Sri Lanka New Application Fees for Foreign and Local Applicants

1. Key takeaways

Sri Lanka’s new application processing fee is set in three tiers by applicant type: Foreign 1,000 US dollars; Local – Category A 750 US dollars; Local – Category B 250 US dollars. Using the April 2026 monthly fee schedule (conversion rate 319.312 rupees per dollar), the rupee totals for the three tiers are 386,207.86, 289,655.90, and 96,551.97 rupees respectively, each inclusive of 18% VAT and 2.5% SSCL. The spread between the foreign and the lowest local tier is fourfold, which makes the applicant classification one of the first cost determinations in any Sri Lankan project, and one that should be confirmed before the budget is presented rather than after the invoice arrives. Note also that the schedule has a defined validity window: the April 2026 schedule ran from 2026-04-01 to 2026-04-30, after which the next monthly schedule with a new conversion rate took over. Any calculation performed for a submission planned in a later month must therefore be re-run against that month’s schedule, not carried over from April’s figures.

• Foreign new application: 1,000 USD, rupee total 386,207.86 (including 18% VAT and 2.5% SSCL).
• Local – Category A: 750 USD, rupee total 289,655.90.
• Local – Category B: 250 USD, rupee total 96,551.97.
• Conversion rate for the April 2026 schedule: 319.312 rupees per dollar (CBSL selling rate of 2026-03-31).
• The schedule is valid from 2026-04-01 to 2026-04-30.
• The stamp duty column is shown as — in the fee schedule.

2. Legal basis

The tiered fees are published in the NMRA medical device monthly fee schedule. The table below reproduces the three tiers exactly as listed, with the converted amounts, VAT, SSCL, and totals as they appear for the April 2026 schedule.

Data source: NMRA medical device monthly fee schedule (the April 2026 schedule, valid from 2026-04-01 to 2026-04-30; the conversion rate is the dollar selling rate of 319.312 published by CBSL on 2026-03-31). The stamp duty column is shown as “—” in the fee schedule.

3. Expert insights

Insight one: the gap between foreign and local applicants is fourfold (1,000 versus 250). This spread shows that Sri Lanka prices the review effort for foreign applicants significantly higher than for local ones. Companies building cost models must not estimate on local-basis figures. A model that quietly assumes the local tier will understate the foreign application cost by a factor of four, an error large enough to distort the whole market-entry decision. Whenever a comparator figure circulates internally, the first question should be which tier it was drawn from.

Insight two: the Local Category A / Category B split is based on category, not on risk class. This means the fee for a local manufacturer depends on the category into which it is placed, and the classification basis should be confirmed before the application is filed. Two local manufacturers with similar products may sit in different categories and pay different fees, so the category determination is a factual input to the budget, not an administrative footnote. In practice, the category is established through the information provided in the application form, so the form entries and the fee tier should be reconciled before payment, in the same way the dollar amount is reconciled against the schedule.

Insight three: the fee schedule is updated monthly, so every quotation must carry its date. We require all outgoing quotations to state that the NMRA monthly fee schedule of the month of submission prevails, which avoids disputes triggered by exchange-rate movements. A quotation without its month invites the counterparty to assume today’s rate will hold indefinitely, and when it does not, the difference becomes an argument. With the month stated, the reference point is agreed in advance and the variance has an owner. Together with the yellow receipt procedure — obtain the receipt after payment and return it to the receiving point — these habits close the loop on both the pricing and the documentary side of the fee. Read together, the tier table, the monthly validity window, and the receipt procedure form a complete payment protocol that can be applied to every new application the manufacturer files in Sri Lanka.

4. Practical recommendations

• GRZAN’s approach is to bind fee items to process stages in a single table: which payment falls at which stage, under which type it is charged, and when it is due. This lets clients see the cash-flow distribution directly when planning the budget, instead of receiving one lump total.
• For projects with a portfolio of multiple products, this stage-by-stage fee table is especially important, because the payments recur per product and their timing drives the cash requirement.
• Confirm the applicant type (foreign, Local – Category A, or Local – Category B) before quoting, since the tier determines the base fee.
• Check the dollar amount and converted rate against the current monthly fee schedule for the month of submission.
• Include 18% VAT and 2.5% SSCL in every total presented to the client, never quote the bare converted figure.
• Confirm that after payment the yellow receipt is obtained and returned to the receiving point, completing the payment record for the file.

5. Verification checklist

• □ The applicant type has been confirmed (foreign / Local – Category A / Local – Category B)
• □ The dollar amount and converted rate have been checked against the current monthly fee schedule
• □ 18% VAT and 2.5% SSCL have been included
• □ The applicable month has been stated on the quotation
• □ It has been confirmed that the yellow receipt is obtained after payment and returned to the receiving point

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.