Radiation-Emitting Devices
LK-Unique · Dual approval: NMRA + Atomic Energy Authority
Why Two Approvals Are Required
Medical devices that emit ionising or non-ionising radiation are subject to two independent regulatory requirements in Sri Lanka:
- NMRA — standard Registration Certificate and Import Licence (NMRA Act No. 5 of 2015)
- Atomic Energy Authority (AEA) of Sri Lanka — under the Atomic Energy Authority Act
Both approvals must be obtained before radiation-emitting devices can be commercially supplied in Sri Lanka. An NMRA registration without AEA approval is insufficient; the reverse is also true.
Affected Device Types
| Device Category | Examples |
|---|---|
| Diagnostic X-ray equipment | General radiography, fluoroscopy, C-arm units |
| CT scanners | Single, dual, and multi-slice |
| Dental X-ray units | Intraoral, panoramic, CBCT |
| Radiation therapy systems | Linear accelerators, brachytherapy, gamma knife |
| Nuclear medicine equipment | PET, SPECT, gamma cameras |
| Bone densitometry (DEXA) | Whole body and lumbar spine densitometers |
| UV therapy equipment | Phototherapy units for dermatology |
| Laser therapeutic devices | Class 3B and 4 therapeutic lasers |
NMRA Process — Standard
Follow the standard NMRA registration pathway:
- NMRA manufacturing facility registration (if foreign manufacturer)
- Consolidated Dossier (F-MDR-035) submission
- MDEC review (Class IIb/III devices)
- Registration Certificate issued
- Import Licence application