Five registration-exempt import cases under Article 21 of Ley 90, including 90-day trade fairs

1. Key takeaways

Panama allows devices and related products to be imported without a device sanitary registration in five cases, under Article 21 of Ley N° 90: (1) emergency situations caused by public disasters and natural disasters; (2) humanitarian reasons, where needed by persons with rare conditions in the country to begin or continue treatment; (3) no supply on the local market combined with a public health need; (4) research and teaching purposes; and (5) demonstration at trade fairs and temporary exhibitions, for a maximum of 90 days. The precondition is that the supplier applies and a public or private health entity requiring the product provides a technical justification.

• Exemption is not automatic: it requires an application plus a technical justification from the entity that needs the product.
• The 90-day limit is written into the fifth case only and does not extend to the other four.
• Cases one and two are situational by their own wording, which excludes reading them as long-term authorisations.
• Demonstration equipment and prototype equipment have different compliance positions under the DE 490 definitions.
• The orphan device is a defined concept that pairs with the humanitarian exemption and gives it a name in the rules.
• Each authorisation should be filed separately, with its reference, period and actual use recorded.

2. Legal basis

Article 21 opens with the procedural precondition and then lists the five cases. The definitions in DE 490 supply the categories that attach to cases four and five, and to the humanitarian ground in case two.

3. Expert insights

Insight 1. The trigger for all five cases is an application plus a technical justification, not automatic application. The preamble to Article 21 requires two actions: the supplier applies, and the public or private health entity requiring the product provides a technical justification (fundamentada técnicamente por la entidad de salud pública o privada requirente). Exempt import is therefore not a matter of declaring the intention at customs; it is an approval that requires the cooperation of a local user. A trade fair exhibit without the backing of a local health entity cannot, as a matter of law, satisfy the requirement, which is a practical constraint that exhibition organisers rarely mention to exhibitors.

Insight 2. The 90 days bind the fifth case only and cannot be extended to the other four. The text places “hasta un periodo de noventa días” expressly inside item 5, the trade fair case. The first four cases carry no statutory time limit, but neither do they imply long-term authorisation: items 1 and 2 are framed as responding to an emergency and as beginning or continuing treatment, which are situational and inherently limited by their own terms. Treating 90 days as a uniform period for all exempt imports is a common misreading, and it tends to appear in planning documents that list the five cases as if they shared a common regime.

Insight 3. The DE 490 definitions draw a line between demonstration equipment and prototype equipment. Definition 45 describes biomedical equipment for demonstration as equipment used to promote the technology. Definition 46 describes prototype biomedical equipment as equipment at the trial stage, not yet used for service or demonstration, and without a certificate of free sale from the competent authority of the country of origin. Their compliance positions differ: demonstration equipment can be imported temporarily under Article 21, item 5, while prototype equipment, lacking a certificate of free sale, faces a more complicated route and is usually placed under item 4, research and teaching. Choosing the wrong item at the outset is difficult to correct later in the process.

Insight 4. The orphan device in definition 28 is an independent concept that pairs with the humanitarian exemption. Definition 28 of DE 490 defines the “dispositivo médico huérfano” as a device exempt from registration on humanitarian grounds. The concept corresponds to Article 21, item 2, and provides an institutional outlet for devices intended for rare conditions. For companies working in that space, Panama offers a route that is set out in a definitional provision rather than left to administrative discretion, which is not common in Central America and is worth identifying early in a product assessment.

4. Practical recommendations

• Before an exempt import, establish whether a technical justification from a local health entity is needed, and approach the user in advance.
• Plan the entry, exit and return of exhibition items against the 90-day ceiling; goods that overrun must move to a regular route or be re-exported.
• Apply for prototype equipment under the research and teaching case, and do not use the demonstration equipment route for it.
• For rare-condition devices, assess the orphan device route and prepare the humanitarian grounds together with the technical justification.
• File each exempt import authorisation separately, recording the approval reference, the period and the actual use, so that later checks can be answered.

5. Verification checklist

• □ Confirm that the case falls within one of the five situations (Article 21, items 1–5)
• □ Obtain the technical justification from the local public or private health entity
• □ For trade fair demonstration, confirm that the period does not exceed 90 days
• □ Distinguish demonstration equipment (definition 45) from prototype equipment (definition 46)
• □ For rare-condition devices, assess the orphan device route (definition 28)
• □ File each authorisation separately and track its expiry

Related reading: [The no-prior-testing principle: Article 15 of Ley 90 and its exceptions](/panama-medical-device-registration/no-prior-analysis-rule-panama/) | [The transitional status of legacy CCTs under DE 468 of 2007: Article 22 of Ley 90](/panama-medical-device-registration/decreto-468-legacy-cct-transition/) | [The twelve labelling items and the prohibition on re-labelling or over-labelling](/panama-medical-device-registration/labelling-12-items-no-re-labelling-panama/)

Regulatory information verified as of October 29, 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 registration applications, prepares Spanish-language dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com