Central America Six Country Comparison

1. Key takeaways

The six Central American markets have no unified device registration system, and their classification axes differ from one another. Costa Rica classifies Clase 1 to Clase 4 risk under the rules of Article 8 and Annex A of RTCR 505:2022, and states in Article 23 that it is partially consistent with the Canadian SOR/98-282 Medical Devices Regulations; Guatemala classifies four classes under the use-times-sterility axis of Annex 1 of NT-37; and Panama’s compliance instrument is the Certificado de Criterio Técnico (CCT) rather than a sanitary registration in the traditional sense. The GRZAN regulatory team notes: no classification conclusion may be transferred directly from one market to another. Each of the three axes has its own entry point for determination, and transferring a conclusion leads directly to classification errors and mismatched documentation.

• Costa Rica is the only market of the six that states a benchmark to Canadian rules in the text of its regulation (Article 23, CONCORDANCIA).
• Guatemala’s axis is use times sterility (NT-37 Annex 1), which is not cognate with Costa Rica’s Annex A rule set.
• Panama’s difference lies not in classification but in the instrument: a CCT, valid 5 years and free of charge, rather than a sanitary registration.
• Quality system evidence sits at different thresholds: Panama requires a current ISO 13485 certificate, Costa Rica’s BPM certificate is deferred until the national BPM regulation is issued.
• IVD channel structures also differ: one four-class system in Costa Rica, an independent three-tier NT-40 track in Guatemala.

2. Legal basis

The comparison in this volume draws on the main regulation of each market, together with the companion volumes of this series already delivered for Panama and Guatemala, which supply the instrument-level detail for those two markets.

3. Expert insights

Insight one: Costa Rica is the only market among the six that states its benchmark to Canadian rules in the body of its regulation. Article 23, under the heading CONCORDANCIA, states directly that the regulation is partially consistent with the Canadian SOR/98-282 Canadian Medical Devices Regulations. This means teams familiar with the Canadian rules hold a clear first-mover advantage in Costa Rica — the rule structure of Annex A is isomorphic with the Canadian classification rules, and the neighbouring markets have no such correspondence.

Insight two: Guatemala’s classification axis is not cognate with Costa Rica’s. NT-37 Annex 1 classifies four classes by use times sterility: Class I is external use and non-sterile, Class II external use and sterile, Class III internal use and non-sterile, and Class IV internal use and sterile, with Class I the only class exempt from LNS testing. The same product may be classified Clase 1 in Costa Rica under Annex A rule 3 b) (reusable surgical instruments) while in Guatemala the answer depends on its sterile status — the two conclusions can be entirely different.

Insight three: Panama’s difference lies not in classification but in the form of the instrument. Panama currently issues the Certificado de Criterio Técnico for general devices (DE 490 Article 21: valid 5 years, no fee, required for public institution procurement), rather than a sanitary registration in the traditional sense; for certain categories such as condoms it issues the Certificado de Inscripción, with an official fee of B/.300.00 and a response period of 30 working days. When a company asks in Panama how many years the registration is valid, the question itself is misaligned.

Insight four: The thresholds for quality system evidence sit at different places. Panama writes a current valid ISO 13485 certificate into its general document list (DE 416 of 2020-05-13, rewriting DE 490 Article 36 item 10); Costa Rica requires a BPM certificate (Article 11.5), which under Transitorio I of the approving decree is not mandatory until the national BPM regulation is issued, with Transitorio IV requiring the Ministry of Health to publish it within 12 months of entry into force. One hard, one deferred — a distinction to build into scheduling and budgeting.

Insight five: The IVD channel structures are also different. Costa Rica places IVDs inside the same four-class system, with alternative routes only at Articles 12.3 and 12.4 (Clase 3) and Article 13.2 (Clase 4); Guatemalan IVDs follow the independent NT-40 track, classified by sanitary risk into Categoría I, II and III, and reagents, calibrators, controls, buffers or solutions may be grouped as one reagent family in a single sanitary registration. Grouping strategy is therefore designed completely differently in each market.

Insight six: The direction of recent changes also differs. Costa Rica’s 2024 amendment (MS-AJ-CB-200-2024) addressed CLV sourcing and the break in equivalence recognition; Panama’s notification of 2025-12-17, G/TBT/N/PAN/135, proposes rewriting the full device process through a new executive decree; Guatemala’s notification of 2026-02-11, G/TBT/N/GTM/106, with a proposed effective date of 2026-12-01, would repeal the 712-99 government agreement after 27 years. All three markets are in a generational transition, but its levers differ.

4. Practical recommendations

• Reclassify market by market, without transferring conclusions: rerun the product description and intended use through each target market’s rules — Annex A for Costa Rica, NT-37 Annex 1 for Guatemala, the current DNDM position for Panama — and keep a determination record for each.
• Plan the project around the form of the instrument: in Costa Rica schedule sanitary registration with 5-year validity and the 11 renewal items; in Panama schedule the CCT around public procurement; in Guatemala schedule the sanitary registration with LNS testing for Classes II to IV. Do not force one Gantt chart onto three countries.
• Prepare quality system evidence per market: a current ISO 13485 certificate for Panama; for Costa Rica, target-factory quality system documentation ready with an interface reserved during the BPM deferral. Do not wait for the authority to ask.
• Design IVD grouping per market: in Costa Rica plan under the seven consolidation scenarios of Article 10.7; in Guatemala plan under the reagent family rules of NT-40. The two grouping logics are not interchangeable.
• Bring recent changes into annual regulatory tracking: Costa Rica — the BPM regulation and the recognition list; Panama — approval and entry into force of G/TBT/N/PAN/135; Guatemala — the 2026-12-01 effective date and transition arrangements of G/TBT/N/GTM/106.
• Build a cross-market terminology table: the same concept carries different names (EMB, dispositivo médico, CCT, registro sanitario); map them consistently in internal documents to avoid misfiling during applications.

5. Verification checklist

• □ Classification has been redetermined under each target market’s own rules, with no cross-market transfer
• □ The compliance instrument form and validity rules of each target market have been confirmed
• □ Whether the product is registration-exempt or testing-exempt in each market has been confirmed
• □ Quality system evidence (ISO 13485 or a BPM plan) is ready per market requirements
• □ IVD filing units have been designed under each market’s own grouping rules
• □ Spanish labelling and, where applicable, supplementary labels have been completed per market
• □ Recent regulatory changes in each target market are in the annual tracking list
• □ A cross-market terminology table has been built and is maintained

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