Declaration Letter When the CLV Omits the Product Holder Name

1. Key takeaways

Article 1 of the 2024 amending decree also rewrites Article 10.20 of the main regulation, dealing with the case where the CLV does not state the name of the product holder: where the holder and the manufacturer are subsidiaries or branches of the same parent company and the CLV does not identify the holder, a letter signed by the manufacturer or the parent company must be submitted, declaring who is the product holder within the meaning of the main regulation. Where the CLV is issued by the country of the holder’s subsidiary or of the subsidiary of the parent company, a letter signed by the legal representative of the parent company must be submitted, declaring that the subsidiary is legally incorporated in the issuing country. Letters issued abroad must be legalised or apostilled; if they are not in Spanish, an official translation must be attached, together with the notarial certification of the digital signature.

• The declaration letter under the first paragraph names the product holder when the CLV omits the name.
• The letter under the second paragraph, signed by the parent company’s legal representative, declares the subsidiary’s legal incorporation in the issuing country.
• Both letters may be required at once for a single CLV.
• Abroad-issued letters need legalisation or apostille, official translation if not in Spanish, and notarial certification of the digital signature.
• Definition 4.60 of the main regulation supplies the meaning of product holder (titular del producto).

2. Legal basis

Article 10.20, as amended, sets out two letter requirements and a three-layer formality requirement, which interlock with the general foreign-document rules as follows.

3. Expert insights

Insight 1. Article 10.20 solves a very specific but very frequent practical problem: the CLV names only the manufacturer, not the holder. In group supply structures, a CLV issued by the competent authority of the country of manufacture usually states only the manufacturer’s name, while the Costa Rican registration holder may be a different brand-owning company. Before the amendment this situation had no explicit solution; after it, the declaration letter route exists, and the rule identifies the manufacturer or the parent company as the entity that must issue the letter.

Insight 2. The issuing entities and the applicable situations of the two paragraphs differ, and they must not be conflated. The first paragraph covers the case of a CLV that omits the holder’s name: the letter is issued by the manufacturer or the parent company and its content is a declaration of who the holder is. The second paragraph covers the case of a CLV issued by the country of the subsidiary: the letter is signed by the legal representative of the parent company and its content is a declaration that the subsidiary is legally incorporated in the issuing country. Both letters may be needed simultaneously — where a CLV is both issued by a subsidiary’s country and omits the holder’s name, two letters must be submitted.

Insight 3. Article 10.20 and Article 4.7 express the same legal-incorporation condition in two places. The final sentence of Article 4.7 requires that the subsidiary be legally incorporated in the issuing country; the second paragraph of Article 10.20 then turns that requirement into a submittable document — the letter signed by the parent company’s legal representative. The meaning is that this condition is not proven by the company’s own assertion, but by a certified letter from the parent company.

Insight 4. The three formal layers for the declaration letter — legalisation or apostille, official translation, and notarial certification — are cumulative, not alternatives. The final paragraph reads debe estar legalizada o apostillada y con su traducción oficial cuando el idioma de origen no sea el español, acompañado de su respectiva certificación notarial firmada digitalmente. The three layers are, in sequence: consular legalisation or apostille of the foreign document, the official translation where the original is not Spanish, and the notarial certification of the digital signature (or processing under DE 37988-S). Missing any one layer leads to rejection at the formal screening stage.

4. Practical recommendations

• Where the CLV does not state the holder’s name, obtain the declaration letter from the manufacturer or the parent company under the first paragraph of Article 10.20.
• Where the CLV is issued by the country of a subsidiary, obtain in addition the letter signed by the parent company’s legal representative declaring the subsidiary’s legal incorporation, under the second paragraph.
• Where both letters are required, process legalisation or apostille for each separately and do not merge them.
• Have non-Spanish letters officially translated under Article 10.13, and do not use internal translations.
• Attach the notarial certification of the digital signature to each layer of documents, or process them under DE 37988-S (Article 10.17), and retain the processing receipts.

5. Verification checklist

• □ Determined whether the CLV states the holder’s name
• □ Where omitted, declaration letter from the manufacturer or parent company obtained (10.20 first paragraph)
• □ Where issued by a subsidiary’s country, letter from the parent company’s legal representative obtained (second paragraph)
• □ Foreign letters legalised or apostilled
• □ Non-Spanish letters officially translated
• □ Notarial certification of the digital signature attached (10.17)

Related reading: [Multi-country CLV issuance: Article 4.7 of the 2024 amendment](/costa-rica-medical-device-registration/certificate-of-free-sale-multi-country-issuance/) | [Legalisation, apostille and the two-year default validity of foreign documents](/costa-rica-medical-device-registration/foreign-documents-apostille-and-notarial-certification/) | [Product holder titular del producto and the resident legal representative](/costa-rica-medical-device-registration/product-holder-and-resident-legal-representative/)

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