Five Operating Licence Categories in Panama: Fábrica, Acondicionadora, Distribuidora, Minorista and Almacén

1. Key takeaways

Article 14 of Decreto Ejecutivo N° 490 splits the medical device operating licence (Licencia de Operación, LO) into five categories, and the category a company selects defines the entire perimeter of what it may lawfully do in Panama. They are not interchangeable labels on the same permission but a ladder of descending authority, from a manufacturer that may carry out every commercial function to a warehouse that may only store product. The licence is an establishment-level credential: it certifies that a site and its processes meet the quality and safety standards required for the activity declared, and it names the legal person and representative behind the operation.

• Fábrica (manufacturer) — authorises manufacture, conditioning, export, import, distribution, sale and storage of devices, the broadest package in the article.
• Acondicionadora (conditioner) — authorises conditioning, export, import, distribution, sale and storage, but not manufacture.
• Distribuidora (distributor) — authorises export, import, distribution, sale and storage, the category most foreign suppliers actually need.
• Minorista (retailer) — authorises sale and storage only, with no import or distribution rights attached.
• Almacén (warehouse) — authorises storage only, a single function and nothing beyond it.
• Two delegated lists — exempt establishment types and the list of freely sold devices are set by DNDM resolution rather than by the decree itself, so they must be searched separately.
• No pharmaceutical use — the licence guarantees the sale of devices and related products only and may not be used for the sale of medicines.

2. Legal basis

The classification comes from Article 14 of Decreto Ejecutivo N° 490 of 4 October 2019, published in Gaceta Oficial 28875-A. Article 12 of the same decree contains the underlying obligation to hold a licence and the restriction on pharmaceutical use, while Article 24 of Ley N° 90 of 26 December 2017 (Gaceta 28433-B) states the same rule at the level of statute and leaves the detail to the regulations of the Dirección Nacional de Dispositivos Médicos (DNDM). Resolución N° 003 of 15 February 2024 supplies the first worked example of the delegated exemption, carving out retail premises that sell only freely sold devices and requiring mixed retail operations to apply.

3. Expert insights

Insight one: the five categories form a structure of descending authority, and choosing the wrong rung directly restricts the business model. The ladder runs from the seven functions of Fábrica down to the single function of Almacén, and each step removes something concrete rather than merely relabelling the holder. The most common mistake we see is a company that intends to import and distribute but files as Minorista, because retail sounds like the natural entry point for a local subsidiary. The result is a licence that authorises sale and storage only, with import activity outside the authorised scope. Article 12 requires the applicant to set out the requested type in the form itself (indicar en el formulario el tipo de solicitud que requiere), which makes the category choice explicit rather than implicit and removes any later argument that the scope was unclear.

Insight two: the bar on pharmaceutical sales is a restriction with penalty consequences attached. The second paragraph of Article 12 and Article 24 of Ley 90 both state that the licence may not be used for the sale of medicines. This is not an advisory note. Article 69, item 3, of DE 490 lists as a ground for suspension of the operating licence the conduct of commercial activity with devices and related products outside the authorised scope without reporting it to DNDM. Cross-category trading that is not reported carries a suspension, and a second occurrence leads to cancellation. A distributor that quietly adds a line of products requiring a different permission is therefore exposing the entire licence, and with it every product sold under that licence.

Insight three: the final paragraph of Article 14 hands two exemptions to DNDM by resolution. One is the category of establishments that do not need an operating licence; the other is the list of freely sold devices that may be marketed. Neither is enumerated in the law, so both have to be located in DNDM resolutions rather than inferred from the decree. Article Cuarto of Resolución N° 003 de 2024, which exempts retail outlets selling only over-the-counter devices, is the working example of the second delegation and shows how narrow such carve-outs can be drawn.

Insight four: the conditioning category is a business form particular to Panama. Definition item 4 describes acondicionamiento as any activity carried out or authorised by the manufacturer the result of which is that the device is considered finished and ready for sale and use. The Acondicionadora licence exists precisely for that final processing and packaging step, which in many other jurisdictions is absorbed into manufacturing or treated as a low-risk activity requiring no establishment permission at all. The second paragraph of Article 18 adds a documentary condition: premises applying under the conditioning category must submit the manufacturer authorisation for the devices being conditioned. Without that authorisation in the file, the application is incomplete regardless of how well the site itself is equipped.

4. Practical recommendations

• Choose the licence category by working backwards from the full chain of activities the entity will perform, and err on the higher rung rather than the lower one; any import operation requires Distribuidora at a minimum.
• State the requested application type explicitly in the form at the time of filing, so that a scope shortfall is identified during intake rather than after the licence is issued.
• Keep the device licence entirely separate from any pharmaceutical activity, including ancillary or occasional sales, since the restriction is absolute in the text.
• Complete a licence update (actualización) before extending the product range or the activity set, rather than trading first and regularising afterwards.
• For conditioning operations, obtain the manufacturer authorisation for the affected devices before filing, as required by the second paragraph of Article 18.
• Search the current DNDM resolutions on exempt establishment types and the freely sold device list before assuming that a licence is or is not required for a given site.

5. Verification checklist

• □ Licence category selected against the actual activity set (Article 14, items 1 to 5)
• □ Import, distribution, manufacture and storage all confirmed to sit inside the authorised scope
• □ Licence confirmed not to be used for any pharmaceutical sale (Article 12, second paragraph)
• □ DNDM resolutions on exempt premises and the over-the-counter list searched and on file
• □ Manufacturer authorisation obtained for any conditioning activity (Article 18, second paragraph)
• □ Licence update completed before any extension of the business scope
• □ Application type stated in the form and matched to the category requested

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