Who Regulates Medical Devices in Panama: MINSA, DNDM and DNFD

1. Key takeaways

Medical devices in Panama are regulated, and their rules are made, by the Ministry of Health (Ministerio de Salud, MINSA). The directorate that carries out that work inside MINSA is the National Directorate of Medical Devices (Dirección Nacional de Dispositivos Médicos, DNDM). The National Directorate of Pharmacy and Drugs (Dirección Nacional de Farmacia y Drogas, DNFD) does not deal with devices. It is consulted by the DNDM in two situations only: products or technologies that are difficult to separate into devices, medicines or another category (Article 11 of Ley 90), and procedure packs that combine a medicine with a device (Article 20 of Ley 90). Filing a device registration with the DNFD is the most frequent and the most costly error in Chinese-language material on this market.

• MINSA is the regulating authority and the rule-maker; the DNDM is the directorate that executes.
• The DNFD appears only as a consulting party, on borderline classification and on medicine-device packs. Neither provision moves the competence.
• The DNDM is not a new institution. It is the former medical technology surveillance department, reorganised as a directorate.
• Free zones and processing zones are not outside the reach of the health authority, whether on public health grounds or at the request of a manufacturer or distributor.

2. Legal basis

Competence is fixed at two levels. Ley 90 creates the directorate and gives it its mandate; Decreto Ejecutivo 490 confirms it as the national authority for regulation, management and vigilance of devices and lists its operational functions. The table below sets out the provisions that matter when a company is deciding where to file and who signs.

Organisational basis: Resolución No. 372 of 7 May 2019 (the new MINSA organisational structure and organisation manual, which places the DNDM at operational level). That number is cited in the CONSIDERANDO section of Resolución N° 003 of 15 February 2024.

3. Expert insights

Insight one: the DNDM is a reorganisation rather than a new institution, and that single fact defines its capability boundary. Article 4 of Ley 90 states that the DNDM takes over the former Department of Regulation and Surveillance of Medical Technologies as a whole. The technical DNA of the directorate therefore comes from surveillance and vigilance of medical technology, not from pharmaceutical review. When a device dossier is filed in Panama, the review logic is closer to a technical specification check against the CTNI Ficha Técnica than to a pharmaceutical assessment of safety, efficacy and stability. Teams that carry habits from a medicine registration into a Panamanian device file are misaligned from the first page.

Insight two: two of the twelve functions drive the project schedule more than any other provision. Article 7, item 1 of Ley 90 empowers the DNDM to define the minimum requirements, procedures and deadlines for obtaining a device sanitary registration. Item 4 empowers it to define the requirements, procedures and deadlines for the technical verification certificate (CVT). Panama therefore does not exhaust its registration requirements in the statute. The DNDM keeps defining them through regulations and resolutions, and the definitions move. A project that is prepared only against the articles of the law, without re-checking the forms and manuals the DNDM publishes at the time of filing, will be returned at the formal examination stage before any technical question is reached.

Insight three: the second paragraph of Article 3 of DE 490 reaches into the free zones. Under that paragraph, inside free zones, processing zones or similar special fiscal or customs territories, the health authority may intervene on public health grounds or at the request of a manufacturer or distributor. Panama uses the Colón Free Zone as a regional distribution hub, and warehousing and re-export operations inside the zone are not outside the law. This is consistent with Article 1 of Ley 90, which brings special territories within the scope of application. Together the two provisions produce a feature that distinguishes Panama from much of Central America: a customs enclave is not a regulatory enclave.

Insight four: the role of the DNFD is that of a consulted party, never of the competent authority. Article 11 of Ley 90 is triggered when a product or technology appears that is difficult to classify as a device, a medicine or something else, and only where no high-standard health authority recognised by the World Health Organization has already classified it; in that case the DNDM and the DNFD classify jointly and issue the corresponding regulation. Article 20 addresses procedure packs containing a medicine and a device and requires the two directorates to design the procedure jointly. Both are consultation clauses. Neither transfers the addressee of the device file, and neither gives the DNFD a veto over an ordinary device submission.

4. Practical recommendations

• At project initiation, lock every official contact, submission and enquiry channel to the DNDM, using the contacts published on the DNDM page of the MINSA website. Do not route device material through a medicines channel.
• State the classification conclusion and its legal basis on the first page of the dossier, citing definition 14 of Article 6 of Ley 90. This prevents the intake desk from treating the file as a borderline product and transferring it for joint review.
• For medicine-device combinations and borderline items such as dressings containing an active ingredient, search the joint classification resolutions of the DNDM and the DNFD in advance (for example Resolución N° 120 of 2022, N° 122 of 2022 and Resolución N° 694 of 2023) and adopt the existing conclusion rather than arguing the question again.
• If you warehouse in a Panamanian free zone or processing zone, confirm whether the operation triggers intervention by the health authority, and write that compliance judgement into the warehousing agreement.
• Build a legal-source review gate into the workflow: before every submission, check the version numbers of the DNDM forms, manuals and resolutions then in force, and never reuse an earlier version.

5. Verification checklist

• □ Confirm the competent authority is MINSA and the executing body is the DNDM (Articles 2 and 3 of Ley 90)
• □ Confirm the DNDM was created by reorganising the former Department of Regulation and Surveillance of Medical Technologies (Article 4 of Ley 90)
• □ Record the 12 functions of the DNDM under Article 7 of Ley 90 and the 7 functions under Article 4 of DE 490
• □ Confirm the DNFD participates only in the scenarios of Articles 11 and 20 of Ley 90
• □ Confirm whether the commercial or warehousing operation touches a free zone or processing zone (Article 3 of DE 490)
• □ Check whether Resolución No. 372 of 2019 remains the current organisational basis

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