Four Risk Classes: I, IIA, IIB and III

1. Key takeaways

Honduras classifies medical devices into 4 risk classes (Article 29 of Acuerdo No. 0631-ARSA-2023, the Reglamento para el Control Sanitario de Dispositivos Médicos y otros Dispositivos de Interés Sanitario): Clase I, low risk, subject to general controls, not used to protect or sustain life and not of special importance in the prevention of damage to health, and posing no potential risk of illness or injury; Clase IIA, moderate risk, requiring special controls at the production stage to demonstrate effectiveness; Clase IIB, high risk, requiring special controls at the design and production stages to demonstrate safety and effectiveness; Clase III, very high risk, requiring special controls, used to protect or sustain life or of substantial importance in the prevention of damage to health, or whose use poses a potential risk of illness or injury. Classification takes the intended use (finalidad prevista) declared by the product holder as the pivot, together with the anatomical site of application, the duration of contact with the body, the degree of invasiveness, and whether the device releases medicines or energy. Article 30 empowers ARSA to compile and update device lists.

• Intended use is the only subjective input; the other four criteria are objective determinants, so the same hardware can fall into different classes depending on the declared intended use.
• Dossier requirements accumulate in sequence: a Clase III file equals the full Clase I set plus the IIA, IIB and III additions.
• The classification report is valid for 6 months and can be extended once, for a further 6 months, under Article 31.

2. Legal basis

The provisions on classification and its documentary consequences are the following.

3. Expert insights

Insight 1: classification accumulates in sequence rather than running in parallel tracks. Article 44 requires Clase IIA applicants to submit the documents of Article 43 plus ISO 13485; Article 45 requires Clase IIB applicants to submit those of Articles 43 and 44 plus the specific standards; Article 46 requires Clase III applicants to submit those of Articles 43, 44 and 45 plus the four tests and equivalent documents. In other words, a Clase III dossier equals the full Clase I set plus the IIA additions, the IIB additions and the III additions. Budgets and timelines must be estimated by cumulating up to the highest class, not by the increment between adjacent classes.

Insight 2: the definitions of Clase I and Clase III are mirror images. The Clase I definition contains three negative elements: not used to protect or sustain life, not of special importance in the prevention of damage to health, and posing no potential risk of illness or injury. The Clase III definition restates nearly the same elements affirmatively. This drafting means that borderline products turn on the wording of the intended use: the same monitor declared for life support and declared for general monitoring will land at opposite ends.

Insight 3: the list of Article 30 is the operational carrier of classification. The provision empowers ARSA to compile and update device lists, while Article 28 offers a classification certificate route for products not on the list. The practical advice for applicants is to search the list first and apply for a classification certificate only if the product is not found; do not skip the list and file a self-assessed class, because Article 31 expressly requires the classification report from ARSA first, and a self-assessment has no procedural effect.

Insight 4: the classification outcome feeds back into establishment duties. Article 9 lists Clase I devices as one of the three exemptions from the technical manager requirement, while Clase IIA and above add ISO and testing documents. A single classification outcome therefore determines staffing, document volume and cost at once. The classification report (CDM) should thus be the first milestone of the project schedule, not an annex to the registration documents.

Insight 5: the classification report has a clock, and higher classes run out of time more easily. Article 31 gives the classification report 6 months of validity with a single 6-month extension, while Clase III requires four tests and a certificate of analysis of the finished product, whose preparation often exceeds 6 months. The GRZAN regulatory team advises that Clase III projects complete testing before the classification report is issued; otherwise the project depends on the extension or even a new classification application.

4. Practical recommendations

• Estimate budget and timeline on a cumulative-to-highest-class basis: Clase III equals the full Clase I set plus the IIA, IIB and III additions.
• Have regulatory and marketing departments co-sign the intended use wording of borderline products, avoiding two classifications for one piece of hardware.
• Search the ARSA list first and apply for a classification certificate under Article 28 only where the product is not found; never skip the list in favour of self-assessment.
• Set the classification report (CDM) as the first project milestone, starting before document preparation.
• For Clase III projects, schedule biocompatibility, stability, cytotoxicity and electrical safety testing before the classification report is issued.
• After the classification conclusion is issued, recheck technical manager staffing and the document list to catch the additions.

5. Verification checklist

• □ The risk class of the product has been confirmed in a formal ARSA classification report
• □ Budget and timeline have been estimated on the cumulative-to-highest-class basis
• □ The intended use wording of borderline products has been co-signed by regulatory and marketing
• □ The ARSA list was searched first, and products not found have a pending or obtained Article 28 certificate
• □ The four tests of Clase III projects are scheduled before issue of the classification report
• □ Staffing and the document list were rechecked once the classification conclusion was issued

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