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
Waiver Validity and Extension
A Waiver of Registration is typically issued for a specific period aligned with the approved use (e.g., duration of a clinical trial, one-year exhibition permit). The applicant must reapply or seek an extension if the exempt use will continue beyond the original waiver period. Extensions should be requested from NMRA before the waiver expires. If the device is no longer used for the approved exempt purpose, NMRA must be notified immediately and the device must be returned, destroyed, or formally withdrawn.