Apostille and Consular Legalisation Under DE 490 Article 35

1. Key takeaways

Foreign legal documents that are not in Spanish and that are submitted in order to obtain the technical standards certificate, the technical verification certificate and the operating licence must be authenticated under Article 35 of Decreto Ejecutivo N° 490. Where the country of provenance is a party to the Hague Convention, authentication takes the form of an apostille under Ley No. 6 of 25 June 1990, the law by which Panama approved the convention. Where the country is not a party, the document must be authenticated by the local Panamanian diplomatic or consular officer and then by the Minister of Foreign Affairs of Panama; where no Panamanian mission exists, authentication is carried out by a diplomatic or consular representative of a friendly state and accompanied by a certificate from the Minister of Foreign Affairs. Catalogues (catálogos) are exempt from the requirement.

Two practical consequences follow. The applicable route is decided by the status of the country of provenance, not by the preference of the applicant, and the two routes differ substantially in duration. And the exemption for catalogues covers authentication, not translation, so a non-Spanish catalogue still falls to be assessed against the translation rule.

• Article 35 applies to foreign, non-Spanish legal documents filed for the CCT, the CVT and the operating licence.
• Hague Convention states: apostille under Ley No. 6 of 25 June 1990.
• Non-member states: consular authentication plus authentication by the Panamanian Minister of Foreign Affairs.
• Catalogues are expressly exempt from the authentication requirement.
• Non-Spanish originals require a Spanish translation by an authorised public translator of the Republic of Panama.

2. Legal basis

Article 35 of Decreto Ejecutivo N° 490 of 4 October 2019 is drafted in three paragraphs: the apostille route for member states, the consular route for non-member states with the catalogue exemption, and the translation requirement. Decreto Ejecutivo No. 1689 of 29 December 2020 added a temporary facility through Article 35-A.

The article is often misread as a single rule: the first paragraph covers member states and the integrity of the authenticated set, the second covers non-member states and carries the catalogue exemption, and the third governs language whatever route was used.

3. Expert insights

Insight one: the prohibition on opening the binding in order to photocopy is a formal requirement that is very easy to breach. The first paragraph of Article 35 states that the binding must not be released in order to photocopy it (El amarre no deberá soltarse para fotocopiarlo). What Panama accepts is an authenticated set that remains bound as one physical object. The most common error in practice is to open an authenticated set so that several copies can be made for filing, which leaves the documents eventually submitted without the integrity of authentication.

Insight two: the catalogue exemption is a substantial reduction in cost. The final sentence of the second paragraph of Article 35 exempts catalogues from this requirement (Se exceptúan este requisito para los catálogos). Product catalogues are usually long and exist in many versions, and authenticating each of them would be extremely expensive. The exemption recognises that a catalogue is a commercial document rather than a legal one. The limit of the exemption should be noted: it covers the authentication requirement, not the translation requirement, so whether a non-Spanish catalogue must be translated has to be assessed against the third paragraph of Article 35 and item 5 of Article 36 (practical estimate).

Insight three: Decreto Ejecutivo No. 1689 shows how Panama temporarily relaxes authentication in an emergency. Article 1 of that decree rewrote Article 35-A so that, for COVID-related devices, the manufacturer letter of commitment, the GMP or quality certificate, the certificate of free sale, the ISO 13485 certificate and the manufacturer support letter could initially be replaced by a letter of commitment notarised by a Panamanian notary, with the formal authenticated documents filed within 180 working days after issue of the CCT. Article 4 limited the facility to the duration of the national state of emergency. The provision has lapsed with the emergency, but it reveals a mechanism: Panama recognises that authentication is a bottleneck in the supply chain and has provided an emergency channel for it.

Insight four: the apostille rule depends on the membership status of the country of provenance, so that status has to be checked before the route is fixed. The first and second paragraphs of Article 35 turn on whether the country of provenance is a party to the Hague Convention. Mainland China has been a party since 7 November 2023 (practical estimate, to be confirmed against the official HCCH membership list), while Hong Kong and Macao are earlier members. A company should verify the current membership status of the country of provenance before scheduling, and only then decide between the apostille and the consular route, because the difference in lead time between the two is large.

4. Practical recommendations

• At project start, check whether the country of provenance is a party to the Hague Convention, and fix the authentication route on that basis.
• Keep authenticated sets bound and intact, and never open a seam seal in order to photocopy; where several sets are needed, obtain several authentications.
• Rely on the catalogue exemption in the second paragraph of Article 35 and do not authenticate catalogues.
• Arrange translation of non-Spanish legal documents by an authorised public translator of the Republic of Panama in parallel with authentication, as required by the third paragraph of Article 35.
• Treat authentication as a separate workstream and start it early, running it in parallel with dossier drafting rather than after it.
• Where the consular route applies, budget for two authentication steps in sequence.

5. Verification checklist

• □ Membership of the Hague Convention confirmed for the country of provenance under the first or second paragraph of Article 35
• □ Apostille seal and document binding intact, with the seam seal unopened
• □ Non-member state documents authenticated by consular officer and by the Minister of Foreign Affairs
• □ Catalogues treated as exempt and not authenticated
• □ Non-Spanish documents translated by an authorised public translator of the Republic of Panama
• □ Electronic authentication method recorded where a method recognised under an international agreement is used
• □ Authentication completed for every document required under the CCT, CVT and operating licence routes

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

Regulatory information verified as of 29 October 2026.