Sri Lanka Free Sale Certificate and Reference Country Approvals

1. Key takeaways

The Sri Lankan PRD dossier requires two categories of external evidence: a Free Sale Certificate (FSC) issued by the country of origin, and registration certificates from other countries. The latter carries decisive weight under the reliance pathway — it determines whether sample import and performance evaluation can be exempted. The two documents perform different jobs and travel through different issuing channels: the FSC attests that the product is lawfully sold in its origin market, while the foreign registration certificates attest that recognised authorities have already assessed the product. Because the reliance pathway can materially shorten and simplify the route to approval, the quality of the external evidence — its validity, its scope, and its consistency with the product being submitted — is not a clerical matter but a strategic one. A dossier built on well-managed external evidence can avoid substantial technical work; the same dossier built on lapsed or inconsistent evidence loses that advantage entirely, and often discovers the loss at the worst possible moment.

• A valid FSC issued by the country of origin is required (GL-034 material list; industry compilation).
• Registration certificates from other countries, including reference countries, form the second evidence category.
• Reliance reference countries for general devices: the United States, the United Kingdom, Australia, Canada, Japan, Norway, Switzerland, and all European Union member states (industry compilation).
• For IVDs the reference list adds Singapore to the above.
• Reference approvals must be within their validity period and in normal status, and product models and specifications must be fully consistent with the reference approval.

2. Legal basis

The FSC and the letter of authorisation derive from the GL-034 material list and its administrative documents section. The reference-country lists, the validity condition, and the consistency requirement are compiled from industry compilation and are marked accordingly. Together they define what valid external evidence looks like and when it supports the reliance pathway.

3. Expert insights

Insight one: the FSC and the overseas registration certificates are two different documents and cannot replace each other. The FSC proves lawful sale in the country of origin; the overseas registration certificates support the applicability of the reliance pathway. Submitting only the FSC is equivalent to giving up the reliance pathway. This is a genuine strategic loss, not a paperwork shortfall: a product with reference approvals that are never submitted forfeits the exemptions those approvals could have unlocked, and pays in sample import and performance evaluation work that the evidence could have avoided. Every submission plan should therefore state explicitly which external evidence is being relied on, and why.

Insight two: the geographic scope of the reference-country list is by country or region. The European Union is expressed as all EU member states, which means that in principle a CE approval from any member state can be counted within the recognition scope, although the specific applicability remains subject to NMRA determination. The wording matters when selecting which approval to lead with: an approval from a smaller member state is not disqualified by the size of its authority, provided it meets the other conditions. What it must satisfy, without exception, is the validity and consistency requirement — an approval that has lapsed, or that covers a configuration different from the product submitted, contributes nothing.

Insight three: the consistency requirement extends to the packaging level. The rules note explicitly that seemingly minor changes such as packaging or colour can cause the reliance to fail. Accessories and packing lists should be included in the consistency check. This catches many teams by surprise, because packaging changes are routine commercial decisions that never touch the regulatory file. When the artwork, configuration, or accessories diverge from what the reference approval describes, the link between the approval and the product submitted is broken, and the reliance argument collapses even though every certificate is otherwise in order. The disciplined response is to treat the reference approval as the master definition of the product — models, specifications, accessories, packaging — and to route any commercial change through a consistency review before it is implemented for the Sri Lankan market.

4. Practical recommendations

• GRZAN establishes an external evidence register for clients: for each FSC and each country’s registration certificate, it records the issuing body, the document number, the issue date, the validity period, and the covered models and specifications, and sets expiry reminders.
• The register is updated once before every submission and every renewal, keeping the evidence chain continuously valid.
• Run the consistency check across models, specifications, accessories, and packing lists against each reference approval before the dossier is finalised, not after.
• Confirm the notarisation or legalisation chain for every external evidence document where applicable, since an unauthenticated document can be rejected on formal grounds regardless of its content.

5. Verification checklist

• □ Country-of-origin FSC obtained and within its validity period
• □ FSC covers the models and specifications of the product submitted
• □ Overseas reference country registration certificates compiled
• □ Reference country approvals within their validity period and in normal status
• □ Models / specifications of the product submitted verified item by item against the reference approval
• □ Notarisation or legalisation chain completed for all external evidence documents (where applicable)

Regulatory information verified as of 28 October 2026.

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