Three-Tier Alternative Evidence When the CLV Lacks Product Identification Codes

1. Key takeaways

Article 10.19 of the main regulation requires the CLV and the dossier documents to state clearly the manufacturer’s name, the product name and the identification code; where the identification code has not yet been obtained, the model must be stated and each device or material to be registered must be described in detail one by one. Where the competent authority of the exporting country does not include codes in the CLV, the regulation provides a three-tier alternative path: first tier, a list issued by the manufacturer or the holder and endorsed by the health authority (10.19); second tier, where the authority neither issues codes nor endorses the list, a letter from that authority explaining that its CLV does not contain this information (10.21); third tier, a letter issued by the holder or the legal representative quoting the extract of that country’s regulation proving that the requirement is genuinely not issued, with the regulatory source attached for verification (10.22).

• The three tiers are sequential fallbacks, not three freely interchangeable options.
• The first tier stands or falls on the endorsement (aval) of the exporting country’s health authority.
• The third tier requires the quoted regulatory extract plus a verifiable source, not a mere declaration.
• Products without an identification code must state the model and describe each item individually.
• Article 10.18 opens a parallel digital route: a notarially certified copy of the digital document where the certificate is in the authority’s database.

2. Legal basis

The three-tier mechanism is built from Articles 10.19, 10.21 and 10.22, supported by the digital-copy route of Article 10.18 and the definition of the product identification code.

3. Expert insights

Insight 1. The three-tier alternative is a step-down structure, not a menu of three freely selectable options. The first tier is the least burdensome (manufacturer’s list plus health authority endorsement), the second comes next (a letter from the authority explaining that it does not issue codes), and the third is the heaviest (the country’s regulation must be quoted and it must be proven that the requirement is genuinely not issued). The tiers apply in order of availability, and a company should pursue the first tier first and move down only when it cannot be obtained. Treating the third tier as the default choice amounts to voluntarily increasing the evidentiary burden.

Insight 2. The key to the first tier is the phrase con el aval de la autoridad sanitaria — with the endorsement of the health authority. The Spanish text reads se aceptará anexar el listado de los mismos emitido por el fabricante o el titular del producto con el aval de la autoridad sanitaria. The meaning is that a list issued by the manufacturer alone is not enough; the list must carry the endorsement of the exporting country’s health authority, in the form of a signature, a stamp or a countersignature. This point determines whether the first tier can be established at all.

Insight 3. The third tier requires the quoted regulation plus the source — a verifiability requirement. The Spanish text reads una carta emitida por el titular del producto o su representante legal en la que se incluya el extracto de la regulación que demuestre claramente que el requisito correspondiente no se emite y la referencia de dicha normativa para su verificación. The meaning is that it is not enough to declare that the country does not issue product codes; the letter must quote the specific provisions of that country’s regulation and give a regulatory source that can be checked. This requirement is expressly listed as one of the new facilitation measures in the CONSIDERANDO of the decree approving the main regulation.

Insight 4. Article 10.18 opens a separate digital facilitation channel for the CLV and the BPM certificate. Under that provision, where the CLV or BPM certificate can be found in the competent authority’s database, a notarially certified copy of the digital document (certificación notarial de copia del documento digital) may be submitted. This is a facilitation measure running in parallel with the three tiers, suitable where the exporting country maintains a public database that can be verified online.

4. Practical recommendations

• Where the CLV does not list codes, first pursue the first tier: obtain the exporting country health authority’s endorsement (aval) of the manufacturer’s list.
• Where the authority does not endorse the list, move to the second tier and obtain the authority’s letter stating that its CLV does not contain product codes.
• Where neither is available, issue the holder’s letter under the third tier, quoting the regulatory provisions of that country and giving a verifiable source.
• Where the exporting country maintains a public database, evaluate the notarially certified digital-copy channel of Article 10.18.
• For products without an identification code, state the model and describe each unit in detail under Article 10.19, leaving no blanks.

5. Verification checklist

• □ CLV states the manufacturer, product name and identification code (10.19)
• □ Products without a code: model and detailed description given (10.19)
• □ Authority’s endorsement of the list pursued (first tier)
• □ Where unavailable, authority’s letter obtained (second tier, 10.21)
• □ Where still unavailable, regulatory-extract letter issued (third tier, 10.22)
• □ Digital-copy notarial certification channel of Article 10.18 evaluated

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/) | [BPM certificate and the deferral effect of Transitorio I](/costa-rica-medical-device-registration/bpm-certificate-and-transitorio-i-deferral/) | [Legalisation, apostille and the two-year default validity of foreign documents](/costa-rica-medical-device-registration/foreign-documents-apostille-and-notarial-certification/)

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