GMP Attestation or GMP / ISO 13485 Certificate? What LATAM First-in-Human Trials Require, Stage by Stage

Short answer: Whether a signed manufacturer attestation is enough depends on the filing stage as much as the country. In Costa Rica, the ethics committee accepts a manufacturer’s statement of Good Manufacturing Practice (GMP) compliance. The customs-release step that follows requires an authority-issued GMP certificate. Panama and El Salvador accept a certificate or a declaration at regulator review. Chile asks for an official certificate for imported pharmaceutical products. Peru asks for a GMP certificate or a document that guarantees compliance.

Sponsors of first-in-human (FIH) device and drug-device studies often raise this question at the feasibility stage. At bioaccess®, it is an operational item handled in study execution. For each filing, we map which quality document is required. We check that the attestation or certificate covers the right sites, product and lots. We sequence it so the import step doesn’t stall the first shipment. This guide sets out what the regulations say, with the primary source next to each requirement.

Terms that get mixed up

GMP attestation, declaration or constancia

A document signed by the manufacturer, usually by its quality head or qualified person (QP), stating that the investigational product was made in compliance with GMP or under a quality management system (QMS). The regulations use different words for it: constancia (Costa Rica), declaración de buenas prácticas de fabricación de persona calificada (Panama), declaración de conformidad por parte del fabricante (El Salvador).

GMP certificate

A certificate issued by a health authority after it has verified a manufacturing site. Spanish-language rules call GMP buenas prácticas de manufactura (BPM) or buenas prácticas de fabricación (BPF).

ISO 13485 certificate

A certificate from a certification body showing that a device manufacturer’s QMS conforms to ISO 13485, the medical device QMS standard of the International Organization for Standardization (ISO). It is not the same document as a GMP certificate issued by a health authority. None of the trial-specific texts reviewed below names ISO 13485 as a mandatory document for an investigational device.

Three filing stages, three different gates

• Ethics committee (EC): reviews the study package, which can include a GMP statement.
• Regulator or Ministry of Health review: evaluates the investigational product and its quality documents.
• Import or customs release: clears each shipment, and can ask for its own quality document.

Treat each stage as a separate checklist. A document accepted at one stage doesn’t automatically satisfy the next.

Country-by-country: attestation or certificate?

Costa Rica: attestation at the EC, certificate at customs release

For studies with drugs or biomedical equipment and materials (equipo y material biomédico, EMB, Costa Rica’s legal term for medical devices), the package for the ethics committee (Comité Ético Científico, CEC) must include a constancia that the product was made under GMP. Studies with sterile devices must also include a sterility certification. The requirement does not apply if a valid GMP certificate has already been filed, or to comparators. (Decreto Ejecutivo 44033-S, amending Reglamento 39061-S, Art. 44(r).)

Import works differently. Customs release for a research product needs authorization from the Consejo Nacional de Investigación en Salud (CONIS). That filing requires a GMP certificate for each establishment involved in manufacturing, issued by the regulatory authority of the manufacturing country, as a legalized original or authenticated copy (Art. 55(g)(vi)). The same exemption applies if a valid certificate is already on file. If the manufacturing country’s authority doesn’t issue this certificate for your product, confirm the accepted alternative with CONIS for each study.

Sourced timing: the CEC decides within one calendar month of filing (Art. 42). CONIS reviews customs-release documents within five calendar days, with one ten-business-day period to correct gaps (Art. 55(h)).

Panama: certificate or qualified-person declaration

For high-risk research using “medicamentos o productos para la salud humana”, the Dirección Nacional de Farmacia y Drogas (DNFD) evaluates the product before the trial starts. The filing goes through the RESEGIS research registry (Registro y Seguimiento de la Investigación para la Salud). It requires “certificados de buenas prácticas de fabricación del medicamento en investigación o declaración de buenas prácticas de fabricación de persona calificada o equivalentes”, plus a certificate of analysis and the investigator’s brochure. Import is based on RESEGIS registration, ethics approval and DNFD authorization. (Decreto Ejecutivo 21/2026, Arts. 95 and 99.)

Article 95 is framed broadly (“products for human health”), but the document list names the investigational medicamento. For investigational devices, confirm per study which GMP or QMS document DNFD accepts.

Sourced timing: DNFD responds within 15 business days (Art. 95).

El Salvador: certificate or manufacturer declaration

The Superintendencia de Regulación Sanitaria (SRS) guide for clinical-trial authorization lists device-specific requirements. They are a GMP certificate from the manufacturer “o declaración de conformidad por parte del fabricante”; a description of the manufacturing process; a manufacturer-issued sterility certificate with the sterilization method and validation (when applicable); test results; and a risk-management plan based on ISO 14971 (SRS guide, §7.2(a)–(h)). The device technical regulation separately requires the sponsor to give the principal investigator evidence (atestados) of QMS compliance for device production (Reglamento Técnico Salvadoreño, RTS 11.03.02:21, §6.1.2(d)).

For the trial import permit, the SRS import guide lists the protocol approved by the national research ethics committee (CNEIS), the SRS favorable opinion, the current CNEIS minutes, and the inventory authorized by the SRS (§5.2.1.2). ISO 13485 appears in that guide only for other permit types, such as devices for clinical use by a health professional, where it is an alternative to authorization from the agency of origin (§5.2.1.4).

