Panama’s Five-Layer Legal Framework for Medical Devices

1. Key takeaways

The Panamanian legal framework for medical devices is built from the bottom up in five layers: the Constitution, the statute (Ley), the executive decree (Decreto Ejecutivo), the ministerial resolution (Resolución), and finally notices and forms (Comunicado, Formulario). Two instruments carry the weight in the device field: Ley N° 90 of 26 December 2017, with 52 articles, and Decreto Ejecutivo N° 490 of 4 October 2019, with 74 articles. Every compliance judgement should be traceable back to a specific provision at one of those layers. Judgements that rest on industry practice alone are not reliable in Panama.

• Article 109 of the Constitution is the authorising source for the whole chain, not a preamble ornament.
• Ley 90 authorises; DE 490 and the later resolutions operationalise. Neither works on its own.
• DE 490 has been amended more than once, so the 2019 text cannot be read as current law.
• Ministerial resolutions add requirements category by category, so no category can be assumed to follow the general rule.

2. Legal basis

The five layers and the instruments that occupy them are set out below. Dates and gazette references matter here, because several instruments take effect on the day after publication while others take effect on the day of publication, and the difference decides which version governs a file already in process.

The FUNDAMENTO DE DERECHO of DE 490, in the official wording, cites the Constitution; Ley 66 of 10 November 1947 (the Health Code of the Republic of Panama); Ley 90 of 2017; Ley 92 of 2019; and Decreto de Gabinete No. 1 of 15 January 1969.

3. Expert insights

Insight one: Article 109 of the Constitution is the authorising source for every device regulation. The first recital of both DE 490 and Decreto Ejecutivo No. 1689 begins from Article 109 and works the duty to safeguard health down through the layers to the specific rule. The practical meaning of that chain is that Panamanian device regulation carries a strong public health discretion. The DNDM can take temporary measures on public health grounds under Article 41 of Ley 90, and the room for an applicant to argue that a regulation does not expressly prohibit something is correspondingly narrow. Compliance arguments built on silence in the text tend to lose.

Insight two: the division of labour between statute and decree is authorisation against implementation. Ley 90 supplies the framework and the powers; almost every workable requirement sits in DE 490 and the resolutions that follow it. The decree specifies 13 general items of documentation (Article 36), special requirements that escalate with risk (Article 37), 17 items for instructions for use (Article 38), 12 items for labelling (Article 40), official fees (Article 64) and 13 grounds for cancellation (Article 67). Reading only the statute leaves you unable to assemble a dossier. Reading only the decree leaves you unaware of the boundary of the authorisation. The two have to be used as a pair, provision by provision.

Insight three: DE 490 has been amended at least twice, and reading the 2019 original produces errors. Decreto Ejecutivo N.º 416 of 13 May 2020 amended Articles 17 and 36 and added Article 36-A. Decreto Ejecutivo No. 1689 of 29 December 2020 amended Article 35-A, which had itself been added by Decreto Ejecutivo No. 849 of 2 July 2020. The change with the greatest practical reach is in item 10 of Article 36: what was a good manufacturing practice certificate or other quality certification is now a valid ISO 13485 certificate. Any reference to Article 36 must state that it is amended by DE 416, otherwise the citation describes law that no longer exists.

Insight four: ministerial resolutions are how Panama moves from a general rule to a specific product category. Resolución N° 003 of 2024 governs condoms specifically; Resolución N° 694 of 2023 approves the classification of dressings containing an active ingredient; Resolución N° 120 and N° 122 of 2022 classify particular products as medicines. Category regulation in Panama is therefore cumulative and layered. A company cannot assume that the requirements for one category apply to another, or that the general rule in DE 490 is the last word on a product that has attracted its own resolution.

4. Practical recommendations

• Build a two-source index in which each compliance requirement records both the statutory provision and the decree or resolution provision, so that a single repealed clause does not silently remove the requirement from your tracker.
• Annotate every citation of DE 490 with its amendment status, in particular Articles 17, 35-A, 36 and 36-A, and date the annotation.
• Search for a category-specific resolution before relying on the general rule, and record the search result even when nothing is found.
• Include Article 109 of the Constitution and the DNDM power to take temporary measures under Article 41 of Ley 90 in the risk assessment, and keep a response procedure for seizure or suspension in the contingency plan.
• Review the legal-source list on the DNDM page of the MINSA website each quarter and confirm whether any instrument has been added or repealed since the last review.

5. Verification checklist

• □ Record Article 109 of the Constitution as the top-level authorisation
• □ Record the commencement rules for Ley 90 (52 articles) and Ley 92 (Article 52 of Ley 90)
• □ Record DE 490 (74 articles) and Article 74: in force from the date of publication
• □ Record the amendments made to DE 490 by DE 416 and DE 1689
• □ List the ministerial resolutions and notices that apply to the product in question
• □ Confirm the review date and the responsible person for the legal-source list

Regulatory information verified to 29 October 2026.

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 registrations through the DIGEMID-equivalent medical device directorate, prepares Spanish-language dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com