Twelve Information Items on Import Invoices under Article 27 of Ley 90

1. Key takeaways

Article 27 of Ley N° 90 requires twelve items of information whenever devices and related products enter or leave Panama, and requires that information to be verified on the invoice and other documents connected with the import and export process. The obligation therefore attaches to commercial paperwork rather than to a separate declaration form. Item eleven, a copy of the Panamanian sanitary registration save for the exceptions established by the law and its regulations, is the point where the requirement meets the current registration position, and it is the item that most often needs to be resolved case by case.

• 1. Name of the manufacturer.
• 2. Name and address of the importer or exporter, as applicable.
• 3. Invoice number.
• 4. Commercial name of the product.
• 5. Catalogue number of the product, where applicable.
• 6. Description of the packaging specification.
• 7. Model and serial number of biomedical equipment.
• 8. Lot number of the product, where applicable.
• 9. Quantity by lot, where applicable.
• 10. Expiry date of the product, where applicable.
• 11. Copy of the Panamanian sanitary registration, except for the exceptions established in the law and its regulations.
• 12. Any other information required by the health authority.

2. Legal basis

Article 27 of Ley N° 90 of 26 December 2017 (Gaceta 28433-B) contains both the list and the verification rule. Article 21 sets out the five exceptions under which goods may be imported without registration, and Article 28 grants the duty exemption. Definitions 69 and 74 of Article 2 of DE 490 supply the meaning of lot and serial number, which determines how items 7 and 8 are completed.

3. Expert insights

Insight one: the operative question in Article 27 is not what must be present but where it must be verified. The second paragraph names the invoice and other documents related to the import and export process as the verification medium. The twelve items are therefore not fields on a standalone declaration but mandatory content of the commercial documents. The practical consequence is that the invoice template has to be redesigned, because an explanatory note attached at the time of customs clearance does not satisfy a rule addressed to the invoice itself. Exporters who treat the requirement as a customs formality discover the problem when the broker rejects the document set rather than when the goods arrive.

Insight two: item 7 confines model and serial number to biomedical equipment, and that is a consequence of classification. The official wording is Modelo y número de serie de equipo biomédico, so the serial number is demanded only for equipment. This matches definition 74 of DE 490, under which the serial number is the identifier the manufacturer assigns to biomedical equipment. Consumables and general devices are covered by the lot number in item 8 instead. Mixing the two, for example by demanding serial numbers for consumables or by supplying only a lot number for an equipment line, produces a mismatch that is visible on the face of the invoice.

Insight three: item 11 requires a copy of the Panamanian sanitary registration, and there is tension between that requirement and the moratorium. The official wording is Copia del Registro Sanitario de Panamá, salvo las excepciones establecidas en esta Ley y su reglamentación. At a time when sanitary registrations are not being issued as a matter of routine, how the item is satisfied is a practical question: it may be met by a CCT, a Certificado de Inscripción or an authorisation under the exceptions in Article 21 (practical estimate, subject to the current position of customs and DNDM). What the item does not permit is leaving the field blank on the assumption that no credential exists to cite.

Insight four: Articles 27 and 28 have to be read as a pair, complete information in exchange for duty-free entry. Article 27 demands twelve items in full, and Article 28 removes import duty. The two provisions run in opposite directions and the institutional logic is an exchange: information completeness buys clearance efficiency. A supplier enjoying the zero-duty treatment cannot justify a simplified document set on the ground that the goods are duty free, because the exemption removes the fiscal charge and not the documentary condition attached to it.

4. Practical recommendations

• Rebuild the export invoice template around the twelve items and manage it separately from templates used for other destinations.
• Distinguish the serial number requirement for equipment from the lot number requirement for consumables and general devices.
• Reserve a field on the invoice for the Panamanian registration number and complete it according to the credential actually available at the time.
• Where import without registration is claimed under Article 21, cite the exception relied on in the accompanying documents.
• Confirm the verification practice with the customs broker and add the twelve items to the pre-clearance self-check.
• Brief suppliers on the invoice layout, since the fields must be produced at origin rather than added after shipment.

5. Verification checklist

• □ Invoice template contains all twelve fields
• □ Equipment lines carry model and serial number; consumable lines carry lot number
• □ Quantity by lot and expiry date completed where applicable
• □ Panamanian registration field completed with the credential in force
• □ Exception relied on recorded where import without registration is claimed (Article 21)
• □ Twelve-item self-check completed before customs clearance

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