Central America Comparison: Nicaragua’s Classification Axis and Neighbours

1. Key takeaways

Nicaragua’s device classification axis does not derive from its neighbours. ANRS determines the risk level, I to IV, using the twenty-six rules in Annex B of NTON 24001:2023, and article 3 of Chapter 5 states expressly that the classification is not constrained by a classification already registered in another country. Among the three markets covered in this series, Costa Rica classifies under article 8 and Annex A of RTCR 505:2022 into Clase 1 to 4 and states in article 23 that it aligns with Canada’s SOR/98-282; Guatemala classifies under Annex 1 of NT-37 on a use-by-sterility basis into four classes; and Panama’s compliance document is the Certificado de Criterio Técnico, or CCT. Honduras and El Salvador will be completed once those volumes are delivered, and no view is offered here in the meantime.

• Nicaragua applies twenty-six rules in Annex B and does not defer to foreign classifications.
• The three comparison markets use different classification logics, so one product can land in different classes.
• The compliance document differs: a five-year sanitary registration certificate in Nicaragua, a CCT in Panama.
• IVD grouping follows different structures in Nicaragua and Guatemala.
• All four markets are in a period of regulatory change, but the instruments under revision differ.
• Honduras and El Salvador are left open rather than filled with unverified assumptions.

2. Legal basis

The table compares the classification basis, the compliance document and the current revision activity across the markets covered in this series.

3. Expert insights

The first point is that the differences are structural. Nicaragua is rule-driven: the twenty-six rules in Annex B decide the class from factors such as the route of invasion, the duration of contact and the site of contact. Guatemala is attribute-driven: two dimensions, use and sterility, are crossed. Costa Rica is rule-driven but benchmarked against Canada. The same product can therefore reach different conclusions in the three markets without any of the three being wrong on its own terms.

The second point is the strength of Nicaragua’s position. It is the only one of the six markets that writes the exclusion into the body of the main regulation: article 3 of Chapter 5 says “independientemente de la clasificación registrada en otro país”. Among the provisions verified so far, that is the hardest exclusionary wording; other markets either say that a foreign classification may be taken as a reference or say nothing at all.

The third point is the form of the compliance document. Nicaragua issues a Certificado de Registro Sanitario, valid for five years, with renewal keeping the same number; Panama issues a CCT for general devices. Asking about a sanitary registration certificate in Panama is a category error, and project plans need to be built around the document that the market actually issues.

The fourth point is IVD. Nicaragua brings IVD into the same four-level system, under rules 20 to 25 of Annex B, and sets out grouping detail for reagent kits, rapid tests, culture media and quality control materials in C.2 of Annex C. Guatemala runs IVD through a separate NT-40 channel with three tiers of sanitary risk. Grouping strategy therefore differs completely between the two, even for an identical assay menu.

The fifth point is the direction of recent change. Nicaragua has moved on two tracks at once, digitalisation and amendment: three administrative resolutions have moved licensing, registration, imports and authorisations online, while Adenda 2026-05 is rewriting the body of the rules. Costa Rica’s 2024 amendment addressed the origin of the CLV and a break in mutual recognition. Guatemala notified G/TBT/N/GTM/106 on 11 February 2026 with the intention of repealing the 712-99 government agreement after twenty-seven years in force. All three markets are in transition, but the instrument being changed is different in each.

The sixth point is the deliberate gap. The Honduras and El Salvador columns are left blank because legal source verification for those volumes is not complete. Anything written there would be an unverifiable assumption, and an empty cell is preferable to a comparison table filled with inference.

4. Practical recommendations

• Classify market by market rather than transposing a class: run the instructions for use and intended purpose against each market’s rules, using Annex B for Nicaragua, and keep a record of each determination.
• Build the project plan around the compliance document: sanitary registration with five-year validity and a twelve-item renewal in Nicaragua, the CCT and public procurement in Panama, sanitary registration with LNS testing in Guatemala. One Gantt chart will not serve several markets.
• Treat foreign classifications as background only, never as the basis for the Nicaraguan class, in line with Chapter 5, article 3.
• Design IVD grouping per market: the C.2 grouping detail in Annex C for Nicaragua, the reagent family rules of NT-40 for Guatemala.
• Include each market’s recent changes in an annual regulatory watch, tracking the finalisation of Adenda 2026-05 and subsequent Karplus and VUCEN adjustments for Nicaragua.
• Maintain a cross-market glossary, since the same concept carries different names (registro sanitario, CCT, Clase, Nivel de Riesgo), and map them consistently in internal documents.

5. Verification checklist

• □ The product has been reclassified under each target market’s own rules, with no transposition between markets.
• □ The compliance document and validity rule for each target market have been confirmed.
• □ Foreign classifications are used as background only and not as the basis for the Nicaraguan class.
• □ IVD filing units have been designed against each target market’s grouping rules.
• □ Recent regulatory changes in each market are on the annual watch list.
• □ A cross-market glossary has been created and is maintained.

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, prepares Spanish-language dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com