Used, remanufactured and refurbished biomedical equipment: seven requirement groups

1. Key takeaways

Article 6.4.3 of RTS 11.03.02:21 sets seven groups of requirements for authorisation to use used, remanufactured and refurbished biomedical equipment:

a) Technical information, covering a description of use and functioning together with the main systems and subsystems; a technical evaluation certificate or report issued by a competent entity or professional, detailing at least the key operating specifications and conformity with international quality standards by brand and model; and labelling showing manufacturing date, serial number, name, code, model and manufacturer. b) The name and location of the health service institution where the equipment will be installed, or an undertaking to notify them. c) A list of the accessories, consumables or spare parts supplied with the equipment. d) The equipment must be no more than five years old from the date of manufacture, extendable following assessment by the authority. e) Five declarations from the manufacturer or its representative in El Salvador. f) A declaration of the names and countries of the original manufacturer, the party that remanufactured or refurbished the equipment and, where applicable, any intermediary supplier. g) All importers, distributors and owners must accept vigilance requirements.

The article is unusual in the regulation in that it regulates equipment rather than a product type, and it does so at the point of authorisation to use rather than at the point of registration. The documentation therefore has to describe a specific machine, its history and its support arrangements, not a model in the abstract.

2. Legal basis

The requirements, the three definitions that determine which requirement set applies, and the interaction with the vigilance regulation are set out below.

The provisions cited in this article are Articles 3.18, 3.19, 3.20, 6.4.2 e) and 6.4.3 a)–g) of RTS 11.03.02:21, Dispositivos Médicos. Requisitos para la Regulación Sanitaria de Dispositivos Médicos (Acuerdo No. 14-2022, Diario Oficial No. 156, Tomo No. 436, 2022-08-23), and RTS 11.03.04:23, Vigilancia Postcomercialización de Dispositivos Médicos. Tecnovigilancia (Acuerdo No. DN.05.2024, Diario Oficial No. 68, Tomo No. 443, 2024-04-12).

Regulatory information verified as at 29 October 2026.

3. Expert insights

Insight one: the five years run from the date of manufacture, not from first use or the last refurbishment. Article 6.4.3 d) reads that the equipment must not be more than five years old from its manufacture. Read alongside the definition of remanufacturing in Article 3.18, which covers processing, refurbishing, updating, repackaging, repair or any other activity that significantly changes performance, safety specifications or intended use, the consequence is that refurbishment does not reset the five-year clock. This is the point most often misjudged by exporters of used equipment, who treat a recent overhaul as though it renewed the age of the machine.

Insight two: the three conditions each have a definition, and the right word must be chosen at filing. Article 3.20 defines used equipment as equipment that has been employed in a health service, remains within its service or operating life, has not had its functional structure altered, and requires calibration, maintenance, repair and operator training. Article 3.18 defines remanufacturing as processing that significantly changes performance or safety specifications. Article 3.19 defines upgrading as replacement of major subsystems with new parts by the manufacturer or an authorised refurbisher, conforming to the manufacturer’s specifications and to the safety standards applicable at the time of construction. The three definitions correspond to different depths of technical evaluation, so the label chosen determines the evidence required.

Insight three: the five declarations in item e) bring the manufacturer into the used-equipment transaction. The declarations must state that the equipment is not experimental; the indications and use; that the declarant is able to supply consumables, parts, spare parts and maintenance services over the service life of the equipment; that training programmes and mechanisms will be provided for operators and for maintenance engineers or technicians; and that operating, installation and maintenance manuals will be provided in the original language and in Spanish. The last of these is a real localisation workload for a Chinese manufacturer, and it is a documentary obligation rather than a recommendation.

Insight four: item g) brings importers, distributors and owners of used equipment within vigilance. The provision requires all importers, distributors and owners of used, remanufactured or refurbished equipment to comply with any vigilance requirement set by the authority under this regulation and under the vigilance regulation once in force. RTS 11.03.04:23 was published on 2024-04-12, so the obligation is now operative. Used equipment does not escape vigilance on the grounds that it is not a new product.

4. Practical recommendations

• Verify the manufacturing date first and confirm that the equipment is within five years of manufacture; where it is outside that window, apply for assessment and extension by the authority.
• Select the correct status term under Articles 3.18, 3.19 and 3.20, and match the technical evaluation to the depth that term implies.
• Commission the technical evaluation report from a competent entity or professional, setting out key operating specifications and conformity with international standards by brand and model.
• Request the five declarations under item e) from the manufacturer at the outset, and allow lead time for the Spanish-language manuals in particular.
• Declare the three parties required by item f): the original manufacturer, the remanufacturing or refurbishing party, and any intermediary supplier.
• Fold used equipment into the existing vigilance system rather than treating it as exempt because it is not new.

5. Verification checklist

• □ Manufacturing date verified and within five years, or an extension has been applied for
• □ Status term selected under Article 3.18, 3.19 or 3.20
• □ Technical evaluation certificate or report obtained
• □ All five manufacturer declarations in place, including Spanish-language manuals
• □ Names and countries of the three parties declared
• □ Equipment included within the vigilance system
• □ Labelling shows manufacturing date, serial number, name, code, model and manufacturer
• □ Accessories, consumables and spare parts list prepared

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Salvadoran market. Our team manages Ministry of Health (MINSAL) sanitary registration applications, prepares Spanish-language dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com