Special import authorisations AEG, AENG and AEP: channels, quantity caps and fees

1. Key takeaways

For devices not intended for commercialisation, Honduras provides a special import authorisation rather than a sanitary registration. Article 71 of Acuerdo No. 0631-ARSA-2023 divides the mechanism into two branches: the special import authorisation for devices (comprising three sub-types, AEP for personal use, AEG for government use and AENG for non-government use) and the special authorisation for donations. Article 72 lists the 9 categories of goods eligible for AEG; Article 73 lists the 9 categories for AENG and sets, at item 3, a cap of 10 units or items per product; Article 74 fixes for AEP a cap of 5 units or items per product for personal use, and requires imported devices to have a remaining shelf life of not less than 9 months (orphan devices included). The GRZAN regulatory team notes that the dividing line among the three is not the product but the importing entity and the purpose: for one and the same product, a government body imports under AEG, a non-government body under AENG and a private individual under AEP, each with its own rules and quantity caps.

2. Legal basis

The special import channels are defined by Articles 71 to 75 of Acuerdo No. 0631-ARSA-2023, with one verifiable fee entry in Acuerdo No. 012-2020. The table below consolidates the classification, caps, documents and timing rules.

3. Expert insights

Insight 1: the three channels are not risk classes but entity-plus-purpose routes. AEG (government), AENG (non-government) and AEP (personal) overlap heavily in the goods listed in Articles 72, 73 and 74; orphan devices, reference standards, laboratory garments, quality-control devices and medical-team equipment all appear in several. The real difference lies in who imports and for whose use. Choosing the wrong channel does not cost a tariff surcharge but the rejection of the authorisation or a blocked customs clearance.

Insight 2: quantity caps fall only on AENG and AEP; AEG has no unit cap. Article 73, item 3 caps non-government bodies at 10 units/items per product and Article 74, item 1 caps individuals at 5 units/items, both subject to exceptions that ARSA may otherwise provide; the 9 AEG categories of Article 72 carry no unit cap. This difference directly determines which entity should be the importer in humanitarian aid and medical-team projects.

Insight 3: the 9-month remaining shelf life is a cross-cutting requirement. Article 74, item 1, sub-item 2 and the second paragraph write the minimum validity of nine months into the general requirements for imported devices (ARSA may judge otherwise on technical grounds), and Article 75, item 5(d) repeats in the pro-forma invoice requirements that the shelf life must not be below 9 months. Article 76, item 6(a) of the donation channel uses the same figure. Nine months is thus the common threshold for both the special import and the donation routes.

Insight 4: research devices need a double sign-off of ethics approval plus ARSA authorisation. Article 72, item 9 requires the research protocol for research devices to have been approved by an ethics committee and authorised by ARSA. Among the additional documents of Article 75 for government and non-government applicants, devices for clinical trials require the sanitary licence number of the trial site, the authorisation number of the research project and the registration number of the ethics-scientific committee. This matches the logic of Article 86, under which clinical trials are assessed by CEIB of UNAH and approved by ARSA.

Insight 5: the AENG deadline and fee are the only ones verifiable from official text among the three. Item SÉPTIMO of Acuerdo No. 012-2020 gives the special authorisation for non-government bodies a deadline of 5 working days and a fee of 1/9 of the average minimum wage (online). The fee tables of the other categories in that Acuerdo, including new registrations and renewals, are published as images with no searchable text layer in the official PDF, so GRZAN does not cite those amounts; all amounts follow the payment notice issued by ARSA at the time.

4. Practical recommendations

• Fix the channel before preparing documents: lock in AEG, AENG or AEP according to the importing entity (government, non-government or individual) and the purpose, not according to the product category.
• Compute the quantity caps for non-government and personal imports (10 and 5) at project initiation; quantities above the cap require either splitting the importing entities or a written exception request to ARSA.
• Check remaining shelf life for every item before container loading: nothing below 9 months goes into the shipment unless ARSA has issued a technical judgement to the contrary.
• For research devices, run the ethics committee approval and the ARSA research authorisation in parallel from the start, and enter both numbers into the additional documents of Article 75.
• The label must carry the wording PROHIBIDA SU VENTA (Article 75, item 7); it may be printed on the primary or secondary packaging or submitted as a complementary label.
• For products containing controlled substances, apply in parallel to the DNPF for the controlled-substance import licence, with the technical sheet, safety sheet and technical director card attached.

5. Verification checklist

• □ Nature of the importing entity confirmed and the channel (AEG/AENG/AEP) selected
• □ Each imported item mapped to an applicable category of Articles 72/73/74
• □ Whether quantities touch the 10-unit or 5-unit cap has been calculated
• □ Remaining shelf life of every product is not less than 9 months
• □ Pro-forma invoices include consignee, product name, batch number, shelf life and quantity (multiple invoices consolidated)
• □ Labels carry the wording PROHIBIDA SU VENTA or a complementary label is prepared
• □ DNPF import licence for controlled substances (where involved) has been obtained

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.