Labelling Eighteen Mandatory Items

1. Key takeaways

Article 19.1 of the principal regulation lists the 18 mandatory items of label content (19.1.1 to 19.1.18): the EMB name (which must reflect its true nature and be specific rather than generic); the use or intended use; the name, trade name or mark of the holder and its country; the name, trade name or mark of the manufacturer and its country; the product identification code (or, where there is no code, the model stated in the registration); the batch number; a description of the contents of the commercial packaging; the expiry date or useful life; the sterile statement (if declared by the manufacturer); special storage and transport conditions; symbols and warning statements; instructions for use or a pointer to their location; whether the product is for personal use; whether it is single-use; the marking producto a la medida for custom-made devices; a specific warning statement for self-testing IVDs; the EMB registration number (not applicable to products exempt from registration); and a specific warning statement for research-use-only IVDs. The label must be the manufacturer’s original and the information must be in Spanish.

• The 18 mandatory items are enumerated individually in Article 19.1, from the product name through the registration number.
• Two statutory warning texts exist in Spanish for self-testing IVDs and research-use-only IVDs, and both must be printed in a visible and indelible manner.
• The registration number requirement carries its own exemption for products exonerated from registration, closing the loop with Article 2.4 for Clase 1.
• Where packaging space is insufficient, the instructions for use may be supplied separately, and instructions and manuals must be in Spanish.
• Cross-reference note: Article 11.7 points to numeral 21 rather than Article 19, an internal inconsistency in the official text handled by checking content against the 18 items of Article 19.1.

2. Legal basis

The labelling regime is set out entirely within the technical regulation RTCR 505:2022, principally in Article 19, with the supporting procedural rule for instructions and manuals. Each item of Article 19.1 carries its own numbering, which is reproduced below together with its requirement.

3. Expert insights

Insight one: The name requirement in Article 19.1.1 — reflect the true nature, specific and not generic — is a standard that can be judged directly on the face of the label. The original wording is Debe indicar la verdadera naturaleza del EMB, debe ser específico y no genérico. The meaning is that generic names such as catheter or reagent do not satisfy the requirement; the specific nature of the product must be stated. The provision also permits additional statements, trade names or trademarks to appear — that is, a brand name is allowed, but a brand name alone is not enough.

Insight two: The two warning texts of Articles 19.1.16 and 19.1.18 are the only two statutory verbatim sentences in Costa Rican labelling. The first targets self-testing IVDs: Esta prueba de autocontrol es únicamente orientadora y no brinda un diagnóstico definitivo (this self-test is indicative only and does not provide a definitive diagnosis); the second targets research-use-only IVDs: Esta prueba es de uso exclusivo para investigación. Este producto no está aprobado con fines diagnósticos ni terapéuticos, quedando su utilización bajo la entera responsabilidad de quien lo utilice. Both must be applied in a visible and indelible (visible e indeleble) manner — this is not only a content requirement but also a printing process requirement.

Insight three: The registration number requirement of Article 19.1.17 carries its own exemption clause, forming a closed loop with Article 2.4 of the principal regulation. The original wording is Número de Registro del EMB; este requisito no aplica para productos exonerados de registro conforme a las disposiciones del presente reglamento. This is the second place within the principal regulation that expressly mentions products exempt from registration (the first is Article 2.4). The meaning is that a Clase 1 product whose label omits the registration number is not in breach, but the remaining 17 items must still be complete.

Insight four: Article 11.7 lists the label among the registration dossier items, but its cross-reference reads numeral 21 rather than Article 19. This is an internal citation inconsistency in the official text of RTCR 505:2022 (Article 21 is the technovigilance article). The practical handling: supplementary label content should always be checked against the 18 items of Article 19.1, and the substantive provision relied on should be noted in the dossier, so that a reviewer raising an objection on the literal citation can be answered on substance.

4. Practical recommendations

• Build a label checklist item by item against 19.1.1 to 19.1.18, marking each item as included, or not applicable with a reason.
• Write the name so that it states the true nature of the product, and do not substitute a generic name or a bare brand name (Article 19.1.1).
• Apply the statutory verbatim warnings for self-testing and research-use-only IVDs under Articles 19.1.16 and 19.1.18, printed in a visible and indelible manner.
• For Clase 1 products, omit the registration number under the Article 19.1.17 exemption, but still verify the remaining 17 items one by one.
• Provide instructions and manuals in Spanish directly under Article 19.3; where packaging space is insufficient, supply them with the product under Article 19.2.

5. Verification checklist

• □ The label is the manufacturer’s original and the information is in Spanish (Article 19.1)
• □ All 18 items have been checked one by one and the checklist retained
• □ The name reflects the true nature and is specific (Article 19.1.1)
• □ The identification code or model is stated (Article 19.1.5)
• □ Self-testing IVDs carry the first statutory warning text (Article 19.1.16)
• □ Research-use-only IVDs carry the second statutory warning text (Article 19.1.18)
• □ The Article 19.1.17 exemption has been correctly applied for Clase 1
• □ Instructions and manuals are available in Spanish (Article 19.3)

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