Chile: official certificate for imported pharmaceutical products

Chile’s Instituto de Salud Pública (ISP) authorizes the use of pharmaceutical products in clinical trials under Resolución Exenta 5.161. For imported products, the applicant must attach an official certificate from the competent health authority of the country where the manufacturing sites are located. The certificate must confirm that the manufacturer is authorized and complies with GMP under World Health Organization (WHO) recommendations, “u otro documento que acredite el cumplimiento de las Buenas Prácticas de Manufactura”, legalized or apostilled if applicable (Res. Exenta 5.161, Art. 2(8)).

Whether a manufacturer’s own declaration counts as “otro documento” is not defined in the text, so confirm per study. The resolution covers pharmaceutical products. Whether a given drug-device combination follows this route depends on how it is classified: confirm per study. For device-only studies, see our Chile ISP device vs drug guide.

Sourced timing: ISP rules on a customs destination certificate within three business days (Art. 17). An authorization to use a product in a trial is valid for one year and is not renewed automatically (Art. 10).

Peru: certificate or a document that guarantees compliance

For a drug investigational product, the trial authorization needs a valid GMP certificate for the manufacturer, issued by the competent authority of the country of origin, “o documento que garantice su cumplimiento” (DS 021-2017-SA, Annex 5, item 1(d)). For biological products and medical devices, the national medicines authority (Autoridad Nacional de Medicamentos, ANM) sets the required certificates or documents (Annex 5, item 3). Confirm per study.

What a defensible GMP or QMS attestation should contain

None of these countries publishes a fill-in template. The checklist below follows the elements the regulations above ask about. Its structure borrows from the European Commission’s QP declaration template, which is a model, not a Latin American requirement.

• Manufacturer letterhead, date, and the signatory’s name and role (quality head or QP)
• Product name or code, model, and the lots or serial numbers covered
• Every establishment involved in manufacturing and sterilization, with addresses. Costa Rica’s import step asks for each establishment.
• The GMP or QMS standard the manufacturer complies with
• For sterile devices, a reference to the separate sterility certificate (Costa Rica Art. 44(r); SRS guide §7.2(d))
• Language, legalization or apostille where required (Costa Rica Art. 55(g)(vi); Chile Res. 5.161 Art. 2(8))

When you need a certificate instead

• Costa Rica, customs release: GMP certificate issued by the authority of the manufacturing country (Art. 55(g)(vi)).
• Chile, imported pharmaceutical products: official authority certificate, or another document proving GMP compliance (Res. 5.161 Art. 2(8)).
• Peru, drug products: country-of-origin GMP certificate, or a document that guarantees compliance (Annex 5, 1(d)).
• Panama and El Salvador: a certificate is one of two accepted options at regulator review (DE 21 Art. 95; SRS guide §7.2(a)).

Common sponsor mistakes

• Assuming the EC-stage attestation also clears import. In Costa Rica it doesn’t (Art. 55(g)(vi)).
• Sending an ISO 13485 certificate where a health authority’s GMP certificate is requested (Costa Rica Art. 55(g)(vi); Chile Res. 5.161 Art. 2(8)).
• Leaving out the separate sterility certificate for sterile devices (Costa Rica Art. 44(r); SRS guide §7.2(d)).
• Covering only the final assembly site when the text asks for every establishment (Costa Rica Art. 55(g)(vi)).
• Skipping legalization or apostille (Costa Rica Art. 55(g)(vi); Chile Res. 5.161 Art. 2(8)).

Timing you can plan around

• Costa Rica: CEC decision within one calendar month (Art. 42). CONIS customs-release review within five calendar days, plus one ten-business-day correction period (Art. 55(h)).
• Panama: DNFD response within 15 business days (DE 21/2026 Art. 95).
• Chile: ISP customs destination certificate within three business days (Res. 5.161 Art. 17). The use authorization is valid for one year (Art. 10).

We don’t cite timelines for El Salvador or Peru because the texts reviewed here don’t set them.

Kickoff checklist for the quality package

• List every manufacturing and sterilization establishment for the investigational product.
• Decide, country by country, whether you will file an attestation, a certificate, or both.
• Prepare a sterility certificate for sterile devices.
• Plan for legalization or apostille where the text requires it.
• Line up the import-stage document before the first shipment, not after ethics approval.

Related reading: Good Laboratory Practice (GLP), GMP and sterility for early feasibility device trials · Importing investigational devices into Latin America · Investigational device import calendar · Importer of record for clinical-trial devices

FAQ

Do I need an ISO 13485 certificate to run a first-in-human device trial in Costa Rica, Panama, El Salvador or Chile?

None of the trial-specific texts reviewed names ISO 13485 as mandatory. Costa Rica asks for a GMP statement at the ethics committee and an authority-issued GMP certificate at customs release. El Salvador accepts a GMP certificate or a manufacturer declaration of conformity. Panama’s device requirements and Chile’s device-only requirements should be confirmed per study.

Is a qualified-person GMP declaration accepted in Panama?

Yes. Decreto Ejecutivo 21 of 2026, Article 95, accepts GMP certificates or a qualified-person GMP declaration or equivalents for the investigational medicinal product. For devices, confirm the accepted document with the Dirección Nacional de Farmacia y Drogas per study.

Does Costa Rica accept a manufacturer attestation?

At the ethics committee, yes: Article 44(r) of the amended Reglamento 39061-S asks for a statement that the product was made under GMP, plus sterility certification for sterile devices. For customs release, Article 55(g)(vi) asks for a GMP certificate issued by the authority of the manufacturing country.

What does Chile’s ISP accept for imported pharmaceutical products?

Resolución Exenta 5.161 asks for an official certificate from the health authority of the manufacturing country confirming authorization and GMP compliance, or another document that proves GMP compliance, legalized or apostilled if applicable.