Ecuador Medical Device Legal Documentation Package: Articles 13, 23 and 25 under Resolución ARCSA-DE-2026-003-DASP

1. Key takeaways

The core rules for the legal documentation package of Ecuador are concentrated in three articles of the Alternative Technical Health Regulation for the Sanitary Registration, Control and Surveillance of Medical Devices for Human Use. Article 13 governs the language and legalisation requirements for foreign legal documents, Article 25 governs the additional data required for imported products, and Article 23 governs the minimum information that must be declared in the application form. Three key requirements frame the whole package: legal documents must be drawn up in Spanish or English; they must be legalised by apostille or by consular legalisation; and where the issuing authority makes the document verifiable on its official website, legalisation is waived.

The practical estimate used by GRZAN when planning an Ecuadorian submission is simple: the legal package is the layer of the dossier that reviewers check first, because the trade name, the manufacturer identity and the product codes declared in the application form under Article 23 are cross-checked against every legal attachment. Any mismatch between the application form and one of the legal documents is a direct trigger for a correction request, so the package should be treated as a single internally consistent set rather than as a pile of independent certificates.

2. Legal basis

The regulation Resolución ARCSA-DE-2026-003-DASP was signed on 2026-04-28 and enters into force on 2027-01-28. Article 9 establishes the one-product-one-application principle, Article 10 allows multiple entries within an application form up to a ceiling of 100 devices or 50 in vitro diagnostics, Article 12 sets the language rule for the technical file, and Article 13 sets the parallel rule for legal documents, including the legalisation and verification regime described below.

3. Expert insights

Insight one: the verification-in-lieu-of-legalisation rule of Article 13 is the most useful relaxation introduced by this revision. The text provides that where the information contained in a legal document issued by a foreign competent authority can be verified through the official website of that authority, ARCSA accepts the document without apostille or consular legalisation. For issuing authorities that have already digitised their certificates and operate an online verification service, this rule can remove the entire legalisation chain. Note carefully that what is waived is the legalisation step, not the submission obligation — the document must still be filed with the application.

Insight two: the nearest-consular-office rule of Article 13 closes a practical dead end. Where the country of origin has no Ecuadorian consular post, the document must be legalised at the nearest Ecuadorian consular office. This gives companies in countries with a sparse consular network a clear and defensible route instead of leaving the point open to reviewer interpretation.

Insight three: the 10 declared items of Article 23 are the master index of the package. They are: a valid operating permit number; the trade name; the common, generic or scientific name; the device type; the risk class; the commercial presentation and/or model or reference number; the name, city and country of the manufacturer or primary manufacturer; the product owner; the qualitative and quantitative formula where applicable; and the service life where applicable. These 10 items are the baseline against which ARCSA checks the consistency of every attachment — any discrepancy between an attachment and the application form can trigger a correction.

Insight four: Article 9 establishes the one-product-one-application principle. The applicant must file a separate application for each individual device. Multi-model products should use the entry limits of Article 10 — 100 entries for devices and 50 for in vitro diagnostics — within a single application form, rather than merging several products into one declaration.

Insight five: legal and technical documents share the same language rule but not the same legalisation rule. Article 12 requires the technical file to be in Spanish or English and to be accompanied by a list electronically signed by the Ecuadorian technical responsible person; Article 13 requires legal documents to be in Spanish or English and to be legalised. The legalisation requirement applies only to legal documents; technical documents are not legalised.

4. Practical recommendations

1. Prefer electronically verifiable documents: request certificates of free sale and similar legal documents that carry an online verification code on the issuing authority website, and invoke Article 13 to claim the legalisation exemption explicitly in the cover letter.
2. Cross-check against the 10 items of Article 23: confirm that the power of attorney, the certificate of free sale, the technical file and the application form state exactly the same trade name, manufacturer identity and model references.
3. Plan legalisation and translation in parallel: documents that are not in Spanish or English must be translated by a certified translator or an authorised translation centre, and the translation must faithfully match the original.
4. Split applications under Article 9: file one application per product while filling the entry limits of Article 10 within each form, avoiding duplicate fees for the same scope.
5. Have the technical file list electronically signed by the Ecuadorian technical responsible person, and preserve the signature chain evidence for the record.

5. Verification checklist

• □ Legal documents are available in a Spanish or English version.
• □ It has been confirmed whether each document can be verified on the official website of the issuing authority, which decides the legalisation exemption.
• □ Documents that cannot be verified online have completed apostille or consular legalisation.
• □ Documents not in Spanish or English have been translated by a certified translator or an authorised translation centre.
• □ Every attachment has been cross-checked for consistency against the 10 declared items of Article 23.
• □ Applications have been split under the one-product-one-application rule of Article 9.
• □ The technical file list has been electronically signed by the Ecuadorian technical responsible person.

Regulatory information verified as of October 29, 2026

GRZAN supports manufacturers, importers and authorised representatives building the legal documentation package for medical device registration in Ecuador, from Article 13 legalisation strategy and Article 23 consistency mapping to application splitting and translation management. For tailored assistance with your Ecuador medical device registration, contact us at info@grzanglobal.com.