All stakeholders, including manufacturers, importers, suppliers, health care facilities, and users of medical devices, are hereby informed that the official reporting formats for adverse events related to medical devices, including in vitro diagnostics (IVDs), are now available on the “Report Adverse Events” tab under the Medical Devices Regulatory Division on the NMRA website.

The following three (03) reporting forms have been published for use by the relevant parties:

1. Adverse Event Reporting Form for Importers / Supplier
2. Adverse Event Reporting Form for Manufacturer
3. Adverse Event Reporting Form for Consumers and Healthcare Facilities

All stakeholders are advised to use the relevant prescribed form when reporting any adverse event, malfunction,deterioration in performance, or safety-related issue associated with medical devices and IVDs, in line with regulatory requirements.

Timely and accurate reporting of adverse events is essential to ensure the safety, performance, and continued monitoring of medical devices used in Sri Lanka.

For further information or clarification, stakeholders are advised to refer to the NMRA website under Regulatory → Medical Devices → Report Adverse Events.

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