Panama Risk Classification A/B/C/D under DE 490 Article 30

1. Key takeaways

Panama classifies medical devices into four classes by risk: class A (low risk), class B (low to moderate risk), class C (moderate to high risk) and class D (high risk). The legal basis is Article 30 of Decreto Ejecutivo N° 490, not Article 15, which deals with the prohibition on operating a device business inside a dwelling. The classification rules must apply the most current version of the GHTF and IMDRF risk classification (Grupo de Trabajo de Armonización Global / International Medical Device Regulators Forum) or the documents of a successor body, and the DNDM is the authority for risk classification, with binding decisions (Article 16 of Ley 90). The claim circulating in Chinese-language material that Panama uses classes I, II and III is wrong.

• Four classes, lettered A to D, defined in Article 30 of DE 490.
• The classification rules are a living reference to the current GHTF and IMDRF version, not a frozen annex.
• The manufacturer’s own declaration is the starting point of the class, which places responsibility on the applicant.
• Class drives document volume, review format and the phase-in deadline, so it is the highest-leverage decision in a project.

2. Legal basis

Article 30 of DE 490 defines the classes and the rules for choosing between them; Article 16 of Ley 90 fixes the authority; Articles 31, 33 and 37 then attach consequences to the class. The consequences are what make the classification decision commercially significant rather than a labelling exercise.

3. Expert insights

Insight one: the reference to the most current GHTF and IMDRF version is a living clause. Article 30 of DE 490 and Article 16 of Ley 90 both use the phrase most current version. The direct consequence is that Panamanian classification rules move when the IMDRF documents move, without any amendment to DE 490 itself. A class that was assigned in another country under an older rule set may therefore not hold in Panama. At the classification stage, state the version of the IMDRF document relied on, rather than writing that the product was classified according to GHTF rules in general terms.

Insight two: classification follows the manufacturer’s declaration, which puts the first responsibility on the company. The opening sentence of Article 30 ties the class to the risk associated with use and to the vulnerability of the human body, and to what the manufacturer declares. Combined with Article 33, under which all information submitted rests on a sworn declaration, the company carries responsibility for the truth of the class it declares. A false declaration leads directly to the cancellation grounds in Article 67 of DE 490 and to the very serious infringement in Article 37 of Ley 90. Classification is a legal liability point, not a technical formality.

Insight three: because the DNDM decision is binding, the dispute route is constrained. The closing sentence of Article 16 of Ley 90 makes the DNDM the authority for risk classification and makes its decisions binding. A company that disagrees with a class cannot fall back on industry practice; the argument has to be made inside the DNDM process. The more effective course is to make the classification argument solid before submission rather than to contest it afterwards, because a contested file has already lost the review time that a well-argued one keeps.

Insight four: the class setting moves three cost lines at once. The first is document volume, since Article 37 adds special requirements step by step from A to D. The second is the review format, since Article 31 requires at least two specialist physicians for classes C and D while leaving that optional for A and B, which changes review duration. The third is the transitional period, since Article 23 of Ley 90 sets 18, 24, 30 and 42 months for classes D, C, B and A respectively. Of all the decisions in a Panamanian project, the class has the highest leverage.

4. Practical recommendations

• In the classification rationale, name the GHTF or IMDRF document version and the specific rule numbers applied. Do not accept a formulation that rests on customary practice.
• Where two classes are plausible, prepare the file for the higher class immediately rather than submitting at the lower class and being asked to supplement.
• For class C and D projects, reserve time in the schedule for the specialist assessment and do not count it as running in parallel with document preparation.
• Keep the class consistent across the intended use, the label and the instructions for use; drift in any one of the three invites a fresh classification.
• Treat a change of class as a substantial change and discharge the notification duty under Article 43 of DE 490.

5. Verification checklist

• □ Confirm the classification provision is Article 30 of DE 490, not Article 15
• □ Confirm the four classes are A (low), B (low to moderate), C (moderate to high) and D (high)
• □ Record the version of the GHTF or IMDRF document relied on
• □ Check whether the product can fall into two classes at once (Article 30, third paragraph)
• □ Confirm whether class C or D triggers the specialist assessment (Article 31)
• □ Check the special requirements for the class against Article 37

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