Transport licence under Article 18: special transport conditions, vehicle data and fees

1. Key takeaways

When transporting biomedical equipment, IVDs and other health-related devices that require special conditions, a separate transport sanitary licence must be obtained in addition to the premises licence. Article 18 of Acuerdo No. 0631-ARSA-2023 provides that, in order to prevent the safety, quality and performance of devices from being adversely affected during transport and storage by shock, vibration and fluctuations of temperature and humidity, and having regard to the instructions and information provided by the manufacturer, the transport operator must submit 8 documents. The vehicle information item of the application is subdivided into 7 fields: brand, model, vehicle type, engine number, VIN or chassis number, year and licence plate number. A current annual vehicle inspection voucher (boleta de revisión vigente) must also be submitted, together with photographs of the vehicle from the front, side and rear. Fees are tiered by vehicle type and term (Acuerdo No. 003-2021, item QUINTO); the processing deadline is 15 working days online and 60 working days on-site.

2. Legal basis

Article 18 of the regulation and item QUINTO of the fee instrument together define when a transport licence is required, what vehicle data must be declared and how the fee scales. The table below consolidates the applicable provisions.

3. Expert insights

Insight 1: the transport licence is issued per vehicle, not per company. Article 18(1)(i) writes the 7 fields of brand, model, type, engine number, VIN or chassis number, year and licence plate into the application, in essence creating a regulated object for every single vehicle. Replacing, adding or retiring a vehicle directly triggers a licence modification; there is no rule that a company holding a licence may transport with any vehicle it likes.

Insight 2: the trigger is transport requiring special conditions, not all transport. The wording of Article 18 applies when the goods transported are biomedical equipment, IVDs and other health-related devices that require special transport conditions. The judgement rests on the manufacturer’s instructions and the characteristics of the device (cold chain, shock protection, humidity protection and so on). Article 11, item 5 accordingly requires premises to be equipped with technical equipment securing the storage and transport conditions fixed by the manufacturer; the two obligations interlock.

Insight 3: fees rise along two dimensions, vehicle type and term. Item QUINTO of Acuerdo 003-2021 prices three vehicle classes (Pick up, Camión, Furgón or Remolque) across the three validity tiers of 2, 4 and 6 years; for example, a Camión online is 1/6, 1/4 and 1/3 of the average minimum wage. The larger the vehicle and the longer the term, the higher the fee, which differs from the per-activity accumulation logic of premises licences: transport is priced per vehicle and per tier.

Insight 4: the online versus on-site gap is fourfold. For the same transport licence, online processing takes 15 working days and on-site processing 60 working days. For time-sensitive businesses such as cold-chain equipment, the choice of channel is itself part of the supply chain decision.

Insight 5: the inspection voucher is annual and not synchronised with the 2/4/6-year licence cycle. Article 18, item 6 requires proof of payment of the tasa única anual vehicular (the inspection voucher) and that it be current. Even if a 6-year validity was chosen, the vehicle itself must keep its annual inspection in force; otherwise the factual basis on which the licence rests changes.

4. Practical recommendations

• Determine necessity first: check the transport and storage conditions in the manufacturer’s IFU and confirm whether special transport conditions apply, to avoid over-licensing for ambient, routine consumables.
• Build a per-vehicle ledger: consolidate the 7 fields, the inspection expiry date and the licence expiry date of every vehicle into one asset table, and start a modification in parallel whenever a vehicle is replaced or added.
• Prefer online filing: a 15-working-day deadline against 60 working days is often decisive in cold-chain and tender-delivery scenarios.
• Consider the term together with vehicle age: the 6-year tier carries the highest fee but the lowest filing frequency; older vehicles fit the 2-year tier better, avoiding high-tier fees for vehicles due for retirement.
• Set the inspection voucher as an annual reminder: renew it every year even while the licence itself remains valid.
• Match modifications to the vehicle class: Pick up online modification 1/24, Camión 1/12, Furgón or Remolque 1/10, and Pick up on-site modification 1/50; verify the current fee table before filing.

5. Verification checklist

• □ A written determination has been made, based on the manufacturer’s instructions, whether the goods require special transport conditions
• □ The 7 fields for each vehicle have been recorded and match the vehicle registration documents verbatim
• □ The annual vehicle inspection voucher is current and set as an annual reminder
• □ Photographs of the vehicle front, side and rear have been provided as required by Article 18, item 7
• □ The validity tier (2/4/6 years) has been fixed according to vehicle class and age
• □ The online channel has been confirmed available and the 15-working-day deadline is built into delivery scheduling
• □ Modification triggers for vehicle replacement, addition and retirement are embedded in the fleet management procedure

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.