Legalisation and Spanish versions for Foreign Documents: Article 6.3.2.1

1. Key takeaways

The closing paragraph of article 6.3.2.1 of RTS 11.03.02:21 sets the threshold for foreign documents in a single sentence: every official or legal document issued abroad must be legalised (legalizarse) in accordance with national rules. The sentence sits after the list of twelve general requirements, which means it governs the dossier as a whole rather than any one item within it.

Read with article 6.3.2.1 c) and d), which require the CVL and the GMP certificate, both normally issued by an authority or a certification body outside El Salvador, the provision falls in practice on the two documents most likely to create difficulty. Item f), the manufacturing or maquila contract, adds a third case where the contract is signed abroad.

The sentence is easy to pass over because it has no letter of its own and no heading. It applies nonetheless to every annex in the file that originates with a public body or with a notary outside the country, and it applies before the file is examined rather than after a query is raised. An applicant who treats legalisation as a correction to be made later will usually lose the review slot, because the acceptance stage checks the formal completeness of the annexes before any technical assessment begins.

• Legalisation applies to the whole dossier, not to a single annex.
• Official and legal documents issued abroad are the ones caught by the rule.
• CVL and GMP certificates are the two most frequently affected documents.
• A manufacturing or maquila contract signed abroad falls under the same rule.
• Legalisation does not replace translation: Spanish remains a separate obligation.
• Dossier documents must remain valid, so legalisation timing matters.

2. Legal basis

The obligation is short in the regulation and long in its consequences. The table records the provision itself, the documents it most often touches, the reliance provision that offers a parallel route, and the labelling article that creates the separate language obligation.

3. Expert insights

First insight: legalisation and Spanish translation are two separate operations, each with its own provision. The closing paragraph of article 6.3.2.1 requires legalización, the confirmation of the legal force of a document, while article 6.3.4 d) requires labels in Spanish or in ISO 15223-1 symbols, the confirmation of readability. The two point at different review dimensions, and the usual error is to treat notarisation and consular legalisation as the end of the documentary work, only to file a label and instructions for use that are still in English or Chinese. Neither operation substitutes for the other, and neither is complete without the other where both are engaged.

Second insight: legalisation reaches official or legal documents, not every foreign-language item in the file. The wording is todo documento oficial o legal emitido en el extranjero, that is, official or legal documents. The CVL, the BPM or ISO 13485 certificate, the power of attorney (poder) between the registration holder and the professional responsible, and the manufacturing or maquila contract belong to that class. The technical datasheet, the risk management report and the validation reports prepared by the manufacturer are not official documents, but they still need a Spanish version. The two classes follow different processes, and mixing them either over-notarises technical annexes or leaves certificates unlegalised.

Third insight: on the reliance route, the obligation does not disappear because a document is verifiable. Section 6.6 of the reliance policy is drafted as todo debe ser comprobable o debidamente legalizado, everything must be verifiable or duly legalised, and the conjunction is disjunctive. That creates two paths: where the approval of the reference authority can be checked on a public web page, the verifiable path is available; where it cannot, legalisation is still required. The choice should follow the type of evidence rather than habit, since defaulting to notarisation for every document adds cost and delay without adding value.

Fourth insight: legalisation takes time, and documents expire. Consular legalisation and apostille are usually measured in weeks, while article 6.3.1 e) requires dossier documents to remain valid. An applicant who legalises first and then waits for a CVL to expire ends up with a legalised but invalid document. GRZAN confirms that the validity of a document covers the whole review cycle before starting legalisation, so that the two clocks run in the same direction rather than against each other. The sequencing decision is therefore twofold: decide which documents actually need legalisation, then decide when to start each one so that the legalised version is still valid on the day it is read.

A dossier register that records, for every annex, whether the document is official or self-prepared, whether it is legalised or verifiable, and when it expires, turns this administrative exposure into a visible workstream. In a multilingual file it is also the simplest way to spot the annexes that are still in their original language or still waiting for a consular stamp while the technical drafting has already moved ahead.

4. Practical recommendations

• Classify dossier materials first into official or legal documents and self-prepared technical documents, and process each class separately.
• Legalise official and legal documents, and prepare Spanish versions for self-prepared technical documents.
• Produce the Spanish label and instructions for use independently, without relying on the language of the notarised set.
• On the reliance route, decide between the verifiable path and the legalisation path rather than notarising everything by default.
• Confirm that a document remains valid across the whole review cycle before starting legalisation.
• Carry the legalisation lead time in the project schedule, because it sits outside the review period of the regulator.

5. Verification checklist

• □ Dossier materials classified as official documents and self-prepared documents
• □ Official documents legalised
• □ Spanish versions prepared for self-prepared technical documents
• □ Label and instructions for use in Spanish
• □ Reliance route chosen as verifiable or legalised
• □ Document validity covers the review cycle

The regulations cited in this article are 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), articles 6.3.1 e), 6.3.2.1 c), d), f) and closing paragraph, and 6.3.4 d); and the Política de Aplicación de Reliance (01.01.02.POL.20250508.01, Versión No. 01, SRS website, 2025-05-08), section 6.6.

Regulatory information verified as at 29 October 2026.

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