Reissuance of Sample Import License (SIL)-Medical Devices

Applications for the reissuance of a Sample Import License (SIL) will be considered under the following instances:

Applicable instances:

• Expiry of the SIL prior to the importation of samples for clinical evaluation
• Requirement of additional samples as requested by the relevant clinical evaluation panel

Applications submitted under the above circumstances must be accompanied by the following mandatory documents:

Mandatory documents:

• Duly completed Application (Schedule IV / Form C)
• A formal request letter for issuance of a new SIL
• Evidence for the request made by NMRA for samples/additional samples for clinical evaluation (e.g., copy of email)
• A letter from Sri Lanka Customs confirming whether the specified product has or has not been imported into Sri Lanka.
• A copy of the previously issued SIL

Please note that submission of all mandatory documents is required. The authority may request additional documents where necessary.

CEO, NMRA

Click Here : Web Notice

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