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Special Device Types

Radiation-Emitting Devices — LK-Unique Dual Approval​

Medical devices that emit ionising or non-ionising radiation require two separate regulatory approvals:

  1. NMRA — Registration Certificate and Import Licence (standard process)
  2. Atomic Energy Authority (AEA) of Sri Lanka — approval under the Atomic Energy Authority Act

Both must be obtained before the device can be commercially supplied. The processes are independent — progress with both in parallel. See Radiation-Emitting Devices.

Affected device types include: Diagnostic X-ray equipment · Dental X-ray units · Fluoroscopy systems · CT scanners · Radiation therapy equipment · Nuclear medicine equipment · DEXA bone densitometers · UV therapy lamps

Active Implantable Devices​

Active implantable devices (pacemakers, ICDs, cochlear implants, neurostimulators) are typically Class III and require the most rigorous registration pathway including MDEC review. Consider pre-submission consultation with the NMRA before preparing the dossier.

Devices Incorporating Medicinal Substances​

Products combining a device with a medicinal component may have elevated classification. The medicinal substance's role must be fully documented:

  • Is the substance ancillary to the device function?
  • Does the substance provide pharmacological activity?
  • What is the regulatory precedent in reference countries?

NMRA may consult with the drug regulatory division for borderline combination products.

Software & SaMD​

Classified and registered as medical devices. Required documentation includes IEC 62304, IEC 62366, ISO 14971 (for software hazards), and algorithm validation for AI/ML systems. See SaMD & Borderline Products.

Custom-Made Devices​

Devices manufactured to the specific requirements of an individual patient (custom-made devices) are generally exempt from standard NMRA registration. The manufacturer must maintain documentation of essential requirements compliance but formal NMRA listing is not required.

Devices Exempt from Registration — Waiver of Registration​

The following uses are exempt from NMRA registration but require a Waiver of Registration (WOR):

  • Devices used strictly for research purposes
  • Devices used in clinical trials
  • Exhibition devices at conferences (not for commercial supply)
  • Donated new devices provided to healthcare institutions

Apply for a WOR from the NMRA Medical Devices Regulatory Division. Provide:

  • Device description and approved research/exhibition purpose
  • Confirmation device will not be sold commercially
  • Institutional ethics approval (for clinical investigations)
  • Post-WOR: report adverse events; do not supply beyond approved use

Single-Use Devices (SUDs)​

Must be labelled as single-use. Third-party reprocessing of SUDs is a separate regulatory consideration that must be addressed if reprocessing is intended.

In Radiation-Emitting Devices section, change 'See Radiation-Emitting Devices.' to 'See Radiation-Emitting Devices for detailed guidance on dual approval processes and AEA coordination.'

For borderline cases where the medicinal and device components are inextricably combined, the NMRA may require a joint application or coordinated review with the medicinal products regulatory division.