Classification Report Requirements Under Article 32

1. Key takeaways

Acuerdo No. 0631-ARSA-2023, the Regulation for the Sanitary Control of Medical Devices and Other Devices of Sanitary Interest, lists in Article 32 the 13 documents required for the risk classification report: 1 the application form (which must carry 17 groups of information: the receiving office, the legal representative, the legal agent, 5 items on the registering company, 7 items on the domestic distributing company, the brand name, the generic name, 4 items on the product owner, 4 items on the manufacturer, 4 items on the international intermediary distributor, the product description and intended use, commercial specifications, reference code / model / series, international codes, the CAS number, place and date, and signature and thumbprint); 2 the declaration specific to classification reports; 3 a copy of the company by-laws or the registration of the individual merchant; 4 primary, secondary and/or tertiary packaging labels; 5 5 supplementary items for biomedical devices; 6 6 supplementary items for IVDs; 7 supplementary labels; 8 a copy of the professional card of the legal agent; 9 the power of attorney with its authentication; 10 the credentials of the technical manager of the premises; 11 the DNPF permit where controlled substances are involved; 12 translation and authentication of all foreign documents; 13 the proof of payment. An extension application needs only 5 documents. The GRZAN regulatory team notes that Article 32 pushes most of the qualitative information forward into the classification stage — the registration stage (Article 43) adds evidence on top of this basis rather than starting over.

• The application form carries 17 groups of information covering four legal parties.
• 13 documents are required for a new classification report; an extension needs only 5.
• Biomedical devices add 5 supplementary items and IVDs add 6.
• All foreign documents must be translated and authenticated.
• Most qualitative information is collected at the classification stage, not at registration.

2. Legal basis

The rows below reproduce the documentary requirements of Article 32 that carry the greatest practical weight in dossier preparation.

3. Expert insights

Insight one: the 17 groups of information in the application form capture the four-party legal relationship in one pass. Items d) through k) of Article 32.1 require the names, addresses, emails and websites of the registering company, the domestic distributing company, the product owner and the manufacturer, together with the international intermediary distributor where the purchase is not made directly from the product owner. The practical value of this block is that it fixes the supply chain structure into the official file; within the 12 types of change under Article 52, the changes of manufacturer and country of origin, of product owner, and of or addition to distributors are all checked against these entries.

Insight two: the international codes and the CAS number must be submitted at the classification stage. Item n) of Article 32.1 requires the international codes to be stated according to GMDN, UMDNS or EMDN, and item o) requires the CAS number where chemical substances are involved. Both items reappear in the registration dossier of Article 43 (items o) and p) of its item 1), which shows that classification and registration must use the same code set and the same CAS numbers; a mid-course change would be treated as an inconsistency.

Insight three: the supplementary lists for IVDs and biomedical devices take effect at the classification stage. Item 5 of Article 32 (5 items for biomedical devices) and item 6 (6 items for IVDs) overlap heavily with, but are not identical to, the corresponding lists in the registration dossier of Article 43 — the classification-stage IVD list requires storage conditions and storage-and-transport conditions side by side, while the registration stage additionally requires technical documents supporting the shelf life or stability. The sensible practice is to prepare to the registration standard and reuse the documents at the classification stage, avoiding two rounds of deficiency letters.

Insight four: the translation and authentication requirement of item 12 covers all foreign documents. The provision states that foreign documents must be duly translated and authenticated. Read together with the apostillado o autenticado wording that recurs across the change items of Article 52, the uniform handling rule for foreign documents in this market is: translate into Spanish first, then obtain the apostille or consular authentication. This must be in place at the classification stage and cannot be left to the registration stage.

Insight five: the 5-document extension is a low-cost time management tool. The extension paragraph of Article 32 compresses the requirements to the application form, the declaration specific to extensions, the evidence of exclusive distribution, the packaging labels and the proof of payment. Against the 13 documents of a new application, the marginal cost of an extension is very low — the GRZAN regulatory team therefore recommends that whenever completing registration within 6 months looks uncertain, the extension be requested in month 4 or 5, stretching the window to 12 months.

4. Practical recommendations

• Collect the information for the registering company, the domestic distributor, the product owner, the manufacturer and the international intermediary distributor in one pass and build a standard data table.
• Use a single international code set (GMDN, UMDNS or EMDN) throughout the file and keep classification and registration consistent.
• Prepare the supplementary documents for IVDs and biomedical devices to the registration standard and reuse them at the classification stage.
• Handle all foreign documents uniformly as translation into Spanish followed by apostille or consular authentication, starting at the classification stage.
• Where completing registration within 6 months is uncertain, request the extension in month 4 or 5 with only 5 documents.
• Start the DNPF permit application in parallel for products containing controlled substances; do not fold it into the classification timeline.

5. Verification checklist

• □ The four parties (registering company, distributor, product owner, manufacturer) are captured in a standard data table
• □ One of the three international code sets has been chosen and is used consistently in classification and registration
• □ Supplementary documents for IVDs and biomedical devices are prepared to the registration standard
• □ Foreign documents have been processed as translation plus apostille or consular authentication
• □ The extension decision point (month 4 or 5) is written into the project plan
• □ The DNPF permit application has been started in parallel for controlled-substance products

Further reading: [Article 13 — Risk classification report, six months](/honduras-medical-device-registration/risk-classification-report-six-months/) | [Article 30 — Foreign documents and powers of attorney](/honduras-medical-device-registration/foreign-documents-translation-and-apostille/) | [Article 28 — Additional documents for IVDs](/honduras-medical-device-registration/ivd-specific-requirements/)

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