Product holder and resident legal representative

1. Key takeaways

No local registration holder company is required. Article 10.3 of the technical regulation establishes the basic rule: the registration application form must be digitally signed by the product holder (titular del producto), by its legal representative, or by a person whom the legal representative has authorised. Critically, where the product holder does not reside in Costa Rica, a power of attorney (poder) must be used to appoint a legal representative who resides within the national territory. That power of attorney must conform to the legal framework of the country in which it is issued, and it must state who acts as the legal representative before the Ministry of Health and what powers have been conferred on that person. In practical terms, the underlying structure of the Costa Rican holding arrangement is therefore fixed: the product holder may be a foreign entity, but the legal representative must reside in Costa Rica. This is the foundational element of the licence-holder structure in the country, and every downstream obligation — signature of applications, receipt of official communications, submission of classification materials — hangs off it.

2. Legal basis

The following provisions of the technical regulation RTCR 505:2022 govern the holder structure and the role of the resident legal representative. They should be read together, because the responsibility provisions and the representation provisions interlock.

3. Expert insights

Insight 1: the separation between the responsible party and the contactable party is deliberate. The structure — holder abroad, legal representative in-country — interlocks with the responsibility-allocation provisions of the technical regulation. Article 6.1 defines the product holder as the party responsible for the EMB, requiring it to ensure that the product complies with safety and performance requirements; Article 6.2 requires the holder to hold objective evidence and to provide it when the authority asks. Articles 10.3, 22.2 and 11.9, by contrast, assign the role of being reachable, served with documents and able to submit materials within the country to the legal representative. The meaning is clear: substantive responsibility rests with the foreign holder, while procedural obligations rest with the resident legal representative. Companies should design their service agreements around this division rather than blurring the two roles.

Insight 2: the reference to the law of the issuing country is a choice-of-law rule. Article 10.3 requires the power of attorney to be granted conforme al marco normativo del país de emisión — in accordance with the legal framework of the country of issuance. This means that when the power of attorney is executed abroad, its formal validity is assessed under the law of the issuing country, not automatically under the Costa Rican Civil Code. At the same time, the provision requires three items to be stated in the document: who is the legal representative facing the Ministry of Health, the powers conferred by the grantor, and the period of validity. For powers of attorney issued inside Costa Rica, Article 11.9 instead requires compliance with the Costa Rican Civil Code or Commercial Code. Drafting the document according to the wrong framework is a classic avoidable defect.

Insight 3: the signature chain allows three levels of delegation. Article 10.3 reads: signed digitally by the product holder or its legal representative or by whom the legal representative authorises. The third level of delegation is easily overlooked, yet it is what allows the in-country team to designate a specific operational person to sign the application form. The precondition is that the power of attorney has already conferred that power of re-delegation on the legal representative — which is precisely why Article 10.3 requires the document to state the facultades de quien lo confiere, the powers of the person who grants it. Companies that omit re-delegation language from the poder lose this flexibility and must fall back on the legal representative signing everything personally.

Insight 4: Article 22.2 is the clearest evidence that the representative must handle official correspondence. Under that provision, where the Ministry of Health has reasonable grounds to doubt the classification of a Class 1 product, it may require the product holder or its legal representative in Costa Rica to submit materials so that the true classification can be determined. This confirms that the legal representative performs the in-country function of receiving official notifications and responding to them. When appointing a legal representative, companies should write this function explicitly into the power of attorney and into the service agreement, so that the representative is contractually obliged to pass on and answer official requests without delay.

4. Practical recommendations

• Fix the holding structure as a foreign product holder combined with a legal representative resident in Costa Rica; there is no need to incorporate a holder company in Costa Rica.
• Draft the power of attorney to state the three elements required by Articles 10.3 and 11.9: the identity of the legal representative, the powers conferred by the grantor, and the period of validity; also state expressly whether the power of re-delegation is included.
• Execute the foreign power of attorney under the legal framework of the issuing country, then obtain legalisation or an apostille, an official translation, and notarisation of the digital signature.
• Write the legal representative’s duties into the service agreement: receiving official notifications, answering classification reviews under Article 22.2, and safekeeping the dossier and objective evidence under Article 6.2.
• Maintain monitoring of the power of attorney’s validity, renew it before expiry, and file no applications during any period in which the document has lapsed.

5. Verification checklist

• □ Confirmed that the product holder may be a foreign entity (Article 10.3)
• □ Appointed a legal representative resident in Costa Rica (Article 10.3)
• □ Power of attorney states identity, powers and period of validity (Article 11.9)
• □ Foreign power of attorney executed under the issuing country’s framework and legalised
• □ Legal representative duties written into the agreement, including Article 22.2 responses
• □ Power of attorney validity included in the monitoring register

Related reading: [Statutory requirements for the poder and requirements for execution abroad](/costa-rica-medical-device-registration/power-of-attorney-requirements-for-emb/) | [Licensing and changes for importers and authorised distributors](/costa-rica-medical-device-registration/importer-and-authorised-distributors/) | [National verification and the Class 1 classification review power](/costa-rica-medical-device-registration/verification-and-class-reassessment-power/)

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