ANRS Sets the Risk Class Itself

1. Key takeaways

In Nicaragua the risk class is determined by ANRS itself under Annex B of NTON 24001:2023, and it is not bound by the classification registered in another country. The wording of Chapter 5 Article 3 is independientemente de la clasificación registrada en otro país. A US FDA class or an EU CE classification already obtained by the company can only be submitted as the market-access evidence required by Chapter 6 (CLV, FDA certificate, CE certificate); it cannot serve as the basis for classification in Nicaragua. Where there is doubt about whether a product is a device or needs registration, the route is Annex D under Chapter 5 Article 4, with the DDM issuing the official classification certificate.

2. Legal basis

The table below sets out the provisions governing who classifies, on what basis, and how the market-access evidence relates to the process.

3. Expert insights

Point 1: The word independientemente is the strong wording of this provision. The standard does not say that foreign classifications may be taken into account; it excludes them outright. This runs in the opposite direction from markets that treat a reference-country classification as a fast track or a simplified route, and it means that registration experience in other markets cannot be transposed into a classification conclusion for Nicaragua.

Point 2: Within the standard, the power to classify and the evidence chain are separated. Chapter 5 Article 3 governs how the class is determined, and Chapter 6 items 7 and 9 govern how the applicant proves that the product is already lawfully on the market elsewhere. Foreign certificates belong to the latter. Submitting FDA or CE documents in the dossier does not mean that ANRS will classify on that basis; the two actions are adjacent in the submission process but legally unrelated.

Point 3: Item 7 of Chapter 6 is flexible about who issues the CLV. It may be the competent authority of the country of manufacture or a regional reference body of OPS or OMS. For the company, the classification basis and the market-access evidence may come from different countries, and where the CLV carries no validity period it is counted as 2 years from the date of issue. This flexibility means that the absence of a CLV from the country of manufacture no longer necessarily blocks submission, but it does nothing to weaken the independence of classification under Chapter 5 Article 3.

Point 4: The provision closes its loop with Chapter 5 Article 4. Self-classification by the company under Annex B is the normal case; where an official ruling is needed, the route is Annex D. Article 4 of Annex D states that the classification certificate is issued under Annex B, which connects the three elements: the power to classify (ANRS), the decision rules (Annex B) and the ruling procedure (Annex D).

Point 5: Family grouping does not change the classification logic. Chapter 7 Article 7 allows a product family to share a single registration number, with the grouping criteria in Annex C, but each product in the group must still land on its own rule of Annex B. Sharing a registration number does not mean sharing a class.

Point 6: The practical consequence is direct. The document list and the timeline in Nicaragua cannot be back-calculated from a foreign class. Converting a US Class II into a Nicaraguan Class II is a common source of error, and once the conversion conflicts with a rule of Annex B, the rework happens only after the dossier has been fully assembled.

4. Practical recommendations

• Classify independently under Annex B at the project stage and refrain from any conversion against FDA or CE classifications throughout; foreign classifications may be kept in internal files as background, but must not be written into the classification conclusion.
• Manage the CLV, the FDA certificate and the CE certificate in the dossier under a market-access evidence section, kept separate from the classification conclusion, so that the reviewer does not misread them as the classification basis.
• Ensure the classification conclusion and the intended-use wording support each other: most rules of Annex B take invasiveness, contact site and duration of use as their elements, and an intended use that drifts changes the applicable rule directly.
• Do not self-infer borderline products; follow Chapter 5 Article 4 through Annex D and start dossier preparation only after the DDM has issued the classification certificate.
• Record the classification basis model by model in a family grouping, producing a model-rule-class cross-reference table for reuse in later expansions and changes.
• Maintain a tracking record for Adenda 2026-05 against Chapter 5 Article 3: the first visible change found in the consultation draft sits in the Chapter 4 definitions, and whether Chapter 5 is adjusted is a matter for the officially published final text.

5. Verification checklist

• □ The classification conclusion was formed independently under the rules of Annex B, without citing any foreign classification as basis
• □ The CLV, FDA certificate and CE certificate in the dossier are filed as market-access evidence and meet the issuing-body and legalisation requirements of Chapter 6 items 7 and 9
• □ The FDA certificate is submitted only where the product is manufactured in the United States (Chapter 6 item 7)
• □ Whether an Annex D classification certificate must be requested from the DDM under Chapter 5 Article 4 has been determined
• □ For family grouping products, the classification basis is recorded model by model (Chapter 7 Article 7, Annex C)
• □ A tracking record for Adenda 2026-05 against Chapter 5 Article 3 has been established

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