Infringements three tiers and four prohibitions

1. Key takeaways

Costa Rican infringement law for EMB distinguishes three tiers totalling 18 items, set out in Article 2 of the approving decree. Minor (Leves), 3 items: exhibiting unregistered products at trade fairs; obstructing inspection work; advertising unregistered products. Serious (Graves), 13 items: manufacturing, assembling or sterilising in the country without the corresponding permit; failing to fulfil registration, renewal or change obligations; distributing or selling in unauthorised premises; selling or promoting the product for uses outside the registration; selling deteriorated or expired products; obstructing inspectors; misleading advertising or creating false expectations; claiming the product can replace professional diagnosis or treatment; use by professionals beyond their scope of practice; use by unqualified persons; advertising professional-use products to the general public; and mail-order or internet sales of unregistered products or products on the prohibited list. Extremely serious (Muy Graves), 2 items: selling an EMB that endangers health or safety; selling a counterfeit EMB. Article 24 of the technical regulation adds four prohibitions: certain self-test IVDs may not be sold to the public; products made from human tissue may not be registered; menstrual cups labelled for continuous use beyond 8 hours may not be sold; and donated EMB not approved by the Ministry may not be used for any purpose.

2. Legal basis

The table below maps the three infringement tiers of the approving decree and the four prohibitions of the technical regulation.

3. Expert insights

Insight 1: Article 2, II.m) of the approving decree cites numeral 26 of the regulation, but the prohibitions sit in Article 24 — the second cross-reference inconsistency in the official text. The wording of item II.m) refers to products included in the prohibition according to the numeral 26 of this reglamento. The technical regulation has 25 articles in total; Article 24 is the prohibitions (PROHIBICIONES) and Article 25 is the bibliography. The practical handling is to follow the four prohibitions of Article 24 as authoritative and to flag the inconsistent citation in internal compliance manuals, so that no one wastes effort searching for a nonexistent Article 26 or, worse, concludes the prohibition is unenforceable because of a drafting error.

Insight 2: the dividing line between minor and serious lies in whether the product has entered circulation and whether supervision is obstructed. The three minor items share one feature: the sale has not yet been completed. Exhibition at a fair (a) and advertising of unregistered products (c) occur before the transaction, while obstructing inspection (b) is a procedural interference. In the thirteen serious items, by contrast, anything involving manufacture, distribution, sale or promotion is escalated to the serious tier. The implication for companies is that any public exposure of an unregistered product — trade fairs, promotional materials, e-commerce pages — is already on the infringement list. Waiting until the product is actually sold before treating exposure as a risk is the wrong reading of the tiers.

Insight 3: Article 24.1 bans the channel of public sale of personal self-test IVDs, not the product category itself. The provision is confined to IVDs that are not authorised by the Ministry of Health for sale to the public — the prohibition targets the public retail channel, while the product itself is not barred from registration or import. Read with Annex A Rule 6: personal self-test IVDs are generally Class 3, while self-tests for pregnancy, fertility and cholesterol are Class 2. The meaning is that such products can still be registered, but they may only move through professional channels and must not be retailed directly to the public. Channel design must be fixed before launch, not corrected after a first retail sale.

Insight 4: the 8-hour figure in Article 24.3 is one of the rare quantified prohibitions in the regulation. The provision prohibits registering or selling menstrual cups labelled for continuous use beyond 8 hours. This is a compliance red line that can be verified directly: if the use-duration statement on the product label or instructions exceeds 8 hours, the product falls within the prohibition. Companies designing labels and instructions for this product category must treat this number as a hard check item during artwork review, along with any indirect claims suggesting longer wear.

4. Practical recommendations

• Run internal compliance reviews against the three-tier list: minor items watch for exposure before registration; serious items watch the full manufacture, sale and promotion chain; extremely serious items watch safety and authenticity.
• Move exposure management forward: before registration is obtained, no trade fairs, no advertising, no e-commerce pages (Leves items a and c).
• Route personal self-test IVDs exclusively through professional channels under Article 24.1; do not retail them to the public.
• Check menstrual cup labelling and instructions for the continuous use duration and keep it at or below 8 hours (Article 24.3).
• Run donation projects through the approval channel under Articles 24.4 and 2.1.6; do not use donated EMB before approval.
• Flag in the compliance manual the inconsistent reference in Article 2, II.m) to numeral 26, and apply Article 24 as authoritative.

5. Verification checklist

• □ Internal review completed against the three-tier list (3 / 13 / 2 items)
• □ Trade fair, advertising and e-commerce exposure of unregistered products blocked
• □ Personal self-test IVDs confined to professional channels (Article 24.1)
• □ Human-tissue products excluded under Article 24.2 (IVD control reagents excepted)
• □ Menstrual cup use duration verified at no more than 8 hours (Article 24.3)
• □ Donation projects routed through the approval channel (Article 24.4)
• □ Cross-reference inconsistency of Article 2, II.m) flagged (authoritative provision is Article 24)

Related reading: [The sanctions ladder: market withdrawal, suspension and immediate cancellation](/costa-rica-medical-device-registration/sanctions-withdrawal-suspension-and-cancellation/) | [Compliance boundaries for advertising, promotion and donation](/costa-rica-medical-device-registration/advertising-promotion-and-donation-boundaries/) | [Class 1 exempt from registration but not from obligations: Article 2.4](/costa-rica-medical-device-registration/class-1-exempt-from-registration/)

Regulatory information verified as of October 29, 2026.

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