Refurbished and used biomedical equipment: authorisations, 5-year limits and labels

1. Key takeaways

Honduras maintains two separate authorisation regimes, one for refurbished (repotenciado) and one for used (usado) biomedical equipment. Articles 56 to 62 of Acuerdo No. 0631-ARSA-2023 govern refurbished equipment: authorisation is required before import, sale, conditioning, repair, export, storage, distribution, rental or lending, applied per import and per unit of equipment (Article 56); only the product owner or its authorised refurbisher may import and sell (Article 57); single-use devices are excluded (Article 58); the original design must not be altered, and replacement of major subsystems is permitted only with new parts approved by the product owner, the manufacturer or their authorised refurbisher (Article 59); Article 60 requires 5 guarantees, the first being no more than 5 years since manufacture (extension subject to ARSA assessment and approval); the equipment must not be advertised or sold as new (Article 61); and Article 62, item 8 requires a complementary label bearing the wording Equipo Repotenciado. Articles 63 to 67 govern used equipment: case-by-case application (Article 63); single-use devices excluded (Article 64); the importer and the registering company are responsible for function, effectiveness and safety (Article 65); no more than 5 years since manufacture (Article 66); and Article 67, item 6 requires a complementary label bearing the wording Equipo usado.

2. Legal basis

The two regimes sit side by side in Acuerdo No. 0631-ARSA-2023, from authorisation scope through guarantees to labelling. The table below consolidates the provisions for both tracks.

3. Expert insights

Insight 1: the 5-year rule is an absolute ruler measured from manufacture, shared by both regimes. Article 60, item 1 and Article 66 both write the cap as cinco (5) años de servicio desde su fabricación. The starting point is the date of manufacture, not the date of first use and not the date of the last refurbishment. Pre-purchase due diligence must therefore obtain proof of the year of manufacture rather than judging by cosmetic condition. Both articles also leave a door open: extension requires ARSA assessment and approval (refurbished) or assessment and authorisation (used).

Insight 2: the authorisation logic differs between refurbished and used equipment. Refurbished emphasises the chain of rights: Article 57 permits import and sale only by the product owner or its authorised refurbisher. Used emphasises the chain of responsibility: Article 65 places the guarantees of function, effectiveness and safety squarely on the importer and the registering company. The former requires securing authorisation documents; the latter requires demonstrated verification capability.

Insight 3: the two labels are public status declarations, not internal marks. Article 62, item 8 and Article 67, item 6 both require the wording Equipo Repotenciado or Equipo usado on the complementary label (etiqueta complementaria). Combined with the 11 requirements for complementary labels in Article 84, Section 2, the refurbished or used status of the equipment is mandatorily visible while it circulates on the market, closing the loop with Article 61, which prohibits advertising or selling it as new.

Insight 4: single-use devices are excluded by both regimes simultaneously. Article 58 (refurbished) and Article 64 (used) both exclude devices designed for single use: the former stressing that by their nature they should not be reprocessed, repaired or refurbished, the latter stressing single use as defined by the product owner. This reinforces each other with Article 84, Section 1(j), which requires labels to carry the single-use statement.

Insight 5: the 5 guarantees turn after-sales capability into a market-entry condition. Article 60 requires not only that the equipment works well but that the refurbisher or importer can guarantee the supply of new consumables, spare parts and components, technical support and maintenance and repair capability, and in-country training for operators and maintenance managers. In other words, a trader without local service capability cannot serve as the registering entity for refurbished equipment.

4. Practical recommendations

• Obtain proof of the year of manufacture before purchase: write the rule of no more than 5 years since manufacture into the purchase contract and acceptance criteria, and keep over-age equipment out of the container.
• Settle the chain of rights first for refurbishment projects: secure the refurbishment authorisation issued by the product owner, or have the product owner itself act as importer and seller (Article 57).
• Build verification capability first for used-equipment projects: prepare verification plans and records for function, effectiveness and safety under Article 65, with responsibility resting on the importer and the registering company.
• Lay out the labels in advance: reserve the wording Equipo Repotenciado or Equipo usado on the complementary label and satisfy the 11 requirements of Article 84, Section 2 at the same time.
• State the installation site in the application: used equipment must name the medical institution and address where it will be installed (Article 67, item 4), and refurbishment applications must list accessories, consumables and accompanying documents (Article 62, items 9 and 10).
• Where equipment genuinely exceeds 5 years, raise the assessment request with ARSA at project initiation instead of waiting until customs clearance.

5. Verification checklist

• □ Proof of manufacture date obtained for every unit and no more than 5 years since manufacture
• □ For refurbishment projects, authorisation documents from the product owner or its authorised refurbisher are secured
• □ For used-equipment projects, verification plans for function, effectiveness and safety are ready
• □ The complementary label carries the wording Equipo Repotenciado or Equipo usado
• □ Labels show manufacture date, serial number, name, code, model and manufacturer
• □ Name and place of the installing institution for used equipment are fixed and written into the application
• □ Supply of consumables and spare parts, technical support and in-country training are secured (Article 60)

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.