Establishment obligations and the 30-working-day closure notice

1. Key takeaways

Obtaining the licence is only the starting point. Article 11 of Acuerdo No. 0631-ARSA-2023 imposes 6 continuing obligations on the establishment (or the person responsible for it): maintain facilities and professionals with a technical-scientific background proportionate to the nature of the products and the activities carried out; supervise the circulation of devices and keep an electronic distribution record to guarantee traceability; maintain accurate inventory and rotate stock in a manner that does not impair quality, safety and performance; provide information on device stocks when required; maintain the technical equipment needed to secure the storage and transport conditions fixed by the manufacturer, especially for products requiring special preservation conditions; and delimit the establishment’s activities according to the scope ARSA has defined for each class of authorisation. Two further provisions are hard constraints: Article 15 prohibits operating without a valid licence or carrying out activities and services not expressly approved on the licence; and Article 16 requires the owner or legal representative of the establishment to notify ARSA within 30 working days of a temporary or permanent closure, with an ARSA inspection before reopening and a prior modification application where the activities stated on the licence have changed.

2. Legal basis

The obligations of the licence holder rest on a cluster of articles of Acuerdo No. 0631-ARSA-2023 covering premises duties, prohibitions, closure, display, the technical director, suspension and sampling costs. The table below consolidates them.

3. Expert insights

Insight 1: the electronic distribution record is where traceability lands. Article 11, item 2 does not stop at keeping a ledger; it expressly requires an electronic record of distribution. This echoes the definition of Trazabilidad in Article 3, Section II, the ability to identify the origin, flow and location of a specific unit or batch or serial number, and it determines how fast a company can respond in vigilance and recall scenarios.

Insight 2: stock rotation is written as a quality obligation. Article 11, item 3 requires accurate inventory and provides that rotation must take place under conditions that do not impair the quality, safety and performance of the devices. For shelf-life-sensitive products, including the categories subject to the Article 74 requirement of at least 9 months of remaining shelf life at import, rotation rules belong in the SOPs, not merely in financial first-in-first-out practice.

Insight 3: closure is a notification duty, not an internal decision. Article 16 brings both temporary and permanent closure within the 30-working-day notification scope and requires an ARSA inspection before reopening. The practical cost is that after notifying closure, resuming operations requires another scheduled inspection, and that waiting time is pure cost.

Insight 4: the scope of activities is the core boundary of the licence. Article 11, item 6 requires the establishment’s activities to be delimited according to the scope ARSA has defined for each class of authorisation, forming a pair with the prohibition in Article 15: only what the licence states may be done, and anything beyond it is a violation. This explains why the fee tables of Acuerdo 003-2021 price the six activities of Acondicionar, Almacenar, Importar, Distribuir, Comercializar and Fabricar separately. The activity is the smallest unit of the licence.

Insight 5: obligations cascade down to the technical director. Article 11 opens with the titular or the authorised person responsible for the premises, while Article 9 requires the licence to be displayed prominently and a technical director appointed, and Article 10 lists that director’s 8 functions. Establishment obligations must therefore land on specific positions within the organisation, not rest formally on the legal entity alone.

4. Practical recommendations

• Break the 6 obligations into SOPs with named owners: facilities and personnel to HR and quality, electronic distribution records and stock rotation to warehousing, storage and transport conditions to equipment, and scope of activities to compliance.
• Make the distribution record electronic and searchable by batch or serial number, with fields covering at least product name, registration number, batch or serial number, quantity, consignee and date, to satisfy the definition of Trazabilidad.
• Establish rotation and near-expiry alert rules for shelf-life-sensitive categories, aligned with the 9-month remaining shelf life requirement of Article 74.
• Put closure, relocation, reconstruction and reopening into one change-trigger table: notify closure within 30 working days, apply for any modification first, and then await inspection before reopening.
• Review once a year whether the activities stated on the licence match the actual business; where an addition is needed, use the activity-expansion change of Article 20, item 7 with the additional fee under Article 22.
• When the technical director changes, process the change under Article 20, item 2 in parallel and ensure the 8 functions of Article 10 are handed over with written records.

5. Verification checklist

• □ The 6 establishment obligations have been broken into SOPs with responsible positions assigned
• □ The electronic distribution record system is live and searchable by batch or serial number
• □ Rotation and near-expiry alert rules are written into the warehouse operating documents
• □ The list of storage and transport equipment has been checked item by item against the conditions fixed by the manufacturer
• □ The annual review of licensed activities versus actual business scope has been completed
• □ Trigger and notification procedures for closure, relocation, reconstruction and reopening are in the management system (30 working days)
• □ The technical director is in post and displayed on the licence, with a valid professional card

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.