Class 2 Dossier: The Eleven Required Documents

1. Key takeaways

Clase 2 is the lowest tier in Costa Rica that requires registration but not clinical evidence. The dossier list is set out in Article 11 and comprises 11 categories: the application form (11.1); the operating licence for local manufacturers (11.2) or, for imported products, the CLV (11.3); the manufacturer’s original technical specifications and medical specification (11.4); the BPM certificate (11.5); authorisation for radiation sources (11.6); the label or supplementary label proposal (11.7); third-party manufacturing contracts (11.8); the power of attorney (11.9); payment of fees (11.10); and, applicable to IVDs only, the document on accuracy and precision standards (11.11). Within this, the technical specifications break down into 12 items (11.4.1 a to l), IVDs add 2 items (11.4.2), and the medical specification has 6 items (11.4.3 a to f).

2. Legal basis

Every dossier component for Clase 2 rests on a numbered provision of Article 11, supplemented by one transitional provision of the approving decree that suspends the BPM certificate requirement.

3. Expert insights

Insight 1: The 12 items of technical specification under Article 11.4.1 are the largest and most frequently returned part of a Clase 2 dossier. Item by item they are: a) detailed description of the product and its identification code; b) an image of each product; c) detailed instructions for use; d) a clear description of the component parts; e) the materials of each component; f) whether single use or reusable; g) whether sterile, and if sterile, the sterilisation method must be stated together with a validation report for that process; h) whether sterilisation before use is required and by which method; i) whether for personal use; j) conditions of use and maintenance; k) storage and transport conditions; l) for IVD reagents, solutions for cleaning or sterilisation require the safety data sheet (FDS) and a qualitative formulation. Items g and l are the most common deficiency points: sterile products missing the sterilisation process validation report, or reagents missing the FDS.

Insight 2: Article 11.5 requires the BPM certificate to cover one or more stages of the product life cycle, and Transitorio I has suspended that requirement. The source text of Article 11.5 requires the certificate to cover the sites of one or more stages, such as design and development, production, storage and transport, installation or technical support. However, Transitorio I of the approving decree states expressly that until the State issues the BPM regulation for EMB, the BPM certificates required by Articles 11.5, 16.5, 18.9.2, 18.11.1 and 18.16.3 are not mandatory; Transitorio IV requires the Ministry of Health to issue that regulation within 12 months of entry into force. This combination forms the suspended-effect problem treated in article 27 of this volume.

Insight 3: Article 11.7 contains an internal cross-reference inconsistency in the official text that deserves particular attention. The provision states that the supplementary label must contain the requirements listed in numeral 21, but the labelling provision of the main regulation is in fact Article 19, since Article 21 concerns technical vigilance. This is a citation error inside the official text of RTCR 505:2022. The practical treatment is to verify the contents of the supplementary label against the 18 items of Article 19.1 and to state that basis in the dossier, so that reviewers raising objections on the literal citation can be answered with the correct provision.

Insight 4: Article 11.11 is the only dossier item that applies exclusively to IVDs, and it points to international standards rather than local ones. The provision requires submission of a document indicating the international standards in which the accuracy and precision standards applicable to the EMB are found. This means an IVD applicant must identify concrete standard numbers, such as a specific ISO standard, rather than making a generic declaration of conformity with international practice.

4. Practical recommendations

• Draft the technical specifications item by item against Article 11.4.1 a to l, preparing the sterilisation process validation report for sterile products and the FDS with qualitative formulation for reagents at the same time.
• Complete the medical specification fully under Article 11.4.3 a to f: use and indications, indications, contraindications and adverse reactions for pharmacological components, precautions for use, patient instructions, possible complications, and contraindications.
• Prepare the additional items of Article 11.4.2 and the international standard identification document of Article 11.11 separately for IVD projects.
• Assess whether the BPM certificate must be submitted in light of Transitorio I; if it does, confirm that the certificate covers all sites for the relevant life cycle stages.
• Submit the original label under Article 11.7; where it is not in Spanish or information is missing, draft the supplementary label proposal against the 18 items of Article 19.1, noting the citation inconsistency in Article 11.7.

5. Verification checklist

• □ Application form completed on the Regístrelo portal and digitally signed (11.1)
• □ Domestic operating licence or import CLV prepared (11.2 and 11.3)
• □ Technical specifications drafted item by item, all 12 items (11.4.1)
• □ Medical specification completed in all 6 items (11.4.3)
• □ IVD additional items and international standard identification prepared (11.4.2 and 11.11)
• □ BPM certificate assessed under Transitorio I (11.5)
• □ Applicability of the radiation source authorisation confirmed (11.6)
• □ Label or supplementary label proposal checked against Article 19.1 (11.7)
• □ Third-party manufacturing contract with the 7 clauses prepared (11.8)
• □ Power of attorney and payment completed (11.9 and 11.10)

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