Establishment relocation and infrastructure changes

1. Key takeaways

Article 6.2.3 of RTS 11.03.02:21 sets the rule on establishment changes in a single sentence: any change of domicile or infrastructure at an establishment authorised by the authority requires prior application for approval. The provision does not distinguish between major and minor changes, and it creates no exemption. Any change of domicile or infrastructure falls within it.

Read with Article 6.2.2 a), under which the application file includes a floor plan and a location sketch, and with Article 5.3.2, under which the quality system must cover the activities actually carried out, a relocation touches three things at once: the establishment registration, the approved floor plan and the scope of the quality system.

The practical consequence is that relocation is a regulatory project with a lead time, not a facilities decision that is reported afterwards. The approval has to exist before the move, and the technical director carries a parallel reporting duty under a different provision.

2. Legal basis

The approval requirement, the documents that support it, the parallel reporting duty and the applicable fees are set out below.

The provisions cited in this article are Articles 5.3.2, 6.2.1 g), 6.2.2 a), 6.2.3 and 6.2.4.1 e) 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 Articles 11.3.2, 11.4.3, 11.6.1 and 11.6.2 of the Tarifario de la Superintendencia de Regulación Sanitaria (2025 edition, published on the SRS website in 2025-10).

Regulatory information verified as at 29 October 2026.

3. Expert insights

Insight one: prior is the operative word, and there is no route to regularise afterwards. Article 6.2.3 is worded so that approval must be applied for in advance. The provision leaves no space for retrospective ratification and sets no threshold of significance. The practical result is that even a move to a different unit in the same building requires an application first. Moving and then notifying is treated as an unapproved change, which places the establishment’s authorisation in question at the very moment when it also has to demonstrate continuity of its storage and distribution arrangements.

Insight two: a single relocation triggers more than one fee. Article 11.4.3 of the Tarifario prices the relocation of a device importer at USD 72.00, and Article 11.6.1 prices floor plan review for a new facility, a relocation or an infrastructure remodelling at USD 240.00. For a manufacturing establishment, Article 11.3.2 prices relocation or remodelling at USD 480.00. A pure importer and a manufacturing laboratory are therefore subject to different line items, and the budget has to be built according to the category of establishment rather than from a single template.

Insight three: the technical director’s reporting duty is a parallel second track. Article 6.2.4.1 e) requires the technical director to report process and facility changes that affect device quality to the authority. This is a different obligation from the prior approval in Article 6.2.3: the one is an ongoing reporting duty attached to a named individual, the other is a one-off authorisation attached to the establishment. A remodelling project has to run along both tracks, and completing the establishment application does not discharge the reporting duty, nor the reverse.

Insight four: infrastructure changes reach into the scope of the quality system. Article 5.3.2 requires the quality system to cover the activities the establishment actually carries out, and Article 6.2.1 g), item 1, requires the establishment to have facilities and technical personnel appropriate to the nature of the products and the activities to be performed. If a remodelling changes storage conditions, for example by adding cold storage, or changes the range of activities, for example by adding repackaging, then both the quality system documentation and the scope described in the system certificate must be updated in step.

4. Practical recommendations

• Submit the application under Article 6.2.3 before any relocation or remodelling, rather than moving first and notifying afterwards.
• Budget the relocation fee by establishment category, at USD 72.00 for an importer or USD 480.00 for a manufacturing laboratory, together with the USD 240.00 floor plan review fee.
• Have the technical director report process and facility changes affecting quality at the same time, under Article 6.2.4.1 e).
• Where the remodelling affects storage conditions or the range of activities, update the quality system documentation and the certificate scope in parallel.
• Update the floor plan showing total area and the location sketch so that they match the application file exactly.
• Write the relocation approval into the lease as a condition precedent to the lease taking effect.

5. Verification checklist

• □ Prior approval obtained for the relocation or remodelling
• □ Relocation fee and floor plan review fee calculated
• □ Technical director’s change report submitted
• □ Quality system documentation and certificate scope updated
• □ Floor plan and location sketch updated
• □ Lease agreement conditional on the approval
• □ Establishment registration details amended to reflect the new address

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