Classification Certificate Constancia de Clasificacion Under Article 28

1. Key takeaways

Acuerdo No. 0631-ARSA-2023, the Regulation for the Sanitary Control of Medical Devices and Other Devices of Sanitary Interest, provides in Article 28 a dedicated pathway for products that are not on the lists published by ARSA: an application may be made for a device classification certificate (constancia de clasificación), which can be processed in person at the ARSA offices or online through its official website. The provision sets 2 purposes for the certificate: 1 to identify whether the product falls within the sanitary-interest category, and 2 to determine the type of sanitary authorisation that corresponds to the device. Article 30 empowers ARSA to compile and update the device lists, and Article 53 again invokes Article 28 within the registration exemption regime — when the exemption list changes, or when a product is not on the list, a classification certificate may be requested. The GRZAN regulatory team notes that this is the only official outlet for classification uncertainty; a company self-assessment claiming that a product is not a device has no procedural effect, and it is the classification certificate that constitutes a written conclusion suitable for the compliance file.

• Products not covered by the ARSA lists may be submitted for a classification certificate.
• The certificate can be processed in person at ARSA or online through its website.
• Purpose one: identify whether the product is of sanitary interest.
• Purpose two: determine the corresponding type of sanitary authorisation.
• Article 53 links the certificate to the registration exemption regime.

2. Legal basis

The provisions below frame the classification certificate, the lists it interacts with, and the neighbouring categories that shape its use.

3. Expert insights

Insight one: the classification certificate resolves which route to take, not whether the product can be marketed. The two purposes given in Article 28 are to identify whether the product is of sanitary interest and to determine the corresponding type of sanitary authorisation. These map directly onto the 13 control instruments of Article 5 — the role of the certificate is to point the product to one of the routes: registration, registration exemption, RUIF / NTDM, or outside sanitary interest altogether. The certificate is itself not an authorisation.

Insight two: the parallel availability of online and in-person filing is a rare convenience in this market. Article 28 expressly allows processing in person or online through the ARSA website. For foreign companies this reduces the degree of dependence on a local agent — the determination stage does not require the registering company to appear, although the later classification report (Article 32) and registration (Article 43) still require the sanitary licence number of the registering company.

Insight three: Article 53 connects the classification certificate to the exemption regime. The provision states that when the exemption list changes, or when a device is not on the list, a classification certificate may be requested. This forms a closed loop: the list is the routine basis, and the certificate is the exception outlet. When an ARSA update moves a product out of the exemption scope, the company can use a classification certificate obtained beforehand to discuss transitional arrangements with the regulator.

Insight four: the lists are updated on a rolling basis, so a classification conclusion has a shelf life. Article 30 empowers ARSA to compile and update the lists, and Article 90 further provides that the regulation itself will be revised and supplemented as international regulatory practice develops. The GRZAN regulatory team therefore recommends that for borderline products the classification certificate be reviewed every 12 months and compared against the current version of the lists, so that imports are not continued on the strength of an outdated conclusion.

Insight five: the classification certificate does not remove the classification precondition of Article 31. The two pathways must be clearly distinguished: the classification certificate (Article 28) resolves whether the product is of sanitary interest and which type of authorisation applies, while the risk classification report (Articles 31 and 32) resolves which of Clase I to III the device falls into. A product that falls within a risk class still needs the classification report first; the certificate cannot substitute for it.

4. Practical recommendations

• For borderline products, request the classification certificate first and decide between registration, exemption or RUIF / NTDM only after the written conclusion is in hand.
• At the determination stage the foreign entity may apply directly online, without waiting for the registering company to be fixed.
• Archive the classification certificate and use it as the basis for communication when the exemption list changes.
• Review the classification conclusion for borderline products every 12 months against the current list version.
• Keep the distinction clear between the classification certificate, which sets the route, and the classification report, which sets the class; neither substitutes for the other.
• Update the internal product classification table as soon as the certificate is issued, as the starting point for later submissions.

5. Verification checklist

• □ A written ARSA classification certificate has been obtained for borderline products
• □ The filing route (registration / exemption / RUIF / NTDM) has been set according to the certificate
• □ The certificate is archived and can be compared against exemption list changes
• □ A 12-month review cycle is set for the classification conclusion of borderline products
• □ The different roles of the classification certificate and the classification report are documented internally
• □ The internal product classification table has been updated to match the certificate

Further reading: [Article 09 — The four risk classes](/honduras-medical-device-registration/four-risk-classes-i-iia-iib-iii/) | [Article 10 — Other devices of sanitary interest](/honduras-medical-device-registration/other-devices-of-sanitary-interest/) | [Article 06 — The 13 control instruments](/honduras-medical-device-registration/thirteen-control-mechanisms-article-5/)

Regulatory information verified as of 29 October 2026.

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