Acronyms and Definitions Under Article 3

1. Key takeaways

Article 3 of Acuerdo No. 0631-ARSA-2023, the Reglamento para el Control Sanitario de Dispositivos Médicos y otros Dispositivos de Interés Sanitario, has two sections: section I lists 31 acronyms and abbreviations, and section II lists in alphabetical order more than 80 definitions, from Accesorio para un Dispositivo Médico to Vigilancia Sanitaria. The abbreviations most critical for applicants are CDM (Certificado de Dispositivo Médico, the risk classification report), CLV (Certificado de Libre Venta, the free sale certificate), RUIF (authorisation for devices used only for research and forensic purposes) and NTDM (authorisation for products used to control the quality of food, drinking water and laboratory water). The definitions section separately defines Titular del producto (the product holder: the legal person responsible for the design, manufacture, repackaging and labelling of the device, owning all legal and intellectual property rights) and Fabricante (the manufacturer: whoever designs or manufactures the device and places it on the market in its own name). The GRZAN regulatory team notes that in Honduran dossiers the Titular and the Fabricante are two separable entities; complete forms according to the definitions, not according to group internal habit.

• CDM carries two names in the regulation: the operative provisions use Informe de Clasificación por Riesgo Sanitario.
• When a registering company claims to be the Titular, Article 43 item 9 requires a manufacturing or tolling contract.
• An Autoridad Reguladora estricta is a regulator assessed at the highest maturity level under the WHO/PAHO global benchmarking tool.
• Device coding accepts GMDN, UMDNS or EMDN, but one scheme must be used consistently across the dossier.

2. Legal basis

The provisions on abbreviations and definitions are the following.

3. Expert insights

Insight 1: the abbreviation CDM is the key to reading the procedures of this market. Section I of Article 3 defines CDM as Certificado de Dispositivo Médico, while Articles 31 and 32 use the formal name Informe de Clasificación por Riesgo Sanitario. One document, two names: if only one of the names is used in window communication or form filling, it can be mistaken for something else. Fix the wording in internal documents as the risk classification report (CDM / Informe de Clasificación por Riesgo).

Insight 2: Titular and Fabricante are separable, but responsibility is not. Article 3 defines the Titular as the legal person owning all legal and intellectual property rights and responsible for design, manufacture, repackaging and labelling, and the Fabricante as whoever designs or manufactures and places the product on the market in its own name. Article 43 item 9 requires that when the registering company claims to be the Titular, it must submit a manufacturing or tolling contract. This turns the question of who may claim to be the product holder into one that needs documentary support, so tolling businesses must prepare early.

Insight 3: the Autoridad Reguladora estricta is the gateway to reliance routes in this market. Article 3 defines it as a regulatory authority assessed at the highest maturity level under the WHO/PAHO global benchmarking tool. Article 42 items 1 and 2, together with Articles 72 and 73, accept emergency use authorisations from strict regulatory authorities on that basis, while Article 47 allows recognition of registrations from ARN authorities at GBT maturity level 3 or 4. Note that the thresholds differ: emergency use authorisation requires a strict regulatory authority, while registration recognition requires only maturity level 3 or 4, a clearly lower bar.

Insight 4: CE and CEE survive as abbreviations but appear only in the list of equivalent documents. Section I of Article 3 lists CE (Conformidad Europea) and CEE (Comunidad Económica Europea). Article 46 item 5 lists CE certificates (devices 93/42/CEE, in vitro diagnostics 98/79/EC) among the documents of the same origin acceptable when the required documents cannot be submitted. CE in Honduras is therefore not a prerequisite but a substitute route: it is used only when the required documents cannot be obtained, and must not be filed as a routine document.

Insight 5: the three coding schemes GMDN, UMDNS and EMDN stand side by side as options. Article 32 item 1 letter n) and Article 43 item 1 letter o) both require international coding under GMDN, UMDNS or EMDN. Any one of the three suffices, but the same scheme must be used throughout a dossier, and the classification report and the registration application must use the same scheme, otherwise the filing is treated as inconsistent.

4. Practical recommendations

• Fix the wording risk classification report (CDM / Informe de Clasificación por Riesgo) in internal documents to avoid ambiguity in window communication.
• Tolling manufacturers should have the manufacturing or tolling contract ready before filing, as the supporting document for claiming Titular status.
• Evaluate the Article 47 route: where a registration is already held in a country at GBT maturity level 3 or 4, prepare the recognition application documents.
• Position CE certificates as equivalent documents, submitted only where the required documents cannot be provided, never as routine material.
• Use one international coding scheme (GMDN, UMDNS or EMDN) throughout the dossier, keeping the classification report and the registration application consistent.
• Convert the 31 abbreviations of Article 3 section I into an internal reference table for translators and form preparers.

5. Verification checklist

• □ An internal reference table of the 31 abbreviations of Article 3 section I exists
• □ One of the three device coding schemes has been chosen and applied consistently across the classification report and registration application
• □ The manufacturing or tolling contract is ready for tolling-type companies
• □ The Article 47 recognition route for GBT maturity level 3 or 4 registrations has been assessed
• □ CE certificates are submitted only in equivalent-document situations, not as routine material
• □ The entries for Titular and Fabricante in the dossier match the Article 3 definitions

Regulatory information verified as of 2026-10-29.

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