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:

1. NMRA — standard Registration Certificate and Import Licence (NMRA Act No. 5 of 2015)
2. 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:

1. NMRA manufacturing facility registration (if foreign manufacturer)
2. Consolidated Dossier (F-MDR-035) submission
3. MDEC review (Class IIb/III devices)
4. Registration Certificate issued
5. Import Licence application

Include AEA approval status in the NMRA application where known.

Atomic Energy Authority Process

Contact the Atomic Energy Authority of Sri Lanka directly for current requirements. The AEA process typically covers:

• Technical specifications of the radiation source and emission characteristics
• Radiation safety design documentation
• Operator qualification requirements
• Installation and commissioning standards
• Radiation protection measures

AEA Contact: www.aea.gov.lk

Parallel Processing — Recommended

Both processes should be run in parallel to minimise total time to market. Key points:

• Start AEA engagement early — the AEA process timeline may differ from NMRA
• The NMRA and AEA processes are independent — approval from one does not confer or accelerate approval from the other
• Budget for two separate approval processes with potentially different fee structures
• Document both approvals clearly for customs clearance purposes

Ongoing Compliance

After market approval:

• AEA approval may have conditions regarding installation, commissioning, and periodic inspection
• Radiation-emitting equipment in clinical use is typically subject to periodic AEA inspection
• Adverse events involving radiation emissions must be reported to both NMRA and AEA as applicable