National Medicines Regulatory Authority

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.

‍

When the actual shipper/supplier is different from the manufacturer mentioned in the Registration Certificate, you are kindly requested to upload a copy of the Letter of Authorization issued by the manufacturer to the shipper/supplier to the STRATLINK/ASYCUDA system.

Medicines Regulatory Division,

NMRA.

‍

This is to notify all Authorized Local Agents that the following is the Third list (List 03) of approved MRP revisions due to currency depreciation.This list includes MRP revision applications reviewed and approved by the Pricing Division/NMRA up to 28th September 2026.

Please note that, hereinafter, individual emails will not be sent to Local Agents to notify pricing approvals for MRP revisions due to currency depreciation, as the updated list will be published on the NMRA website.

Accordingly, all relevant Authorized Local Agents are hereby requested to check the published lists and submit the relevant valid Import Licenses to the NMRA Licensing Unit without delay. Your prompt attention and cooperation in this regard are highly appreciated to avoid any further delays in processing the respective applications."

Click Here : The list of approved MRP Revisions due to currency depreciation_List 3

Notice to All Marketing Authorization Holders (MAHs)

Please be informed that the public day schedule for Monday, 28 September 2026 at the Pricing Regulatory Division has been rescheduled to Wednesday, 30 September 2026, due to unavoidable circumstances.

We regret any inconvenience caused and appreciate your cooperation.

Thank you,

CEO, NMRA

‍

Notice to all Authorized Local Agents,

Subject: Publishing the list of approved MRP Revisions due to currency depreciation_List 2

NOTICE TO ALL AUTHORIZED LOCAL AGENTS

This is to notify all Authorized Local Agents that the following is the second list (List 02) of approved MRP revisions due to currency depreciation. This list includes MRP revision applications reviewed and approved by the Pricing Division/NMRA up to 21 September 2026.

Please note that, hereinafter, individual emails will not be sent to Local Agents to notify pricing approvals for MRP revisions due to currency depreciation, as the updated list will be published on the NMRA website.

Accordingly, all relevant Authorized Local Agents are hereby requested to check the published lists and submit the relevant valid Import Licenses to the NMRA Licensing Unit without delay. Your prompt attention and cooperation in this regard are highly appreciated to avoid any further delays in processing the respective applications.

Click Here : The list of approved MRP Revisions due to currency depreciation_List 2