Donations and samples: the additional import documents

1. Key takeaways

Article 6.4.2 a), item 7, of RTS 11.03.02:21 places donations among the situations eligible for special import. Article 6.4.2 e) then lists the additional documents for that situation, of which five relate directly to a donation: the donation certificate (Certificado de donación), the letter or note offering the donation (Carta o Nota de Ofrecimiento del donativo), the letter accepting the donation (Carta de aceptación del donativo), a copy of the Diario Oficial (Copia del Diario Oficial) and the donated medical device form (Formulario de dispositivos médicos donados).

The sample category follows a separate route within the same article. It requires a sworn declaration for the import of samples (Declaración jurada para importación de muestras) and, where relevant, the application form for authorisation of clinical use. The full list of additional documents in item e) runs to fourteen items, and the applicable subset is selected according to the type of permit being requested.

The practical reading is that a donation is not exempt from control; it is exempt from prior registration but subject to a five-document closed loop. Each of the five supports a different element of the transaction, and the shipment cannot be released if any one of them is missing.

2. Legal basis

The provisions governing donations and samples, the additional documents attached to each, and the restrictions on the subsequent use of donated goods are set out below.

The provisions cited in this article are Articles 2.1, 6.2.4.1 c), 6.4.2 a) and e) and 6.5.1 d) of RTS 11.03.02:21, Dispositivos Médicos. Requisitos para la Regulación Sanitaria de Dispositivos Médicos (Acuerdo No. 14-2022, Diario Oficial No. 156, Tomo No. 436, 2022-08-23).

Regulatory information verified as at 29 October 2026.

3. Expert insights

Insight one: a donation is not duty-free and inspection-free; it is registration-free but carries five additional documents. Article 6.4.2 a) places donations in the special import route, which confirms that no prior sanitary registration is needed. Item e) then requires a closed loop of five documents: the donation certificate, evidencing that the donation exists; the offer letter, evidencing the donor’s intention; the acceptance letter, evidencing the recipient’s agreement; the copy of the Diario Oficial, evidencing publication; and the donated device form, evidencing what is in the consignment. If any one of the five is missing, the donation cannot clear.

Insight two: the copy of the Diario Oficial is the item most easily overlooked, and it points to a publication step. The inclusion of a copy of the Diario Oficial in item e) indicates that the donation may need to be published in the official gazette. GRZAN treats publication as a separate preceding action when handling donation projects, because the gazette has its own schedule and that schedule sits outside the review clock of the SRS. Sequencing publication after the dossier is otherwise complete is the usual reason a donation consignment misses its planned arrival window.

Insight three: donations and samples share one import channel but require different additional documents. Donations fall under situation 7 and samples under situation 4, both within Article 6.4.2 a). The sample route, however, calls for the sworn declaration for the import of samples and, where clinical use is intended, the application for authorisation of clinical use, rather than the five-document donation set. Mixing the two sets is a common cause of requests for correction, because the reviewing officer matches the documents to the situation actually declared rather than to the situation the applicant had in mind.

Insight four: donated goods must never enter commercial channels. Article 6.2.4.1 c) requires the technical director to ensure that medical samples, donated goods and any property of a public institution are not sold. Read with Article 2.1, under which non-commercial activities also fall within the scope of the regulation, this means that donated devices must be traceable from import through to final disposal. Without such a record, the inconsistency is exposed in an unannounced inspection under Article 6.5.1 d).

4. Practical recommendations

• File donation projects under Article 6.4.2 a), item 7, and assemble all five donation documents required by item e) before submission.
• Schedule gazette publication as a separate preceding step, since it does not run within the SRS review period.
• Use the sworn declaration for the import of samples and the clinical use application for samples, and do not substitute the five-document donation set.
• Record the movement of donated goods from import through to disposal, so that no part of the consignment can reach a commercial channel.
• Attach the six items of general technical information, including proof of country of origin or authorisation of use by an international reference body.
• Where the recipient is a public institution, add the purchase order or awarded contract together with the DUI or NIT.

5. Verification checklist

• □ All five donation documents assembled
• □ Gazette publication built into the schedule as a preceding step
• □ Additional documents for samples distinguished from those for donations
• □ Traceability mechanism for donated goods established
• □ Six items of general technical information attached
• □ Purchase order and tax identification documents attached where the recipient is a public institution
• □ Recipient institution and intended use recorded consistently across all five documents

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