Four Risk Levels I to IV

1. Key takeaways

Nicaragua classifies medical devices into four risk classes, from lowest to highest I, II, III and IV. The semantic basis is definition item 33 of Chapter 4 of NTON 24001:2023, and the decision basis is the 26 classification rules of Annex B of the same standard, which is a normative annex (normativo). The risk class is determined by ANRS itself under Annex B (Chapter 5 Article 3), and it also determines whether the product falls within controlled-technology devices under definition item 10. Two textual issues must be noted: item 33 uses the word Clase while Annex B uses Nivel de Riesgo throughout; and Rule 8 d) of Annex B refers to a Nivel de Riesgo VI, a class that does not exist in the standard.

2. Legal basis

The table below lists the classification provisions of the standard and the pending amendment that touches Chapter 4.

3. Expert insights

Point 1: The terminology is dual-track within the standard itself. Item 33 reads Se clasifican en Clase I, II, III y IV, while the rules of Annex B consistently read Nivel de Riesgo I to IV. The two formulations coexist in the same standard and mean the same thing. This volume uses risk class I, II, III and IV as the uniform expression and keeps the original wording when quoting specific provisions, so that the text can be set against the official version line by line.

Point 2: Item 33 gives risk semantics, not decision rules. It describes roughly what degree of risk each class corresponds to: I very low, II low to moderate, III moderate to high, and IV the most critical in terms of risk. It provides no decision elements at all. A company cannot claim Class I by asserting that its product looks low-risk; classification must land on a specific rule number of Annex B.

Point 3: Rule 8 d) of Annex B contains the phrase se clasifican en Nivel de Riesgo VI, a class that does not exist in the standard. Subparagraphs a) to c) and e) to j) of the same rule all take values between II and IV, and item 33 also lists only four classes. This volume reads that subparagraph as Class IV, and recommends written confirmation of the class with the DDM for implantable or long-term invasive surgical devices involving chemical change in the body. This is one of the numbering errors found in the official text during the preparation of this volume.

Point 4: Rule 5 of Annex B contains two subparagraphs lettered b, and the provisions that follow never receive the letter c. This is the second numbering problem in the same annex. Companies citing Rule 5 for classification must cite the specific subparagraph, to avoid ambiguity in later renewals or changes.

Point 5: Annex B Rule 11 is the only classification landing point for software in Nicaragua, and it is three-tier. Software used for therapeutic or diagnostic decisions is Class II; where the decision could cause death or irreversible harm to health it is Class IV, and where it could cause serious harm to health or require surgical intervention it is Class III. Software used to observe physiological processes is Class II, and Class III where the vital parameters observed could, if they varied, immediately endanger the patient. All remaining software is Class I. This rule must be read together with the SaMD definition that Adenda 2026-05 proposes to add.

Point 6: The class does more than determine the document list. Item 10 lists devices placed in Classes III and IV under the standard as one of the constituent elements of controlled-technology devices. The class therefore triggers special controls as well, and it is the starting point of the chain of obligations, not its end.

4. Practical recommendations

• Classify along the path from rule to class: compare the product against the 26 rules of Annex B one by one, form a written conclusion and note the rule numbers relied on, rather than fixing the class first and looking for a rule afterwards.
• For implantable or long-term invasive surgical devices falling under Rule 8 d) of Annex B, meaning chemical change in the body, prepare the dossier at Class IV and confirm the class with the DDM in writing.
• Classify software products through the three tiers of Rule 11: first separate decision-type from observation-type software, then assess the tier of the harm consequence.
• Do not use the classification registered in another country as the basis for classification in Nicaragua (Chapter 5 Article 3); FDA or CE classifications may be kept in internal files as background only.
• For borderline products, where it is uncertain whether the item is a device or needs registration, apply for an official classification ruling under Annex D, with the DDM issuing the conclusion under Annex B.
• Archive the classification conclusion together with the rule numbers relied on, for reuse at renewal, post-registration changes and family grouping expansions, so that the same product does not end up with two classes at different stages.

5. Verification checklist

• □ The product has been compared rule by rule against Annex B, with a written classification conclusion noting the rule numbers relied on
• □ The classification conclusion does not cite any foreign classification as its basis (Chapter 5 Article 3)
• □ It has been checked whether the product meets the constituent elements of controlled-technology devices in item 10
• □ Software products have been classified through the three tiers of Rule 11 of Annex B
• □ Products under Rule 8 d) have been prepared at Class IV and confirmed with the DDM in writing
• □ The consistency between the classification conclusion and the Annex D classification certificate has been cross-checked

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