Combination Products Primary Action Rule

1. Key takeaways

Nicaragua splits drug-device combination products by the primary action. Where the primary action is pharmacological, the product is assessed through the pathway of Ley No. 292, the Ley de Medicamento y Farmacias. Where the device is the primary element and the drug plays an ancillary role, the product is registered under NTON 24001:2023, but the quality and safety of the drug component must in addition be verified by the Quality Control Laboratory Directorate of ANRS. The deciding provision is Article 11 of Chapter 5 of NTON 24001:2023, and the applicant cannot choose the pathway. One point must be flagged: Article 5.11 of the consultation draft of Adenda 2026-05 proposes to delete the primary-action test, and this volume treats the matter according to the status of the consultation draft.

2. Legal basis

The table below brings together the provisions that define combination devices, the split rule in Article 11, and the pending amendment that would restructure it.

3. Expert insights

Point 1: The primary action is the only dividing test, yet the provision sets out no method for making it. Article 11 of Chapter 5 states only the two outcome branches. It does not explain how the primary action is to be determined, and it does not require the applicant to submit an argument on the point in the dossier. The determination therefore rests with the reviewer. What the applicant can do is write the intended use precisely: the Uso Previsto field required by item 2, subparagraph e.i of Chapter 6 in the application form and the technical data sheet are the two most direct anchors; a vague formulation leaves the door open to classification on the drug pathway.

Point 2: Definition item 11 draws the notion of combination narrowly: the device must form a single product with the medicine and must be intended exclusively for use in that combination (destinado a ser utilizado exclusivamente en esta combinación). Medicines supplied alongside a device that can also be used on their own, such as co-packaging, do not fall within this definition. However, Article 11 of Chapter 5 provides no separate handling rule for that situation, which is a gap in the text; in practice the specific product should be confirmed in writing with the DDM.

Point 3: Where the device predominates the route is dual-track, not single-track. Beyond the NTON registration, the drug component must also pass the quality and safety verification of the Quality Control Laboratory Directorate (Dirección de Laboratorio de Control de Calidad) of ANRS. This is the only provision in the whole of NTON 24001:2023 that writes another technical directorate of ANRS into the device registration chain of obligations, and it is the reason the timeline for a combination product cannot be estimated as if it were an ordinary device.

Point 4: The 5.11 amended text of Adenda 2026-05 removes the primary action altogether. The two occurrences of si la función principal are deleted, replaced by la acción farmacológica following Ley 292 and la función del dispositivo médico following this standard, and the verification duty acquires the qualifier según aplique. If the consultation draft is finalised as it stands, pathway determination will shift from an either-or choice to handling by action separately, and verification may change from mandatory to conditional. The public consultation period stated in Circular ANRS-DDM-BRML-0002-06-2026 runs until 1 July 2026, and the final text governs once officially published.

Point 5: Article 11 of Chapter 5 mentions only fármaco, the drug, and does not cover biological products, materials of human or animal origin, or cell and tissue products. Combination products containing such components have no landing point in the current standard, and this provision must not be stretched to infer a pathway for them.

Point 6: The provision closes the loop with definition item 7. The closing part of item 7 already declares that a device does not achieve its principal intended action by pharmacological, immunological or metabolic means, although it may be assisted by them; Article 11 of Chapter 5 is precisely the operationalisation of that definition. Read together, the two confirm that the device boundary in Nicaragua follows the principal-action test, in wording consistent with item 7.

4. Practical recommendations

• Complete the primary-action determination at the project stage and keep a written record. The record should state the product composition, mechanism of action and intended use on which the determination rests, not merely the conclusion.
• Write the intended use into both the Uso Previsto field of the official application form and the technical data sheet, with identical wording in the two places; the technical data sheet must be in Spanish.
• Once the device pathway is confirmed, approach the Quality Control Laboratory Directorate of ANRS in advance to confirm the document list and timeline for the quality and safety verification of the drug component, and schedule that phase separately in the project plan rather than folding it into the registration review estimate.
• Products in a co-packaging configuration are not handled as combination devices under item 11: judge the applicable regime for the device and the medicine separately, and confirm that judgment in writing with the DDM.
• Products containing biological substances or materials of human or animal origin must not be fitted into Article 11 of Chapter 5; submit a separate written enquiry to the DDM and retain the reply.
• Keep a tracking record for Article 5.11 of Adenda 2026-05: the consultation period runs until 1 July 2026, and once finalised the pathway determination and verification duties for combination products must be reassessed.

5. Verification checklist

• □ A description of the product composition has been obtained, confirming whether the device and the medicine form a single product intended exclusively for that combination (item 11)
• □ It has been determined in writing whether the primary action is pharmacological or a device action, and the basis retained
• □ The current text of Chapter 5 Article 11 has been compared with the 5.11 amended text of the Adenda 2026-05 consultation draft
• □ The intended use in the Uso Previsto field and in the technical data sheet is worded identically (Chapter 6 item 2 e.i)
• □ On the device-predominant pathway, the document list and timeline for the drug quality and safety verification have been confirmed with the Quality Control Laboratory Directorate of ANRS
• □ It has been confirmed that the product contains no biological substances or human-derived components outside the reach of Article 11 of Chapter 5, or a separate written enquiry has been submitted to the DDM

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Nicaraguan market. Our team manages Ministry of Health (MINSA) sanitary registration applications through the regulatory directorate, prepares Spanish-language dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com