Borderline Products in Panama: Ley 90 Article 11 and DNFD Classification

1. Key takeaways

When a product or technology appears that is difficult to classify as a device, a medicine or something else, Panama has the DNDM and the DNFD classify it jointly and issue the corresponding regulation, under Article 11 of Ley N° 90. The article carries a precondition: it applies only where no high-standard health authority recognised by the World Health Organization has already classified the product. In other words, if a WHO-recognised high-standard authority has already taken a position, Panama follows the existing classification and does not open the joint procedure. The mechanism has produced concrete instruments, including Resolución N° 120 and N° 122 of 2022, which classify particular products as medicines, and Resolución N° 694 of 2023, which approves the classification of dressings containing an active ingredient.

• Joint classification is a fallback, not the default route for a difficult product.
• The precondition puts international classification ahead of domestic discretion.
• The output of joint classification is a case-specific resolution covering a named list, not a general rule.
• The exclusions in Article 1 are hard boundaries and are not reached through this mechanism at all.

2. Legal basis

Article 11 sets the mechanism and its precondition; Article 20 covers the neighbouring case of packs that combine a medicine with a device; Article 1 fixes what falls outside the law altogether. The resolutions listed are the recorded outputs, and each one binds a defined list rather than a product type.

3. Expert insights

Insight one: the precondition of Article 11 places international standards ahead of domestic discretion. The official wording limits the mechanism to cases in which no high-standard health authority recognised by the World Health Organization has classified the product. The design avoids a second round of discretionary judgement on products where an international consensus already exists. The practical consequence is direct: the classification argument for a borderline product should start from existing classifications by WHO-recognised authorities and use them as the primary evidence. Only where no such classification exists does it make sense to ask the two Panamanian directorates to classify the product themselves.

Insight two: the product of joint classification is a case-specific resolution, not a general rule. Resolución N° 120 and N° 122 each deal with a single list, namely the products in the annexes to Resolución 766 and 767, and move that list into the medicines side. The effect of such a resolution is concrete and directed. A company assessing its own product has to search the resolutions one by one to see whether any covers it, and cannot infer either that all products of the same type have been moved to medicines or that none have. Inference in either direction is the most common source of error in this area.

Insight three: the treatment of medicated dressings shows a third possible outcome. Resolución N° 694 of 6 September 2023 approves the classification of the dressings containing an active ingredient described in Annex N° 1. The existence of that instrument shows that a borderline product is not necessarily pushed to the medicines side; it can remain on the device side with its classification settled. Medicated dressings are the standard example, since they contain an active ingredient yet continue to be regulated as devices. A company should therefore not use the presence of a medicine as the dividing line, because the presence of an active ingredient does not by itself decide the question.

Insight four: the exclusion list in Article 1 is a hard boundary untouched by the joint mechanism. The final paragraph of Article 1 excludes medicines, active substances and excipients, pharmaceutical raw materials, radiopharmaceuticals and contrast media, because those are governed by other laws. These categories are not difficult to classify; they are settled as outside the device framework, and Article 11 does not apply to them. Confusing the two situations leads a file down the wrong route from the first day, and the error is usually only discovered after the dossier has been assembled and translated.

4. Practical recommendations

• Before classifying a borderline product, search international sources for a classification by a WHO-recognised high-standard authority, and present the result as the primary argument.
• Search the joint classification resolutions of the DNDM and the DNFD one by one (Resolución 120, 122, 694 and others) to see whether any already covers the product.
• For products containing a medicine or biological material, apply the combination device definition in definition 15 of Ley 90 and test whether the principal function is the device function.
• Confirm whether the product falls inside the exclusion list in Article 1 of Ley 90, and keep excluded products off the device route entirely.
• Put the classification conclusion and its basis on the first page of the dossier, and review it whenever the legal sources are updated.

5. Verification checklist

• □ Confirm whether the product falls in the exclusion list of Article 1 of Ley 90
• □ Search for an existing classification by a WHO-recognised authority (precondition of Article 11)
• □ Search the existing joint classification resolutions of the DNDM and the DNFD for coverage of the product
• □ For a medicated product, test combination device status under definition 15
• □ Record the classification conclusion and the provisions relied on
• □ Set a review point for legal updates

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