Registration Required Before Marketing in Costa Rica

1. Key takeaways

Article 9 of the main regulation contains only two sentences, yet it sets the pre-market threshold for Costa Rica in unmistakably rigid terms: EMB subject to this regulation may be manufactured, imported, commercialised or distributed in the country only after they hold the respective sanitary registration (registro sanitario) and demonstrate compliance with the norms, requirements and quality standards applicable to them according to their nature. The only exception is Clase 1 under Article 2.4, which is exempt from sanitary registration but remains subject to import, labelling, advertising, vigilance and control obligations. Costa Rica therefore operates a rule of registration-first-for-everything-except-Clase-1, not a system in which some products are partially exempt.

2. Legal basis

The obligations and consequences below are drawn directly from the technical regulation and its approving decree, and each entry identifies the specific article on which it rests.

3. Expert insights

Insight 1: Article 9 uses the exclusive phrase sólo podrán, meaning may only, and leaves no buffer room whatsoever. The source text reads Todo EMB objeto de este reglamento sólo podrán ser fabricados, importados, comercializados o distribuidos en el país si poseen el registro sanitario respectivo. Four verbs, manufacture, import, commercialise and distribute, are covered without exception. The implication is that registration is required not only for selling but already at the import stage itself: under the combined effect of Article 2.1.2 and Article 9, there is no legal basis for shipping goods into a bonded warehouse first and completing registration afterwards.

Insight 2: What registration must demonstrate is compliance with the norms, requirements and quality standards applicable according to the nature of the product, not safety in some generic sense. Article 9 states that the EMB must demuestre que cumplió con las normas, exigencias y estándares de calidad que les sean aplicables según su naturaleza. This half-sentence ties the dossier contents to the nature of the product and is precisely the textual basis for the three separate requirement lists in Articles 11, 12 and 13 for Clase 2, Clase 3 and Clase 4. When preparing a dossier, companies should first determine the class and then assemble the documents for the corresponding tier, because the judgement on what applies according to the nature of the product belongs to the Ministry of Health.

Insight 3: The consequences of failing to register are graduated and can escalate step by step. Article 2, item II.b) of the approving decree lists failure to comply with the sanitary registration obligation, failure to comply with the renewal obligation, or failure to apply for authorisation of post-registration changes directly as serious infringements (Infracciones Graves). Article 3 then provides that in cases of serious infringement the Ministry of Health may order market withdrawal and suspend the registration, and where the infringement cannot be remedied, cancel the registration. Reading this chain in reverse reveals the source of enforcement power behind the registration obligation: not registering does not merely mean being unable to sell, it means that products already on the market can be ordered out of it.

Insight 4: Article 9 and Article 2.4 must be read together, otherwise two opposite errors follow. Reading Article 9 alone produces the conclusion that all devices require registration, which conflicts with Article 2.4; reading Article 2.4 alone produces the conclusion that Clase 1 is unregulated, which conflicts with the proviso inside Article 2.4 itself. The correct reading is that Article 9 reaches products subject to the main regulation that are not exempted by Article 2.4. This is also the interpretive approach followed in article 07 of this volume.

4. Practical recommendations

• Complete the classification determination before project launch: products determined as Clase 1 follow the registration-exempt path but must still honour the five retained obligations, while products in Clase 2 to 4 prepare registration dossiers under Articles 11, 12 or 13.
• Make completed registration a precondition for import shipment, and do not adopt arrangements in which goods are shipped first and the certificate is obtained later.
• Organise the dossier around the norms and standards applicable according to the nature of the product: state the classification conclusion and its reasoning first, then assemble documents for the corresponding tier, and avoid applying a generic template.
• Maintain a registration status ledger that tracks validity periods under Article 15, five years, and renewal windows, so the company does not fall into the serious infringement of Article 2, item II.b).
• If a marketed product is found to lack registration, complete the registration as quickly as possible and simultaneously assess whether the market withdrawal and suspension risk under Article 3 is triggered; do not continue selling silently.

5. Verification checklist

• □ Product classification determined (Clase 1 to Clase 4)
• □ For Clase 2 to 4, confirmed that registration must be obtained before import or sale (Article 9)
• □ For Clase 1, confirmed that registration is exempt but the five obligations still apply (Article 2.4)
• □ Dossier assembled for the corresponding tier (Articles 11, 12 or 13)
• □ Validity period and renewal window entered in the ledger (Article 15)
• □ Article 3 market withdrawal risk assessed for the scenario of missing registration

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