Seven Grouping Cases Under a Single Registration

1. Key takeaways

Article 10.7 of the main regulation permits products meeting any of seven listed situations to be registered under a single application, provided their specific use remains unchanged: multiple packaging sizes of the same product (10.7.1); different concentration dilutions of the same pure substance with an unchanged CAS number and unchanged hazard classification (10.7.2); test kits (10.7.3); the EMB family (10.7.4); the EMB group (10.7.5); the group of a family (10.7.6); and the system (10.7.7). The article states expressly that these situations are assigned only one registration number; that adding family members, system components, or modifying kit composition or combination afterwards requires a post-registration change application; and that one application means one payment. Taken together, these rules make grouping one of the few cost and efficiency levers that the regulation grants applicants voluntarily, and the quality of the grouping argument, not the number of documents, determines whether the lever can actually be used.

2. Legal basis

The provisions below cover the seven grouping situations, their limits, the single number and single payment rule, and the boundary drawn by separate registration. The definitions in Articles 4.37, 4.40 and 4.58 supply the vocabulary that the grouping situations rely on, so the dossier should use those defined terms consistently when describing family, group or system membership.

3. Expert insights

Insight 1: The precondition for grouping is siempre que su uso específico no varíe, provided the specific use does not vary, and this clause qualifies all seven situations. Whether the grouping is made in the name of a family, a group or a system, the members must share the same specific use. Placing products with different uses into one family application will be returned at the formal review stage, and if discovered after approval, it will also draw in the change procedure of Article 18.10 and the compliance risk under Article 3 of the approving decree.

Insight 2: Article 10.7.2 sets two technical hard conditions for dilutions, the most specific of the seven situations. Only where both the CAS number is unchanged and the hazard classification is unchanged can dilutions of the same pure substance at different concentrations be grouped. These two conditions can be verified directly from the chemical documentation and the safety data sheet (FDS), leaving no interpretive room, which makes them a reliable control point for managing grouping risk.

Insight 3: One registration number and one payment are two independent commitments, but both sit inside Article 10.7 and together form the core benefit of grouped filing. One number means that subsequent changes, renewal, vigilance and labelling management all pivot on that number. One payment means that grouping does not multiply official fees as the number of members grows. On the other side, Article 10.8 requires that products differing in composition be registered separately. This is the explicit boundary of grouping and the point most easily confused with the concept of a family. In practice, whether products are similar-but-different in composition should be judged from the formulation and material composition, not from the product name or model reference.

Insight 4: Article 10.10 gives test kits an additional convenience: approval of the kit is treated as authorisation of all of its reagents and items. The source text reads Si se autoriza un kit de prueba, se considera que todos sus reactivos o artículos fabricados por el fabricante del kit de prueba have been authorised, but its reach is limited to reagents or items manufactured by the kit manufacturer itself. Purchased-in components are not automatically covered by the approval. Companies assembling kits from third-party reagents should therefore map each component against its own authorisation status before relying on the kit approval to carry it.

4. Practical recommendations

• Before grouping, check each candidate against Articles 10.7.1 to 10.7.7 and write out the applicable situation plus a statement of consistency of use, kept in the dossier.
• For dilution grouping, verify the two hard conditions of CAS number and hazard classification under Article 10.7.2 and attach the safety data sheet as corroboration.
• Screen family members against the unchanged specific use red line; products with different uses must apply separately and never be merged into the same number.
• Register products with different compositions separately under Article 10.8, and do not evade this by invoking the family concept.
• After approval, handle added members or adjusted combinations as post-registration changes under Article 18.10, and do not extend the use of the same registration number unilaterally.

5. Verification checklist

• □ Applicable grouping situation determined against Articles 10.7.1 to 10.7.7
• □ Unchanged specific use of grouped members documented in writing
• □ CAS number and hazard classification verified for dilutions (Article 10.7.2)
• □ Products with different compositions registered separately (Article 10.8)
• □ Aware that grouping yields only one registration number (Article 10.7, second paragraph)
• □ Later additions or removals planned as post-registration changes under Article 18.10

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