Three Infringement Tiers and Fine Bands under Ley 90

1. Key takeaways

Articles 35 to 37 of Ley N° 90 sort infringements into three tiers: minor (leves), serious (graves) and very serious (gravísimas). Article 44 attaches the fine ranges: minor B/.500.00 to B/.5,000.00, serious B/.5,001.00 to B/.50,000.00, and very serious from B/.50,001.00 upwards. The first item in the very serious tier is selling devices without sanitary registration, save for the exceptions the law authorises. In addition, Article 34 separately prohibits the repackaging, relabelling and reconditioning of devices.

• Three tiers, three fine bands — the bands are contiguous, so the tier into which conduct falls determines the exposure before any mitigating factor is considered.
• Unregistered sale leads the top tier — the most severe classification is reserved for placing devices on the market without the product credential.
• Six sanctions, not one — Article 39 permits a warning, suspension or cancellation of credentials, temporary closure and a fine, and they may be applied together.
• Vigilance failure is punishable — concealing or failing to report alerts, recalls and adverse events is itself an infringement under Article 35.
• Scope breaches are serious — trading without a licence, or outside the authorised scope, sits in the serious tier under Article 36.
• Repackaging is prohibited outright — Article 34 is a standalone prohibition, not a labelling rule to be managed by procedure.

2. Legal basis

Ley N° 90 of 26 December 2017 (Gaceta 28433-B) contains the whole penalty framework. Article 34 states the prohibition on repackaging, Articles 35 to 37 define the three tiers, Article 39 lists the sanctions, Article 40 the factors that determine their measure, Article 41 the precautionary measures, Article 42 the appeal route and Article 44 the fine bands.

3. Expert insights

Insight one: the clash between Article 37, item 1, and the moratorium is the largest grey area in Panamanian compliance. The first very serious infringement is selling products without sanitary registration, save for the exceptions the law authorises, yet sanitary registrations are not being issued as a matter of routine (Article 18 of Ley 92). How the provision is currently applied must be read from the position of DNDM and customs at the time (practical estimate). For a company the practical conclusion is that credential status has to be documented: holding written proof of a CCT, an inscription certificate or an exception authorisation is the basic defence against an allegation under this item, and an undocumented assumption that the credential was not needed is not a defence at all.

Insight two: Article 35, item 2, makes late vigilance reporting a punishable infringement, a comparatively strict position for Central America. The article penalises deliberately concealing or failing to report alerts, voluntary recalls, adverse events and potential adverse events. Combined with the seventy-two hour emergency reporting duty in Article 56 of DE 490, vigilance in Panama is a hard obligation supported by a penalty rather than an aspiration expressed in guidance. The word deliberately narrows the mental element for concealment, but failure to report in time does not depend on intent, so the exposure arises from process failure as much as from misconduct.

Insight three: Article 36, item 6, classifies both unlicensed operation and out-of-scope operation as serious. The item catches operating premises without the corresponding licence and engaging in unauthorised commercial activity with devices. This corresponds to Article 69, item 3, of DE 490, which makes trading outside the authorised scope without reporting it to DNDM a ground for suspension. The two provisions reinforce each other: extending a product range without updating the licence is not an administrative oversight to be regularised later but a serious infringement in its own right, carrying consequences on both the penalty and the licence side.

Insight four: Article 39 offers six sanctions that may be imposed together, and the fine is only one of them. The official text reads serán objeto de una o más de las sanciones siguientes, one or more of the following sanctions. Suspension or cancellation of the operating licence under item 4, and temporary closure of premises under item 5, are far more damaging than a fine, particularly when read with the knock-on consequence in Article 69 of DE 490, under which loss of the licence removes the marketing qualification of every product held by the entity. Assessing penalty risk by reference to the fine band alone therefore understates the exposure by a wide margin.

4. Practical recommendations

• Document credential status throughout, whether CCT, inscription certificate or exception authorisation, as the basis for answering an allegation under Article 37, item 1.
• Establish a separate vigilance reporting process with time controls no weaker than the seventy-two hour standard in Article 56 of DE 490.
• Complete the licence update before extending the product range, rather than trading first and regularising afterwards.
• When assessing penalty risk, evaluate the knock-on effect of suspension or cancellation of the licence ahead of the fine amount.
• On receipt of a penalty decision, file reconsideration and appeal within the statutory period under Article 42, noting that both are granted with devolutive effect.
• Review labelling and expiry controls against Article 36, items 3 and 4, since these are the serious infringements most often generated by warehouse practice.

5. Verification checklist

• □ Three prohibitions under Article 34 recorded (repackaging, relabelling, reconditioning)
• □ Two minor infringements under Article 35 reviewed
• □ Six serious infringements under Article 36 reviewed
• □ Four very serious infringements under Article 37 reviewed
• □ Three fine bands under Article 44 recorded
• □ Appeal route confirmed (Article 42, reconsideration and appeal)
• □ Precautionary measure exposure under Article 41 understood

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 registration applications, prepares Spanish-language dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com