OTC Medical Devices in Panama and the Operating Licence Exemption

1. Key takeaways

Panamanian law recognises a category of device for free sale (dispositivo médico de venta libre, OTC), meaning self-care hygiene products such as adhesive bandages, support stockings and thermometers (definition 27 of Article 2 of DE 490). The category has three consequences. First, the DNDM is to publish by resolution a list of premises that do not require an operating licence and a list of OTC devices that may be sold (Article 14, final paragraph of DE 490). Second, a retail premises that sells only OTC devices is exempt from applying for a device operating licence, while one that also sells other devices must apply (Resolución N° 003 of 2024, Articles Cuarto and Quinto). Third, condoms are expressly treated as OTC devices (Article Tercero of the same resolution).

• The exemption is a premises licence exemption, not a product obligation exemption.
• It survives only while the range is exclusively OTC; mixing in one other device ends it.
• The OTC list is published by resolution and changes, so the definition examples are not the list.
• The location rules in Article 15 apply whether or not a licence is required.

2. Legal basis

The statutory licence duty sits in Article 24 of Ley 90; the OTC carve-out is built from Article 14 of DE 490 and completed by Resolución N° 003 of 2024. The resolution is short but its articles are numbered in words, and each one answers a different question: what counts as OTC, who is exempt, who is not, and what the product itself still needs.

3. Expert insights

Insight one: OTC status removes the premises licence, not the product obligation. This is the point most often confused. Article Cuarto of Resolución N° 003 exempts the retail premises from applying for an operating licence (Licencia de Operación), which is a concession to the operator. The product itself still has to be registered: Article Séptimo of the same resolution requires anyone importing condoms into Panama to register (inscribir) the product with the DNDM. Reading the licence exemption as a product exemption is the most common compliance accident in the OTC category, and it usually comes to light at customs rather than at the shop.

Insight two: the exemption belongs to the purely OTC shop and lapses on mixing. Articles Cuarto and Quinto form a pair: premises selling only OTC are exempt, premises selling OTC alongside other devices must apply. The test is whether the product range is single, not the size of the shop or its turnover. The moment a retail outlet adds one non-OTC device, the exemption ends and a licence application becomes due immediately. Operating past that point falls within item 6 of Article 36 of Ley 90, which treats operating without a licence as a serious infringement.

Insight three: the OTC list is a dynamic list published by resolution, not a statutory enumeration. The final paragraph of Article 14 of DE 490 gives the DNDM the power to set the list and requires publication by resolution. Definition 27 offers examples only, adhesive bandages, compression stockings and thermometers, and those examples do not constitute an exhaustive list. The scope of OTC therefore moves with each resolution, and a company cannot conclude that its product is OTC simply because it resembles one of the examples in the definition.

Insight four: the location prohibition in Article 15 is independent of the licensing regime. Article 15 of DE 490 prohibits the sale of devices inside inhabited dwellings and restricts premises in PH (Propiedad Horizontal) buildings to areas reserved for commercial use. That restriction does not fall away because a product is OTC or because an exemption applies. The pattern common among cross-border sellers and small distributors, a residential stockroom that doubles as a sales point, breaches Article 15 directly, and the breach cannot be cured by a later application because the location itself is the problem.

4. Practical recommendations

• Determine OTC status from the resolution list the DNDM has published at the time, not from the examples in definition 27 of DE 490.
• Before a retail outlet adds any non-OTC device to its range, complete the licence application first, so that there is no gap in which the shop trades without cover.
• Manage the product registration duty as a separate timeline from the premises licence, since OTC products still have to be inscribed with the DNDM.
• Rule out residential premises and non-commercial areas of PH buildings at the site selection stage, because a wrong location cannot be remedied by a subsequent application (Article 15).
• Keep a table mapping the shop’s product range against the scope of its operating licence, and re-check it at every range change.

5. Verification checklist

• □ Confirm whether the product appears on the OTC list published by the DNDM (Article 14, final paragraph)
• □ Confirm whether the retail premises sells OTC only, which decides the exemption
• □ Confirm whether the product registration has been completed (Article Séptimo of Resolución 003)
• □ Confirm the premises are not in a dwelling or a non-commercial area of a PH building (Article 15)
• □ Re-check the licence scope after any change to the product range
• □ Record the publication date and the review date of the OTC list resolution

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