Power of attorney requirements for EMB

1. Key takeaways

Article 11.9 of the technical regulation sets the statutory requirements for the power of attorney (poder de representación legal). The document must be issued by the product holder and must expressly state its period of validity and the powers conferred. Where the power of attorney is issued inside Costa Rica, it must comply with the Costa Rican Civil Code or the Commercial Code. Where it is issued abroad, it must state its period of validity, conform to the legal framework of the issuing country, identify who acts as the legal representative before the Ministry of Health and the powers conferred by the grantor, and it must be legalised by consular means or apostilled. If it is not in Spanish, an official translation must be attached, together with notarisation of the digital signature or processing under Decree DE 37988-S. Every one of these elements is mandatory; none is optional, and an incomplete poder is one of the most common reasons for file defects in Costa Rican dossiers.

2. Legal basis

The relevant provisions of RTCR 505:2022 cover the content of the power of attorney, the divergent treatment of domestic and foreign documents, and the three situations in which a new poder must be submitted after registration.

3. Expert insights

Insight 1: the validity period is treated as an indispensable element throughout the regulation. Article 11.9 lists the validity period among the mandatory contents of the poder, and the requirement recurs: Articles 10.3, 11.9 and 16.2 all demand that the power of attorney state its validity period. Article 16.2 goes one step further: if the power of attorney in the dossier has expired at renewal, a new one must be submitted. The meaning is that a poder without a stated validity period is not acceptable in Costa Rica, and a poder that has lapsed blocks both renewal and change filings. Note that this differs from the Article 10.15 rule under which an unstated validity period is treated as two years — that is a residual default rule, whereas the provisions just described are mandatory content requirements. Drafting on the default rule instead of stating the period is a mistake.

Insight 2: the four requirements for a foreign poder are cumulative. Article 11.9 strings them together with the word además: the document must state its validity period and the powers conferred, and in addition it must be legalised or apostilled, accompanied by an official translation if it is not in Spanish, and accompanied by notarisation of the digital signature or processed under DE 37988-S. All four must be satisfied, and legalisation and translation are handled independently of each other. This is the step where foreign holders most often leave something out — in particular, the requirement to follow the legal framework of the issuing country is frequently mistaken for a bare notarisation exercise. A document that is notarised but not apostilled, or apostilled but untranslated, fails.

Insight 3: the domestic/foreign split between the Civil Code and the Commercial Code depends on the nature of the parties. Article 11.9 applies the Civil Code or the Commercial Code to domestically issued powers of attorney, and the choice depends on the holder’s legal character and the nature of the act of representation: commercial agency falls under the Commercial Code, general civil agency under the Civil Code. Companies should determine which regime applies before execution rather than assume one covers both. Domestically issued powers of attorney must also be digitally signed by both parties’ legal representatives — the requirement for documents of the same form under Article 11.8.1 may be taken as a reference point.

Insight 4: the poder is re-required in three post-registration scenarios. Renewal (Article 16.2), change of legal representative (Article 18.4) and change of holder (Article 18.3.2) each trigger a fresh power of attorney. Article 18.4 treats the change of the holder’s legal representative as a distinct post-registration change whose only listed submission is the new poder; Article 18.3.2 requires, on a change of holder, a power of attorney addressed to the new holder’s representative. Together these provisions show that the power of attorney is the living credential of the holding structure: whenever the people or entities behind it change, the document must be refreshed. Treating it as a one-time registration attachment is a scheduling error.

4. Practical recommendations

• Issue the power of attorney from the product holder, expressly stating the validity period and the scope of powers; do not use undated, open-ended grants.
• Execute the foreign poder under the legal framework of the issuing country (for example notarisation or the equivalent local form), then obtain an apostille or consular legalisation.
• For non-Spanish documents, obtain an official translation and attach notarisation of the digital signature or process the signature under DE 37988-S.
• Track the poder’s validity in a register: before renewal, check under Article 16.2 whether it is still valid, and renew an expired document first.
• When personnel or entities change, submit the new power of attorney under Article 18.4 (change of legal representative) or Article 18.3.2 (change of holder) as applicable.

5. Verification checklist

• □ Power of attorney issued by the product holder (Article 11.9)
• □ Validity period and powers expressly stated (Article 11.9)
• □ Domestically issued documents processed under the Civil Code or Commercial Code (Article 11.9)
• □ Foreign documents executed under the issuing country’s framework and legalised
• □ Non-Spanish documents accompanied by official translation and digital signature notarisation
• □ Validity checked under Article 16.2 before renewal
• □ New powers of attorney filed under Articles 18.4 / 18.3.2 upon changes

Related reading: [The product holder (titular del producto) and the in-country legal representative](/costa-rica-medical-device-registration/product-holder-and-resident-legal-representative/) | [Five-year registration validity and the eleven renewal items](/costa-rica-medical-device-registration/five-year-validity-and-renewal-eleven-items/) | [Nineteen categories of post-registration changes and four notification items](/costa-rica-medical-device-registration/post-registration-changes-nineteen-categories/)

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