Advertising, Promotion and Donation Boundaries

1. Key takeaways

Costa Rica imposes three layers of constraint on the market conduct for devices. Advertising must comply with the current version of the Sanitary Regulation on the Authorisation and Control of Advertising of Products of Health Interest (Article 20). Donations are expressly brought within the scope of the principal regulation (Article 2.1.6), yet donated EMBs that have not been approved by the Ministry of Health in accordance with the requirements and procedures of the principal regulation are prohibited from use for any purpose (Article 24.4). In addition, Article 2 of the approving decree lists as minor or serious infringements respectively: advertising unregistered products, misleading advertising, creating false expectations, claiming substitution for professional diagnosis or treatment, promoting professional-use products to the public, and selling unregistered or prohibited products by mail order or online.

• Advertising is governed by a dedicated advertising regulation in its current version, to which Article 20 points, not by the device registration framework itself.
• Donation is both a scope item and a prohibition: it sits inside the regulation, and unapproved donated devices cannot be used at all.
• Advertising-related infringements occupy six items in Article 2 of the approving decree, a higher density than any other type of conduct.
• The remote selling clause (Article 2 II.m) brings e-commerce and mail order squarely into scope, covering both unregistered products and products on the prohibited list.
• Professional-use products must be promoted only to professional audiences, never to the general public.

2. Legal basis

The advertising and donation regime combines the technical regulation RTCR 505:2022 — which fixes scope and the approval requirement for donations — with the conduct prohibitions of Article 2 of the approving decree Decreto Ejecutivo N° 43902-S. The provisions relied on in this volume are listed below.

3. Expert insights

Insight one: Article 20 is a pointing clause that outsources the advertising rules to a separate dedicated regulation. The original wording is La publicidad… deberá atender las disposiciones establecidas en el Reglamento para la autorización y control sanitario de la publicidad de productos de interés sanitario en su versión vigente. The meaning is that advertising in Costa Rica must comply with the dedicated advertising regulation, and specifically its current version. Before launching any campaign, a company must confirm the current version of that regulation rather than importing assumptions from the device registration framework.

Insight two: Donations are written into both the scope of application and the prohibition clause, forming an independent channel that requires approval. Article 2.1.6 brings donations under the principal regulation; Article 24.4 prohibits the use for any purpose of donated EMBs not approved by the Ministry of Health. Definitions 4.13 and 4.14 constrain eligibility on both sides: the donor must be legally established in its own country, and the recipient must be the head or legal representative of a public institution, non-governmental organisation or non-profit association legally established in Costa Rica, responsible for the use of the products in the country. The meaning is that donation is not an exemption but another channel that requires approval.

Insight three: Advertising infringements account for six items in Article 2 of the approving decree, a density higher than any other type of conduct. The minor item I.c) covers advertising unregistered products; the serious items are II.g) (advertising that misleads consumers or departs from the approved specifications and uses), II.h) (creating false expectations of success or guaranteeing long-term use without adverse consequences), II.i) (claiming that use removes the need for professional or surgical care), II.l) (promoting professional-use products to the public) and II.m) (mail order or online sale of unregistered or prohibited products). This density shows that Costa Rica treats the promotion stage of a device as a regulatory target as important as the product itself.

Insight four: The remote selling clause of Article 2 II.m) brings e-commerce and mail order under supervision. The provision prohibits selling to the public, by correspondence or by remote means (por correspondencia o por procedimientos telemáticos), products that lack the corresponding registration, or products on the prohibited list. The meaning is that cross-border e-commerce, direct sales through official websites and social commerce are all within range, and that unregistered and prohibited-list status are stated side by side. For companies testing the market through online channels, this is an explicit red line.

4. Practical recommendations

• Obtain the current version of the advertising regulation for products of health interest before releasing any advertising material and review against it, without conflating it with product registration.
• Do not advertise in any form before registration is obtained, including online pages and exhibition materials (item I.c).
• Confine promotional content strictly to the approved specifications and uses, with no efficacy guarantees and no claims of substituting professional diagnosis or treatment (items II.g, II.h and II.i).
• Promote professional-use products only to professional audiences and never to the general public (item II.l).
• Route donation projects through the approval channel of Article 24.4: confirm that the recipient meets the eligibility of definition 4.14, and do not use the products before approval.

5. Verification checklist

• □ Advertising has been reviewed against the current version of the advertising regulation (Article 20)
• □ No advertising exposure exists for unregistered products (I.c)
• □ Promotional content stays within the approved specifications and uses (II.g)
• □ No efficacy guarantees or substitution claims have been made (II.h and II.i)
• □ Professional-use products have not been promoted to the public (II.l)
• □ All products sold online are registered and not on the prohibited list (II.m)
• □ Donation projects have been approved under Article 24.4 with eligible recipients

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Costa Rican market. Our team manages Ministry of Health (Ministerio de Salud) sanitary registration applications, prepares Spanish-language dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com