Foreign Documents: Apostille, Consular Legalisation and Notarial Certification

1. Key takeaways

Article 10.17 of the main regulation provides that all official or legal documents issued abroad must undergo consular legalisation (legalización) or apostille (apostilla) in accordance with the specific rules of each country, and must be accompanied by the notarial certification of the digital signature or processed under DE 37988-S. Article 10.15 adds two validity rules: an official document or certificate is valid only if it is within its validity period at the time of submission; and where the document does not state a validity period, it is deemed valid for 2 years from the date of issue. Article 10.16 further provides that submitted documents must not bear alterations, unless corroborated by the original issuing authority.

• The choice between apostille and consular legalisation follows the issuing country’s treaty status, not a Costa Rican designation.
• mainland China has applied the Hague Convention since November 2023, so mainland-issued public documents take the apostille route.
• The two-year default validity of Article 10.15 bites hardest on the CLV and the BPM certificate, which rarely state a validity period.
• Article 10.14 gives all submitted dossier content the character of a sworn declaration and requires internal consistency across documents.
• Article 10.18 offers a parallel digital route: a notarially certified copy where the certificate is in the authority’s database.

2. Legal basis

The formalities for foreign documents combine the core provision of Article 10.17 with the validity, alteration and consistency rules around it, as set out below.

3. Expert insights

Insight 1. Article 10.17 uses the wording según la normativa específica de cada país — according to the specific rules of each country — meaning that Hague Convention member states use the apostilla and non-member states use legalización. The choice is thus handed to the issuing country’s international obligations rather than fixed uniformly by Costa Rica. mainland China has applied the Convention Abolishing the Requirement of Legalisation for Foreign Public Documents (the Hague Convention) since November 2023, so public documents issued from mainland China should be processed by apostille (apostilla). Companies should first confirm the treaty status of the issuing country when planning the formalities.

Insight 2. The two-year default validity of Article 10.15 is a backstop rule, and it affects the CLV and the BPM certificate most. The text reads en los casos que no se indique la vigencia, esta será de 2 años a partir de la fecha de emisión. The CLVs issued by most countries do not state a validity period, so in Costa Rica they are deemed valid for 2 years from the date of issue. This means that a CLV obtained two years ago is already invalid at submission and must be obtained again. This is the time cost most often underestimated in project scheduling.

Insight 3. Article 10.14 gives the submitted documents as a whole the character of a sworn declaration — a responsibility clause. The text reads todo lo señalado en los documentos presentados tendr carácter de declaración jurada, además toda la información debe ser coincidente. It carries two layers: first, the truthfulness of the document content is borne by the applicant under oath; second, the information in all documents across the dossier must be mutually consistent. The second layer is the one most easily lost in practice — a product name or code written differently on the CLV, the label, the technical specifications and the application form is taken directly as an inconsistency.

Insight 4. The no-alteration rule of Article 10.16 and the digital-copy channel of Article 10.18 complement each other. Article 10.16 prohibits alterations to submitted documents unless corroborated by the original issuing authority; Article 10.18 allows, where the document can be found in the competent authority’s database, submission of a notarially certified copy of the digital document. The latter gives electronic documents a compliant path, while the former preserves the integrity of paper documents. Together the two provisions define the acceptable document forms.

4. Practical recommendations

• Determine first, by issuing country, whether apostille or consular legalisation applies; documents issued from mainland China take the apostille route from November 2023 onwards.
• Keep a document validity ledger: official documents without a stated validity period run for 2 years from the date of issue (10.15), with the CLV and BPM certificate monitored closely.
• Before submission, check each document for alterations; where a correction is genuinely needed, have the original issuing authority reissue or corroborate it (10.16).
• Unify the writing of product names and codes across the CLV, labels, technical specifications and the application form, and run the consistency check under Article 10.14.
• After legalising foreign documents, process the notarial certification of the digital signature separately or use the DE 37988-S route (10.17); the two layers are not merged.

5. Verification checklist

• □ Apostille or consular legalisation confirmed by issuing country (10.17)
• □ Documents without a stated validity period checked against the two-year rule (10.15)
• □ Documents free of alterations, or corroborated by the original authority (10.16)
• □ Dossier-wide information consistency checked under Article 10.14
• □ Notarial certification of the digital signature or the DE 37988-S route completed (10.17)
• □ Digital-copy notarial certification channel of Article 10.18 evaluated

Related reading: [Spanish language requirements and the scope of official translation](/costa-rica-medical-device-registration/spanish-language-and-official-translation/) | [Multi-country CLV issuance: Article 4.7 of the 2024 amendment](/costa-rica-medical-device-registration/certificate-of-free-sale-multi-country-issuance/) | [BPM certificate and the deferral effect of Transitorio I](/costa-rica-medical-device-registration/bpm-certificate-and-transitorio-i-deferral/)

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