Donation authorisation under Article 76: company registration, 11 documents and 9-month shelf life

1. Key takeaways

Donated devices travel through their own separate channel. Article 76 of Acuerdo No. 0631-ARSA-2023 first sets a gate in front of everything else: where the applicant is a legal entity (a company or a non-governmental organisation), it must first complete the registro de empresa (company registration), submitting the articles of incorporation, the name and identity documents of the legal representative, and, where a legal agent is appointed, the authorisation and professional card. The provision states in a note that natural persons and government bodies do not need the company registration. The formal application contains 11 items, including the application form (covering the receiving institution, beneficiaries, mode of transport, port of entry and estimated arrival date), a pro-forma invoice or a letterheaded donation certificate (signed and sealed by the donor or the legal representative, issued in the country of origin, in the ARSA format), an epidemiological, social or personal justification, a product detail sheet (the shelf life of each product must not be below 9 months, except where ARSA determines otherwise), and the acceptance letter and commitment letter of the receiving institution (committing to non-commercial use; and to destruction or re-export if the products are subject to a health alert). If an excess quantity appears at clearance, a modification of the authorisation must be applied for; products not fully distributed may be donated internally under ARSA supervision, otherwise destroyed, with the costs and procedures borne by the receiving institution.

2. Legal basis

Article 76 regulates the donation channel end to end, from the company registration gate to disposal of undistributed goods, and Article 74 provides the parallel shelf-life rule. The table below consolidates the provisions.

3. Expert insights

Insight 1: the first gate of the donation channel is the company registration, not the product documents. Article 76 places the registro de empresa before the application and exempts only natural persons and government bodies. Non-governmental organisations, foundations and corporate social responsibility entities must complete this step first; however complete the later documents are, the application cannot be accepted without it. This is the most common cause of delay in donation projects.

Insight 2: the 9-month shelf life applies product by product here. Item 6(a) requires the detail sheet to state the shelf life for each product and not below 9 months. This matches the Article 74 requirement for AEP but at finer granularity: not an approximate shelf life per batch, but a per-item statement, together with declared batch numbers and quantity per batch.

Insight 3: the commitment letter fixes the responsibility of the receiving institution. The commitment letter of item 8 must be signed and sealed by the legal representative or technical director of the receiving institution and declare that the products will be used for non-commercial purposes only; if the products are subject to a health alert (alerta sanitaria), they are to be destroyed or re-exported. Items 10 and the final paragraph go further: products not fully distributed are donated internally or destroyed, and the related procedures and costs are borne by the receiving institution. A donation does not end at handover; the recipient must manage the goods all the way to final disposal.

Insight 4: excess quantity is a change matter, not a tolerance. Item 9 provides that where the quantity of products at clearance exceeds the authorisation, a modification must be applied for through the link ARSA sends by email when issuing the authorisation. This converts an extra carton from a goodwill error into a change that must follow procedure; checking loaded quantities against the authorised quantities before container loading is critical.

Insight 5: inspections throughout, and destruction requires an environmental licence. The final paragraph requires the application to state the dates and exact places of distribution and to accept inspections during and afterwards; non-compliant products are re-exported or destroyed at premises or by enterprises holding a valid environmental licence. The environmental licence is an independent external qualification, and cross-border donation projects often need to confirm in advance whether a qualified destruction provider exists locally.

4. Practical recommendations

• Start projects with the company registration: NGOs and companies complete the registro de empresa before filing the donation application; natural persons and government bodies are exempt but should have identity documents ready.
• Check shelf life item by item before loading: nothing below 9 months goes into the container, and the detail sheet lists batch number, quantity and shelf life per item.
• Issue the donation certificate in the ARSA format in the country of origin: letterheaded paper, signed and sealed by the donor or legal representative; a pro-forma invoice may substitute, provided all fields are complete.
• Collect the acceptance letter and commitment letter of the receiving institution together, with the commitment letter stating non-commercial use and the disposal method in case of a health alert.
• Write the distribution plan into the application: dates and places listed item by item to ease later inspection reconciliation, with the distribution ledger kept consistent with the application.
• Confirm in advance whether the local destruction provider holds a valid environmental licence, and include it in the project budget (costs and procedures are borne by the receiving party).

5. Verification checklist

• □ Nature of the applicant confirmed and, for legal entities, the company registration completed
• □ The 10 classes of application data are complete (including receiving institution, beneficiaries, port and arrival date)
• □ Pro-forma invoice or donation certificate issued in the ARSA format in the country of origin
• □ Product detail sheet lists batch number, quantity and shelf life per item, all not below 9 months
• □ Acceptance letter and non-commercial use commitment letter of the receiving institution are signed and sealed
• □ Distribution date and place list has been compiled and matches actual execution
• □ Contingency for destruction or re-export and a qualified provider are in place

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

Regulatory information verified as of October 29, 2026.