Sri Lanka Independent Licence Holder with a Separate Channel

1. Key takeaways

An Independent License Holder is a local entity that does not take part in channel distribution, but exists solely to hold the registration certificate and perform the statutory duties of the licence holder. In Sri Lanka this role is legitimate: the rules only require the MAH to be a locally registered commercial entity, and do not require it to be a distributor. The core value of the arrangement is simple and powerful: when the distribution channel changes, the certificate does not move. The manufacturer keeps continuity of its authorization while retaining full freedom to appoint, replace, or renegotiate with distributors, because the certificate is anchored to an entity whose only business is holding it responsibly.

• An Independent License Holder holds the certificate and performs statutory MAH duties without participating in distribution.
• The role is valid because the rules require the MAH to be a locally registered commercial entity, not a distributor.
• The central benefit: changing the channel leaves the registration certificate untouched.
• The Letter of Authorization (LOA) is the pivotal document that makes the structure work.
• Multiple-agent situations follow a specific rule under GL-034: a tabulated LOA listing all local agents, product scope, and manufacturing sites.

2. Legal basis

The foundation is the same NMRA requirement that governs every MAH appointment, supplemented by the GL-037 exemption for listed devices. The table below sets out the legal elements on which the independent-holder structure rests.

Nothing in this framework requires the certificate holder to sell anything. The duties are duties of custody and compliance: holding the authorization, answering the authority, notifying changes, and carrying responsibility for the product on the market. An entity can perform all of these without ever handling a shipment, which is precisely what makes the independent-holder model lawful. For foreign manufacturers weighing the option, the model trades a service fee for optionality: the certificate survives every distributor change, every channel renegotiation, and every market-entry experiment, so the authorization behaves like an asset owned by the manufacturer rather than a hostage of the channel. The GL-037 date matters operationally as well, because manufacturers relying on the listed-device exemption can plan site-registration work around the effective date of 2026-05-13.

3. Expert insights

Insight one: the independence of an independent holder carries a legal cost. It is not a figurehead position — the MAH must collect and report vigilance information, cooperate with market inspections, and coordinate recalls. Appointing a holder that is willing to lend its name but unwilling to bear responsibility simply plants a problem for later. When an incident occurs, the holder will be the one the NMRA contacts, and a passive holder at that moment converts a manageable event into a crisis. Manufacturers should therefore screen independent-holder candidates for genuine compliance capability, not just registration documents.

Insight two: the Letter of Authorization (LOA) is the pivotal document of this structure. Through the LOA the manufacturer grants the MAH the authority to apply for and hold the registration in Sri Lanka. The scope of the LOA, its term, whether sub-delegation is permitted, and how it is handled on termination directly determine whether the structure is stable. A narrow, well-bounded LOA gives the holder exactly enough authority to perform its duties and nothing more; an open-ended one exposes the manufacturer to actions taken in its name without its knowledge.

Insight three: multiple-agent situations have a dedicated rule. GL-034 requires that where the legal manufacturer appoints several local agents, a tabulated LOA must be submitted, listing all local agents, the product scope, and the manufacturing sites. This prevents overlapping or contradictory authorizations from reaching the review. A manufacturer intending to run parallel agents should prepare the tabulated form from the outset, because an incomplete appointment is a deficiency waiting to be raised.

4. Practical recommendations

• When reviewing an LOA for this structure, watch four clauses: the authorization term (recommended not shorter than the 5-year validity of the registration), the termination notice period (recommended no less than 90 days), the post-termination cooperation duties (certificate transfer, handover of technical documentation), and the manufacturer’s warranty of the product’s own compliance.
• Treat a one-page LOA with no substantive terms as a defect: an LOA that says almost nothing will certainly cause problems when the channel changes.
• Define the vigilance collection and reporting split between manufacturer and holder in the technical agreement, so the statutory duty has an operational owner for each step.
• Where several agents are appointed, prepare the tabulated LOA listing every local agent, the product scope, and each manufacturing site, as required by GL-034.
• Confirm that the holder entity is locally registered and operationally able to answer NMRA queries during the review and after approval.
• Keep the certificate anchored to the independent holder even when distributors change, so renewal and change filings remain continuous.

5. Verification checklist

• □ The LOA term covers the 5-year validity of the registration
• □ A termination notice period has been agreed (recommended ≥90 days)
• □ Post-termination certificate-transfer and document-handover duties have been agreed
• □ The division of vigilance collection and reporting has been defined
• □ For multiple agents, the tabulated LOA has been submitted
• □ All local agents, product scope, and manufacturing sites have been listed

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.