
Wide range of radiation sources, generators, and associated equipment are used in Medical, Industrial, agriculture and research fields giving enormous benefits to Sri Lankan population. The potential hazard in these applications are different as amount of radioactive material used in these applications have vast differences and therefore imposing regulatory requirements, these differences are considered to provide safety of people and security of sources based on the risk associated with the sources.
The Council’s process for issuing a licence is as follows. The applicants who have intention to commence a practice should act as follows.
Send a duly filled “Notification of intention to conduct a practice form” using the form available in the Gazette No. 1924/27 dated 21st July, 2015 (available in the Download section)
Submit a duly filed application to obtain an approval to the facility plan (Forms are available in the Download section)
Submit a licence application for obtaining a licence to use the sources (Relevant application forms are available in the Download section)
If any radioactive sources or X-ray machines are required to be imported or exported, an approval should be obtained from the Council (Relevant application forms are available in the Download section)
The Licence for any new facility and sources are given only after an inspection and facility is conform to the radiation protection requirements of the Council. Renewal licences are issued pending an inspection during the period of the licence.
Licencing periods for different practices are as follows
| Practice | Source Type | Maximum period of validity of the licence |
| Radiotherapy using ionizing radiation | Tele-Gamma facility/Gamma knife facility/Brachytherapy facility | 01 year |
| Linear Accelerator facility/Tomotherapy facility/ X-ray Facility/ Therapy simulators and a similar facility | 02 years | |
| Sterilization and food preservation, blood and tissue irradiation using ionizing radiation | Dry storage or Pool type Irradiation facility | 01 year |
| Gamma irradiation chamber/Electron beam accelerator/X-ray machine | 02 years | |
| Industrial radiography using ionizing radiation | Gamma /neutron and beta radiography source/X-ray machine | 01 year |
| Applications in Nuclear Medicine | Therapy using unsealed sources | 01 year |
| Diagnosis using unsealed sources for in vitro or in vivo | 02 years | |
| Medical radiography using ionizing radiation | Interventional radiological X-ray unit/ Angiography X-ray unit / CT scanner/ Mammography/ General radiography | 02 years |
| Dental X-ray machine/ Veterinary X-ray machine/ Bone density scanner | 03 years | |
| Applications of ionizing radiation in industry, research and education | Particle accelerators/ neutron generators/ nucleonic gauge /well logging source/ lightening arresting device | 02 years |
| Analytical X-ray equipment/ An analytical equipment containing radioactive sources | 03 years | |
| Cabinet X-ray unit | 03 years | |
| Sealed and unsealed sources: Total activity less than 37 Giga Becquerel (1 Curie) | 03 years | |
| Sealed and unsealed sources: Total activity more than 37 Giga Becquerel (1 Curie) | 02 years | |
| Unsealed sources in tracer application | 03 months | |
| Commercial production of radioactive material of radiation generating equipment | Radioisotope production facility/ cyclotron facility | 01 year |
| An X-ray unit/ linear accelerator/ nucleonic gauge | 02 years | |
| Transport of Radioactive sources | All sources | 01 year |
| Service and maintenance of sources | All sources | 02 years |
| Radioactive waste management and/or storage | All sources including nuclear and fissionable materials | 01 year |
| Disposal and discharge of radioactive sources | All sources | 01 year |
| Sale of radioactive sources and Irradiating apparatus | All sources | 01 year |
| Applications using ionizing radiation which do not come under above practices | Aggregate radioactivity of sources less than Giga Becquerel 370 (10 Curie) | 02 years |
| Aggregate radioactivity of sources more than Giga Becquerel 370 (10 Curie) | 01 year | |
| Irradiating apparatus | 02 years |
Design approval is required for use above practices and details of the design approvals are as follows
- Design approval for a General Radiography X-ray/ Mammography / Dental X-ray / Bone Density Scanner/ Body Scanner/ Cabinet X-ray/ Baggage Scanner/Cone Beam CT
- Design approval for a CT/ Fluoroscopy/ Angiography / Other similar facilities
- Design approval for a Radiation Therapy Facility
- Design approval for a Pool Type Irradiator facility
- Design approval for a Self-shielded Irradiator facility
- Design approval for a Nuclear Medicine facility/ an Iodine therapy facility
- Design approval for a Cyclotron (below 7 MeV) facility
- Design approval for a Cyclotron (above 7 MeV) facility
- Design approval for a PET CT/ Gamma Camera facility
- Design approval for a Cyber Knife/ Gamma Knife/Other similar facility
- Design approval for a Container inspection facility/Vehicle scanning facility
- Design Approval for NDT Facility
All other approvals and their periods for Import/ Export/ Customs Clearance /No objection/ Transit are as follows
| Type of Source | Maximum period of validity of an approval/ an extension of an approval |
| Radioactive materials with a total activity of a consignment 3,700 Giga Becquerel (100 Curie) or more | 01 month/ 03 months/ 01 year |
| Radioactive materials with a total activity of a consignment less than 3,700 Giga Becquerel (100 Curie) | 01 month/ 03 months/ 01 year |
| Dental X-ray machine /Cone beam CT/similar type (Per machine) | 01 year |
| All types of diagnostic X-ray machines (Per machine) | 01 year |
| X-ray machines other than diagnostic x-rays/linear accelerator/ tele therapy machine/ brachytherapy used in medicine and X-ray machines in MeV range used industry (per machine) | 01 year |
| Cabinet X-ray machine / Analytical devices/ body scanner for Security purpose (Per machine) | 01 year |
| Transport through airport | Up to 03 months |
| Associated equipment used in nuclear medicine (PET CT/SPECT/ Gamma camera) | 03 months |
| Cyclotron | 3 months |
| No objection letters | 03 months/ more than 03 months |
| Approvals which do not come under the above | Up to 01 year |