Separate Registration and New Registration Triggers

1. Key takeaways

Costa Rica has two start-over triggers that are easily mixed up, set out in Articles 10.8 and 10.9 on the one hand and Article 10.5 on the other: first, EMB that are similar but differ in composition must be registered separately; second, where a change of the specific use, that is the indication for use, alters the risk classification, a new registration is required. At the same time, Article 10.5 treats a product change that alters the risk classification as a new product, requiring a fresh application under Articles 11, 12 or 13. Distinguishing these two triggers, and distinguishing them from the post-registration change channel of Article 18, is the core of change management in Costa Rica.

2. Legal basis

The table below sets out the separate registration and new registration triggers alongside the change provisions that apply when the classification does not change.

3. Expert insights

Insight 1: Article 10.8 and Article 10.7 are neighbouring provisions and are complete only when read together. Article 10.7 permits seven forms of grouping, and Article 10.8 immediately afterwards provides that products differing in composition must be registered separately. This adjacent structure shows that the legislator deliberately drew a boundary while offering the grouping convenience: the legitimacy of grouping comes from identity of use and structure, and a difference in composition cuts grouping off directly. In practice, the judgement on whether products differ in composition should be made on the formulation and material composition, not on the product name or the model designation.

Insight 2: The division of labour between Article 10.5 and Article 10.9 is that the former governs product changes and the latter governs use changes, and the common threshold for both is a change of risk classification. The consequence of both is the same, re-registration; the difference lies in what triggers them. Conversely, where a change does not alter the classification, no new registration is triggered and the post-registration change route of Article 18 applies: packaging size movements go through Articles 10.6 and 18.10, and use extensions go through Article 18.14, although use extensions for Clase 3 and 4 still require clinical evidence to be submitted separately.

Insight 3: Article 18.14 reveals an intermediate zone that is easy to misjudge: a use extension is itself a change, but it can slide into re-registration. Article 18.14 permits use changes or extensions to be handled as post-registration changes, conditioned on submitting a medical specification that contains the new use, and for Clase 3 and 4 on submitting clinical evidence supporting the new use, pursuant to Article 12.2. But Article 10.9 simultaneously provides that a use change that alters the classification requires a new registration. The correct sequence is therefore to first assess, under Article 8.1 and Annex A, whether the new use changes the classification; if it does, take the re-registration route, and only if it does not take the Article 18.14 route.

Insight 4: The first sentence of Article 18 requires changes to be approved before implementation, which forces the assessment to happen up front. The source text reads that the applicant must tramitar su aprobación a la autoridad reguladora nacional previo a su implementación. Combined with Article 10.5, if a company implements a change without assessment and that change alters the classification, two consequences are triggered at once: implementing a change without approval under Article 18, and selling a new product without registration under Article 9, the latter falling into the serious infringement of Article 2, item II.b) of the approving decree.

4. Practical recommendations

• Establish a change assessment checklist: for any movement in formulation, materials, structure or use, first determine whether it alters the risk classification under Article 8.1.
• Register products with different compositions separately under Article 10.8, and do not merge them under the name of a family or system.
• Plan changes that alter the classification directly as new registrations under Articles 11, 12 or 13, and do not route them through the Article 18 change channel.
• Handle use extensions that do not alter the classification under Article 18.14, and prepare the corresponding clinical evidence by class, mandatory for Clase 3 and 4.
• Complete the filing of all changes before implementation as required by the first sentence of Article 18, and treat implementing changes before approval as an internal red line.

5. Verification checklist

• □ Assessed whether each change alters the risk classification (Articles 8.1, 10.5 and 10.9)
• □ Products with different compositions registered separately (Article 10.8)
• □ Changes that alter the classification planned as new registrations (Articles 11, 12 or 13)
• □ Use extensions that do not alter the classification prepared under Article 18.14
• □ Clinical evidence prepared for Clase 3 and 4 use extensions (Article 12.2)
• □ All changes filed before implementation (first sentence of Article 18)

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