Sri Lanka Reliance Pathway Effective October 2025: Benefits and Class III Exclusion

1. Key takeaways

The Sri Lankan Reliance Pathway, also called the Global Recognition Pathway, took effect in October 2025 and applies to devices that have already been approved by a recognised reference regulatory authority. Its two substantive benefits are straightforward: exemption from sample import and exemption from the performance evaluation, which together significantly shorten the approval cycle. The pathway, however, carries one hard exclusion that shapes who can use it: Class III devices are not eligible at the present time. Manufacturers should therefore treat the pathway as a fast lane reserved for devices at other risk classes that already hold qualifying foreign approvals, and plan Class III projects on the standard route from the outset.

In practice, the pathway rewards companies whose regulatory footprint already extends into the major reference jurisdictions. For them, the October 2025 change converts certificates they already possess into real schedule savings in Sri Lanka. For companies without reference approvals, the pathway changes nothing, and the standard consolidated route with its sample and evaluation stages remains the only option.

• The pathway became effective in October 2025.
• Eligibility requires approval from a recognised reference jurisdiction.
• Benefit one: exemption from sample import.
• Benefit two: exemption from the performance evaluation.
• Exclusion: Class III devices do not qualify.
• Reference jurisdictions cover the European Union, the United States, the United Kingdom, Canada, Australia and Japan; for IVDs, Singapore is added.
• System background: the NMRA regulates devices under Act No. 5 of 2015, and the MDEC is responsible for technical evaluation.

2. Legal basis

The pathway rests on NMRA announcements from October 2025 and on the statutory framework of Act No. 5 of 2015. The table below collects the effective date, the eligibility conditions, the two exemptions, the exclusion and the recognised reference jurisdictions in one place.

3. Expert insights

Insight one: the value of the reliance pathway concentrates at the sample stage. Because ordinary sample import first requires a SIL and then local laboratory testing, that chain is the most time-consuming and least controllable segment of the Sri Lankan timeline. Exempting it delivers more practical acceleration than simply speeding up desk review. For products that qualify, the pathway effectively removes the logistics of shipping samples, clearing customs, booking local testing capacity and waiting for laboratory results, which is where many Sri Lankan projects silently lose months.

Insight two: the Class III exclusion keeps high-risk devices out of the fast lane. This runs against the intuition, common in many markets, that high-risk products are precisely the ones that most need to rely on reference-country conclusions. Manufacturers planning for Sri Lanka must accept this point rather than extrapolate from other markets. A Class III project should be scheduled on the full route from the beginning, including the sample and evaluation stages that the reliance pathway would otherwise waive, so that the timeline presented to management reflects reality.

Insight three: the reliance pathway and the GL-037 low-risk channel are two different doors. The low-risk channel looks at the product category (Listed, Class I or Class A) and whether the product is sterile, active or has a measuring function; the reliance pathway looks at whether an approval from a reference jurisdiction exists. The two doors can be assessed separately, and they can also be considered together. A product that qualifies for both should be examined carefully, because the applicable exemptions and the supporting evidence differ between the two routes, and the stronger basis should anchor the submission strategy.

4. Practical recommendations

• Start with an inventory of reference-country approvals: list every approval the product already holds, such as FDA 510(k) or PMA clearances, EU CE certificates under the MDR or IVDR, UK UKCA registration, Canadian MDL, Australian ARTG inclusion, and Japanese PMDA approvals.
• Check each approval item by item against the NMRA-recognised scope, its validity period, and whether the model and technical specifications exactly match the product being submitted.
• Only when all three checks pass does the product have the basis for the reliance pathway.
• Confirm the product is not Class III, since no combination of foreign approvals can overcome that exclusion.
• Keep the notarised or certified chain of the reference-approval evidence documents ready for review.
• Document the eligibility analysis in the project file so that the choice of route can be explained if NMRA queries it.
• Re-verify the reference approvals shortly before filing, because an approval that lapses between the inventory and the submission date undermines the entire route choice.
• Where the inventory shows partial matches, treat the gaps as a project decision: either cure them before filing or revert to the standard route, rather than filing on a shaky reliance basis.

5. Verification checklist

• □ The reference-country approvals already held by the product have been inventoried
• □ The approvals have been checked for validity within their period of effect
• □ The model and technical specifications have been checked for exact match with the product being submitted
• □ It has been confirmed that the product is not Class III (otherwise the reliance pathway does not apply)
• □ The notarised or certified chain of the reference-approval evidence documents has been retained
• □ The route decision has been recorded together with its supporting analysis

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.