Exemptions & Waiver of Registration
Devices Exempt from Registration
The following device uses do not require NMRA Registration Certificate or Import Licence, but require a Waiver of Registration (WOR):
| Exempt Use | Examples |
|---|---|
| Strictly for research purposes | Non-clinical laboratory research only |
| For use in clinical trials | Investigational devices in approved clinical studies |
| For exhibition at conferences | Demonstration at medical conferences; not placed on market |
| Donated new devices to healthcare institutions | Charitable donations of new (not refurbished) devices |
Waiver of Registration (WOR) Application
To bring exempt devices into Sri Lanka, the institution or researcher must apply for a WOR from the NMRA Medical Devices Regulatory Division.
Application Requirements
Submit to NMRA:
- Written application describing the device and its approved exempt purpose
- Confirmation that the device will NOT be placed on the commercial market or sold
- Institutional ethics committee approval (for clinical investigation use)
- Device description and specifications
- Details of the institution/researcher responsible
Post-WOR Obligations
Once a WOR is granted:
- Report adverse events involving the device to NMRA
- Do not supply the device to third parties beyond the approved use
- Return or destroy the device at the end of the approved purpose
- Notify NMRA if the device is no longer being used for the approved purpose
Custom-Made Devices
Devices manufactured to the specific requirements of an individual patient (custom-made devices) are generally exempt from NMRA registration requirements. The manufacturer must maintain documentation demonstrating compliance with essential requirements, but formal NMRA registration is not required.
What qualifies as custom-made:
- Manufactured specifically for a named individual patient
- Under the written prescription of a clinician
- Not manufactured in series
- Not the same design as devices ordinarily available on the market