Medical Device Advertising Regulation by the NMRA Advertisement Committee

1. Key takeaways

Advertising and promotion of medical devices in Sri Lanka are regulated by the Advertisement Committee of NMRA, and this function sits under the Market Control Division. Like price control, advertising compliance falls within the statutory scope of authority of NMRA: in the objects clause of the founding legislation, advertising is named alongside registration, licensing, pricing, production and import. The significance is structural rather than cosmetic — the power to regulate promotional activity derives from the parent statute, not from administrative discretion, and it is administered by the same division that runs surveillance, recalls and GDP inspections.

For manufacturers, the advertising rules touch materials that are often prepared far from the regulatory function: sales decks, exhibition panels, distributor scripts and website copy. All of these are promotion in the ordinary sense of the word, and all of them remain inside the statutory scope once the product is marketed in Sri Lanka. This page summarises the published framework, draws out the practical consequences of its structure, and closes with a short checklist for keeping promotional material aligned with the registration under which the product was approved.

2. Legal basis

The advertising framework and its enforcement support, as published on the NMRA website and in the text of the Act, are set out below. The first three rows answer the questions of who reviews advertising, where the function is housed, and on what legal footing it rests.

3. Expert insights

Insight one: advertising regulation is written into the objects clause of the parent Act. This shows that advertising compliance is not a matter of industry self-discipline but a statutory regulatory item. The distinction determines how violations are treated: a breach of a self-regulatory code invites peer criticism, while a breach of a statutory duty exposes the company to the enforcement machinery created by the Act itself. Companies planning promotional campaigns in Sri Lanka should therefore treat the Advertisement Committee’s review as a legal gate, not as an optional courtesy, and should budget review time into any launch schedule just as they would for registration milestones. The objects clause also explains why price control and advertising control travel together in the same statute: both sit in the same enumerated list of regulatory objects.

Insight two: the Advertisement Committee sits under the Market Control Division, alongside recall, sampling and GDP inspection. This means that a single market surveillance exercise may simultaneously cover advertising compliance. An inspector following a batch through the distribution chain has every opportunity to observe how the product is being promoted: the claims on the packaging inserts, the materials displayed at the point of sale, the statements used by distributors. Because these functions share one division, information gathered in one context reaches the others naturally. Promotional materials should therefore be prepared on the assumption that they will be seen by the same team that inspects warehouses and traces batches, and under the same standards of evidence.

Insight three: the Inspection and Enforcement Division inspects and investigates the execution of the Act’s provisions. This signals that the handling of violations is backed by an independent enforcement capability, and is not a purely formal review. The existence of a dedicated enforcement division means that findings made by the Advertisement Committee or by market inspectors have a route to follow-up: investigation, and whatever measures the Act provides. For a company, the practical reading is that an advertisement cleared casually today can become the subject of an investigation later, with the file retained as evidence. The safest posture is to keep every released item traceable to a review decision, with the reviewer, the date and the reference documents recorded.

4. Practical recommendations

When GRZAN pre-reviews promotional materials for clients, the review is conducted against three references: the product name and intended use stated on the registration certificate, the content of the approved labelling and instructions for use, and the review position of the Advertisement Committee. Material is released only when all three align. Expanded indication statements — claims that go beyond the approved intended use — must be removed before the material enters Sri Lanka. The three-reference method is deliberately conservative: the certificate defines what may be claimed, the approved labelling shows how it is phrased, and the Committee’s position governs how it may be presented. Applied consistently, the method catches problems at the drafting stage, where correction costs the least.

Where a proposed claim cannot be anchored in all three, the claim is rewritten or dropped rather than argued. Approval records of this internal pre-review are retained so that, if a question arises during a later inspection, the company can show that each item was checked before release. Distributors should be bound by the same rule contractually, since materials they produce in their own name remain promotion of the registered product.

5. Verification checklist

• □ Promotional content does not exceed the intended use stated on the registration certificate
• □ Material wording is consistent with the approved labelling and instructions for use
• □ Internal pre-review has been completed against the Advertisement Committee’s position
• □ Expanded indication statements have been removed
• □ Approval records are retained and available for inspection

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