Sample Import Licence (SIL) Process for Medical Devices in Sri Lanka

1. Key takeaways

Medical device samples cannot be imported into Sri Lanka as ordinary cargo; a Sample Import Licence (SIL) must be obtained first. Under the consolidated dossier route, the SIL application (Schedule IV, Form C) forms part of the PRD. The process runs as follows: the NMRA emails the approved Form C and the evaluation form to the applicant; the applicant submits the scanned documents to the Licensing Division and pays the fee in person; the SIL is issued; and the applicant returns a copy of the SIL, together with a covering letter, to the acceptance point to start the evaluation and obtain the receipt. Each of these steps depends on the one before it, so a delay at any link stalls the whole chain downstream.

• SIL form: Schedule IV, Form C, which is part of the PRD, under GL-034 (effective 23 July 2025).
• Trigger sequence: after FMSA approval on the FMSA plus PRD route, or depending on the product situation on the PRD-only route.
• Submission body: the Licensing Division.
• Follow-up action: copy of the SIL plus covering letter to the acceptance point, which starts the evaluation and yields the receipt.
• Sample declaration: the applicant must declare in the dossier that samples will be submitted whenever the NMRA requires them.
• Sample quantity: some applications require two product samples (practical estimate).
• Supplementary notices: the NMRA has issued notices on the submission and re-issuance of device SILs (May and July 2026).

2. Legal basis

The SIL process is anchored in GL-034, effective 23 July 2025, and in the notices published on the NMRA website. The table below records the form used, the sequence that triggers it, the division involved, and the follow-up actions that close the loop. Reading the rows in sequence gives the complete life of a SIL, from the form entering the PRD to the receipt that confirms the evaluation has started.

One structural point helps when planning around this table. The SIL stage belongs to the applicant’s side of the process: the NMRA approves the form and issues the licence, but every movement between the divisions is driven by the applicant. That is why the follow-up row, the return of the SIL copy to the acceptance point, sits squarely in the applicant’s task list and not in the authority’s queue.

3. Expert insights

Insight one: the SIL is not an extra step; it has been integrated into the PRD. Under the old process, the site, the samples and the product were three separate applications; under the consolidated dossier, the SIL is one part of a single submission. This reduces the friction between process stages, but it raises the completeness required at the first submission. The Form C has to be ready when the consolidated dossier is assembled, because there is no later window in which to add it as an independent filing.

Insight two: the SIL and the start of the evaluation are bound together. After the SIL is issued, its copy must still be returned to the acceptance point, and only then does the evaluation formally start. If that final step is missed, the dossier stalls at acceptance status. Teams that treat the issuance of the SIL as the finish line leave the file parked indefinitely, which is why the return-and-receipt action must be tracked as its own deliverable with a named owner.

Insight three: the low-risk channel may not need a SIL at all. The GL-037 low-risk checklist does not list a sample import licence application item; whether a specific product needs one should be confirmed with the NMRA (see Articles 13 and 48). Manufacturers on the low-risk channel should therefore not order samples or book testing logistics before confirming the SIL requirement, since the answer changes the cost and timeline of that route materially.

4. Practical recommendations

• Manage the SIL as an independent milestone: after dossier submission, set up a three-state SIL board, covering awaiting NMRA approval of Form C, fee paid and licence pending, and licence issued and awaiting return to the acceptance point.
• Mark each state with a responsible person and an expected date, so a stalled handover is visible immediately.
• Remember that delays in the sample stage often come not from slow testing but from broken handovers between states.
• Confirm with the NMRA whether the specific product needs a SIL before paying for sample logistics, particularly on the low-risk channel.
• Check the May 2026 and July 2026 notices on SIL submission and re-issuance before filing, so the current procedure is followed.
• Include the sample declaration in the dossier text from the first draft, since it is a required statement rather than an afterthought.

5. Verification checklist

• □ It has been confirmed whether the product needs sample import
• □ Form C (Schedule IV, Form C) has been included in the PRD
• □ The approved Form C and the evaluation form have been received from the NMRA
• □ The scanned documents have been submitted to the Licensing Division and the fee paid
• □ The SIL has been obtained
• □ The copy of the SIL and the covering letter have been returned to the acceptance point and the receipt obtained
• □ The sample submission declaration has been made in the dossier

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across South Asia, including Sri Lanka. Our team prepares dossiers to NMRA expectations, manages submissions and deficiency responses, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com

Regulatory information verified as of 28 October 2026.