Sanitary Authorisation Required Before Import

1. Key takeaways

Acuerdo No. 0631-ARSA-2023, the Regulation for the Sanitary Control of Medical Devices and Other Devices of Sanitary Interest, states in Article 33 that a device must hold a valid sanitary authorisation before it is imported, repackaged, exported, repaired, stored, transported, distributed, sold, rented, lent and/or advertised, and that a risk classification report (Informe de Clasificación por Riesgo Sanitario) must be obtained before applying for the ARSA sanitary registration; the registration application may be submitted from the date of issue of the classification report or of its extension, so that classification and registration are joined in time. Article 34 then places a prohibitive rule on the same list of activities: anyone who does not hold the corresponding ARSA sanitary authorisation may not engage in any of these activities. The GRZAN regulatory team notes that the two articles together cover 11 categories of activity, of which export and repair are the most frequently overlooked; moreover, Article 34 is a prohibitive provision, so a violation feeds directly into the penalty track of Article 37 and cannot be resolved by simply supplying a missing document.

• Article 33 requires a valid sanitary authorisation before any of 11 regulated activities.
• A risk classification report must precede the sanitary registration application.
• Article 34 prohibits unauthorised entities from carrying out any listed activity.
• Export and repair are the two activities most often missed by applicants.
• Violations are penalised under Article 37 rather than corrected administratively.

2. Legal basis

The provisions below are drawn from the regulation and from the Health Code, and together they define the boundary between lawful and unlawful handling of devices before and after registration.

3. Expert insights

Insight one: Articles 33 and 34 are two sides of the same list. Article 33 says the authorisation must be held first, while Article 34 says no one may act without it. The practical effect for companies is that the list of 11 activities is the compliance boundary itself — once an activity falls within the list, there is no room for acting first and regularising later. The inclusion of advertising in particular brings market pre-launch promotion inside that boundary as well.

Insight two: export is written into the list of authorised activities, and this is the easiest point to miss. In Article 33, exportación follows immediately after the first item. For companies that use Honduras as a Central American transit warehouse, the export leg equally requires authorisation, and it cannot be skipped on the grounds that the goods are merely in transit or trans-shipment. The prohibition in Article 34 applies to export in the same way as to every other activity on the list.

Insight three: the second paragraph of Article 33 is a hard constraint on the timeline. The provision does not merely say classification must precede registration; it further specifies that the registration application may be submitted from the date of issue of the classification report or of its extension. Combined with the 6-month validity under Article 31, this creates in practice a two-stage clock: the classification report is issued, then within 6 months — or within a further 6 months after an extension — the registration application must be filed. If either stage runs out of time, the process has to start again.

Insight four: the consequence of breaching Article 34 runs through Article 37, not through correction. Article 37 provides that the corresponding penalties apply to those who carry out these activities with an expired authorisation or with no authorisation at all; Article 36 in turn empowers ARSA to verify the safety and efficacy of confiscated, abandoned, illegally entered or unregistered devices and to decide on their donation or destruction. Together these articles show that the power to dispose of unauthorised products rests with ARSA, and the company should not expect to retain any claim over the goods.

Insight five: an authorisation and a licence are not the same thing, and both must be in place at the same time. The sanitary authorisation required by Article 33 corresponds in the system to the 13 control instruments of Article 5, while premises and vehicles are covered separately by the sanitary licence of Article 12 and the transport licence of Article 18. The GRZAN regulatory team recommends building a three-cell matrix — product registered or not, premises licensed or not, transport licensed or not — and treating any empty cell as a stop signal for the corresponding action.

4. Practical recommendations

• Build a compliance boundary checklist from the 11 activities in Article 33 and confirm, item by item, that the corresponding authorisation is in place.
• Bring export and repair operations into the authorisation plan; do not exclude them on the assumption that the flow is outbound only or that the goods are merely being repaired.
• Start a countdown from the date of issue of the classification report and make sure the registration application is filed within 6 months, or within 6 months after an extension.
• Maintain a three-cell matrix of product registration, premises licence and transport licence, and stop any action for which a cell is empty.
• Do not schedule shipments of unauthorised products, so as to avoid the confiscation and destruction track under Article 36.
• Tie market pre-launch scheduling to registration progress, and run no advertising before authorisation is granted.

5. Verification checklist

• □ A compliance boundary checklist covering the 11 activities of Article 33 has been established
• □ Export and repair operations are included in the authorisation plan
• □ The date of issue of the classification report has been set as the start of the registration countdown
• □ The three-cell matrix of product registration, premises licence and transport licence is in place and maintained
• □ No unauthorised products are scheduled for shipment
• □ Market pre-launch scheduling is tied to registration progress

Further reading: [Article 12 — Three authorisations in order](/honduras-medical-device-registration/three-authorisations-in-order/) | [Article 13 — Risk classification report, six months](/honduras-medical-device-registration/risk-classification-report-six-months/) | [Article 04 — Scope: 15 regulated activities](/honduras-medical-device-registration/scope-fifteen-regulated-activities/)

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