Sri Lanka Marketing Authorization Holder: Mandatory Local Representation

1. Key takeaways

Sri Lanka requires all foreign medical device manufacturers to submit registration applications through a local Marketing Authorization Holder (MAH), also referred to as a local agent. The wording on the NMRA website is that foreign manufacturers should submit their applications through an MAH in Sri Lanka, and that the MAH shall assume responsibility for the registration, licensing, import, sale and distribution of the device, for the handling of quality incidents, and for all other matters relating to the device in Sri Lanka. The obligation is therefore not a formality of filing: the MAH is the accountable local entity for the entire lifecycle of the product in the market. The selection of the MAH, the allocation of vigilance duties between the manufacturer and the MAH, and the internal notification mechanisms that make those duties workable are all decisions that should be taken before the dossier is submitted, not after a problem arises.

• All foreign device manufacturers must submit applications through a Sri Lankan MAH.
• The MAH is responsible for registration, licensing, import, sale, distribution and quality incident handling.
• The applicant is fully responsible for the product and for the accuracy, completeness and truthfulness of all information provided.
• Changes, including regulatory status in other countries and cGMP compliance, must be notified promptly.
• The MAH must provide supplementary data or clarifications during review when requested.

2. Legal basis

The table below sets out the mandatory local representation requirement, the scope of MAH responsibilities as stated by NMRA, the obligations of the applicant, and the institutional character of the authority against which these duties are enforced.

3. Expert insights

Insight 1: the responsibility of the MAH is of the catch-all kind, not the filing kind. The MAH does not merely forward documents; it bears full responsibility for registration, licensing, import, sale, distribution and quality incidents. This determines that the selection of the MAH is a compliance decision, not a logistics decision. A partner chosen for its warehousing capacity or price list alone may prove unable to answer a regulatory query, respond to a quality incident or coordinate a recall, and because the obligation sits with the MAH as a matter of the NMRA requirement, the manufacturer cannot reassign that accountability after the fact. The due diligence applied to MAH candidates should therefore mirror the due diligence applied to the product itself.

Insight 2: one item on the obligation list is easily overlooked, namely the “regulatory status in other countries”. NMRA requires the MAH to notify situations in which the product has been rejected or withdrawn in other countries. This is a cross-border information obligation: the manufacturer must establish a corresponding internal notification mechanism that feeds regulatory decisions from any market into the Sri Lankan MAH promptly, otherwise the MAH cannot perform its duty. Companies operating in many markets should define who monitors foreign regulatory outcomes, in what format the information is transmitted, and within what period it must reach the MAH, and should record the arrangement in the agreement between the parties.

Insight 3: the binding to the manufacturing licence is weak, while the binding to import and distribution is strong. Sri Lanka does not, unlike Pakistan, write the eligibility of the applicant and the institutional licence into a tightly coupled provision; but the MAH in substance carries the responsibilities of the import and distribution stages, and for that reason it is typically the local importer or distributor. The practical consequence is that commercial relationships and regulatory accountability overlap: terminating a distribution agreement can unsettle the registration arrangement, and a registration held by an MAH that is also the exclusive distributor gives that partner leverage. Both facts should be considered when the appointment terms are drafted.

4. Practical recommendations

• When assisting a client to select an MAH, require the candidate to produce three things: the local commercial registration documents, a statement of staffing with regulatory affairs capability, and the response procedures for vigilance and recall.
• Treat a partner that performs distribution only, without vigilance capability, as a high-risk choice in Sri Lanka, because the MAH obligations expressly include quality incident handling and recall coordination.
• Put the allocation of vigilance collection and reporting duties in writing, so that the MAH can meet its statutory role and the manufacturer can meet its own obligations without duplication or gaps.
• Agree in advance on recall coordination and on the bearing of associated costs, so that an emergency does not become a negotiation.
• Establish the internal mechanism for notifying changes in the regulatory status of the product in other countries, and test it before the first submission rather than after the first incident.

5. Verification checklist

• □ A local Sri Lankan MAH has been designated.
• □ The MAH holds a valid local commercial registration.
• □ A Letter of Authorization (LOA) from the manufacturer has been signed.
• □ The division of vigilance collection and reporting duties has been agreed.
• □ An internal notification mechanism for changes in the regulatory status in other countries has been established.
• □ Recall coordination and the bearing of costs have been agreed.

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