Unclassified Devices: Classification by Administrative Resolution

1. Key takeaways

Costa Rica classifies EMB into four risk classes under Article 8.1 and the Annex A rules, and those rules cannot describe every technology that reaches the market. Article 8.3 of the main regulation therefore provides: for products whose characteristics are not described in the classification rules, the Ministry of Health determines their class by administrative resolution (resolución administrativa), and these resolutions must be incorporated into the regulation (las cuales tendrán que incorporarse al Reglamento). This is the fallback mechanism of the Annex A rule system and the dynamic expansion point of the Costa Rican classification system — the classification of new technologies does not wait for a legislative amendment, but accumulates through case-by-case resolutions that are then incorporated into the regulation. Once a resolution is issued, it becomes part of the regulatory framework against which later, similar products are judged.

• Article 8.3 classifies rule-uncovered products by administrative resolution of the Ministry of Health.
• Resolutions must be incorporated into the regulation, making them citable precedents.
• Article 8.3 is company-initiated; Article 22.2 is a Ministry-initiated review power — two different channels.
• The class assigned determines the dossier tier and therefore the cost of registration.
• Weak product descriptions in a resolution application risk later reversal and re-registration under Article 10.5.

2. Legal basis

The provisions below reproduce the administrative-resolution mechanism and the neighbouring articles that give it effect within the classification system.

3. Expert insights

Insight one: Articles 8.3 and 22.2 are two channels running in different directions and are often confused. Article 8.3 resolves gaps in the rules — the product’s characteristics have no corresponding description in Annex A — and is a forward-looking classification need, initiated by the company, with the Ministry of Health determining the class by resolution. Article 22.2 resolves challenges to a classification — the product has already been imported or sold as Clase 1 and the Ministry of Health considers it does not belong to that class — and is a backward-looking review power. The former is initiated by the company and the latter by the Ministry of Health; the conclusion of the former must be incorporated into the regulation, while the conclusion of the latter binds the individual case directly.

Insight two: the half-sentence on incorporation into the regulation determines the visibility and citability of resolutions. The original wording of Article 8.3 is “las cuales tendrán que incorporarse al Reglamento”. The meaning is that such classification resolutions are not internal opinions effective only for the individual case but are to be brought into the regulatory system. Companies handling similar products can therefore cite existing resolutions as a basis for their determination; it also means that once a resolution is issued for a category, the room for self-determination for the same category narrows.

Insight three: the classification outcome directly determines the dossier tier and the cost of registration. A Clase 2 outcome requires the dossier of Article 11 with its eleven items; a Clase 3 outcome adds the six clinical evidence items of Article 12.2; a Clase 4 outcome adds the three items of Articles 13.1.1–13.1.3 (risk analysis, post-market literature, and animal-source biosafety certificates). The product characteristic description and intended-use statement submitted with the resolution application therefore effectively set the company’s own dossier burden and should be drafted carefully to the evidence standard of Clase 3 and above. Weakening the description to lower the threshold risks reversal in later verification, which would trigger re-registration as a new product under Article 10.5.

Insight four: the mechanism lets Costa Rica absorb new technologies quickly, but it also creates uncertainty. Compared with systems that must amend the law to add new classes, classification by administrative resolution responds faster. For companies, however, a new category cannot be read out of the regulatory text on first entry, and a resolution must be obtained first. Timelines should list this step as a separate upstream milestone rather than assuming it can be solved in parallel at submission; because the timing of the resolution is outside the company’s control, the waiting period must be absorbed in the schedule rather than assumed away.

4. Practical recommendations

• Where applying the Annex A rules to a new product leaves interpretive room under more than three rules, apply directly for an administrative resolution under Article 8.3 instead of improvising with the nearest rule.
• Draft the product characteristics and intended use in the application to the evidence standard of Clase 3 and above, keeping them consistent with the labelling, technical specifications and medical specifications.
• Maintain a resolution register recording the resolution number, date, product description and classification outcome, as the citable basis for similar products.
• Configure the dossier only after the classification outcome is issued, to avoid rework from preparing to a pre-judged tier.
• If the Ministry of Health raises a classification challenge during verification (Article 22.2), respond using the resolution register and the written classification reasons.

5. Verification checklist

• □ Confirmed that the product’s characteristics have no corresponding description in Annex A
• □ Administrative-resolution classification application submitted under Article 8.3
• □ Product description in the application consistent with labelling, technical specifications and medical specifications
• □ Resolution register maintained (number, date, outcome)
• □ Dossier configured only after the classification outcome is issued
• □ Response plan prepared for an Article 22.2 classification challenge

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