Operating Licence Application: Seven Documents and a Forty-Five Working Day Decision

1. Key takeaways

The Panamanian operating licence application rests on seven items listed in Article 17 of Decreto Ejecutivo N° 490 as amended by Article 1 of Decreto Ejecutivo N° 416, which reduced the list from eight to seven: the application form, a simple copy of the legal representative’s identity document, a simple copy of the public registry certificate issued within the preceding three months, a sworn statement, a sketch or map showing the location of the premises, a list of the devices intended to be handled, and proof of payment, with item seven waived for Panamanian public institutions. The statutory decision period is no more than forty-five working days under Article 20, with a further forty-five working days where corrections are required; a file not completed in that period is treated as withdrawn and must be filed afresh.

Two features of this file deserve attention before any document is prepared. The list is closed: the amendment removed the catch-all item that had allowed the regulator to add requirements by regulation. And the sworn statement is not a formality attached to the pack but the instrument through which every other statement becomes legally attributable to the signatory, while also authorising present and future inspection.

• Seven items, not eight — the eighth item of the original Article 17 was deleted by Article 1 of DE 416, so citing the article without noting the amendment misstates the file.
• Public registry certificate — issued within the preceding three months, with DE 416 adding the qualifier cuando aplique.
• Sworn statement — certifies that all information and documentation supplied is true and authorises current or future inspection by DNDM.
• Location sketch — a plan or map of the premises, preferably with coordinates, which inspectors later test against reality.
• Device list — the devices and related products already sold and/or intended to be sold, signed by the legal representative or agent.
• Proof of payment — required except for Panamanian public institutions, expressly exempted from item seven.
• Forty-five plus forty-five working days — the decision and correction periods are separate allowances, and expiry of the second is treated as withdrawal.

2. Legal basis

Article 17 of DE 490 sets out the documentary requirements and was amended by Article 1 of Decreto Ejecutivo N.º 416 of 13 May 2020, whose final sentence exempts Panamanian public institutions from item seven. Article 19 confers inspection powers, Article 20 governs timing and withdrawal, and Article 18 permits delegation of activities to third parties subject to conditions.

3. Expert insights

Insight one: DE 416 reduced the file from eight items to seven by deleting a catch-all clause. The original item 8 read otros requisitos que la Dirección Nacional de Dispositivos Médicos establezca mediante reglamentación, an open-ended provision allowing further requirements to be created below the level of the decree. DE 416 removed it, added cuando aplique to item 3 and exempted public institutions from the payment proof. The direction of travel is a closed list and less administrative discretion, so the seven items are exhaustive and cannot be supplemented by informal request.

Insight two: the sworn statement in item 4 anchors every later compliance obligation. The text requires the signatory to certify that all information and documentation provided is true (certificar que toda la información y documentación proporcionada es veraz) and to authorise current or future inspection. Article 33 ties all declared information back to that statement, and a breach of the truth requirement can lead to suspension or cancellation of the CCT or the operating licence; Article 69, item 4, lists failure to honour commitments in the sworn statement as a ground for licence suspension. It should therefore be reviewed by the person able to verify each fact, not signed as a formality.

Insight three: the inspection power in Article 19 is broad and may be exercised without notice. The article sets out six triggers: ex officio action, a complaint, a suspicion, a vigilance report, a device incident, or a failure. It expressly provides for inspection sin previo aviso, and requires an acta to be drawn up and a copy handed to the personnel present. This shifts the emphasis from preparing for an announced visit to keeping the premises inspectable at all times.

Insight four: Article 18 allows delegation to a third party, but responsibility does not move with the activity. Manufacturing, conditioning and distribution premises may entrust operations to a third party provided that a notarised copy of the contract is filed, the third party’s address is declared in the application and the sworn statement, and the third party accepts inspection by DNDM. The final sentence is decisive: El representante legal de quien solicite la licencia es quien tendrá la responsabilidad directa ante la DNDM. Outsourcing the warehouse does not outsource the liability.

4. Practical recommendations

• Prepare against the seven-item list as amended by DE 416, and retire any internal template that still reflects the original eight-item version.
• Track the issue date of the public registry certificate and renew it if it will be older than three months at filing.
• Use the standard DNDM format for the sworn statement and have it signed by a person with proper authority and access to the underlying records.
• Maintain the premises to an always-inspectable standard, and file every inspection record received, since the acta is the reference document in any later dispute.
• Where activities are delegated, complete all three conditions together: notarised contract, declared address, third-party acceptance of inspection, and define internal responsibility for the delegated site in writing.
• Diarise the forty-five working day decision point and the separate forty-five working day correction window, so that a returned file is answered well inside the second period.

5. Verification checklist

• □ File assembled against the seven-item list as amended by DE 416
• □ Public registry certificate issued within the preceding three months
• □ Sworn statement in the standard format and expressly authorising inspection
• □ Location sketch or map includes coordinates
• □ Device list signed by the legal representative or authorised agent
• □ Proof of payment attached, or the public institution exemption documented
• □ Forty-five working day decision point and correction window both tracked
• □ Delegated activities supported by notarised contract and declared address (Article 18)

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