Panama medical device registration resources

Competent authority

The Ministry of Health (Ministerio de Salud, MINSA) is the competent authority for regulating medical devices and related products, including infractions and sanctions; it exercises this th…

DNDM operational functions

DNDM's functions include issuing the Registro Sanitario, the special import permit (permiso especial de importación) for devices, certifying the Licencia de Operación and the Good Manufactu…

Pending replacement reglamento (draft)

A draft executive decree re regulating Ley 90 (as amended by Ley 92) was published by MINSA on 15 Oct 2025 for public consultation; at CCIAP's request the consultation was extended (MINSA n…

Current legal framework

Framework in force: Ley 90 de 26 Dec 2017 (Gaceta 28433 B); amended by Ley 92 de 12 Sep 2019; regulated by Decreto Ejecutivo 490 de 4 Oct 2019 (Gaceta 28875 A), as modified by Decreto Ejecu…

IVD and related products ('productos afines') in scope

In vitro diagnostic devices (reagents, calibrators, control materials, sample containers, software, instruments) are regulated devices. 'Productos afines a dispositivos médicos' (spare part…

Medical device definition (includes software)

'Dispositivo médico' means any instrument, apparatus, implement, machine, implant, in vitro reagent, software, material or other similar or related article intended by the manufacturer for…

Risk classes A through D per the most current GHTF/IMDRF classification (Ley 90 de 2017).

Clase A, Clase B, Clase C, Clase D

Legacy Certificado de Criterio Técnico transition

Certificados de Criterios Técnicos valid at Ley 90's promulgation (issued under DE 468 de 7 Nov 2007) are treated as valid Registro Sanitario and Certificado de Criterio Técnico and keep th…

Registro Sanitario requirement

The Registro Sanitario de Dispositivos Médicos, issued by DNDM, authorizes import, export, marketing and public/private use of a device once the applicant demonstrates with documented evide…

China NMPA approval: origin evidence only

statement: Decreto Ejecutivo 490 of 4 October 2019 (Gaceta Oficial 28875 A), which regulates Ley 90/2017, requires in Art. 36 numeral 11 a valid Certificate of Free Sale issued by the compe…

Reliance on reference authorities

DNDM may issue the Registro Sanitario through expedited validation and acceptance of certifications issued by reference authorities recognized by the competent health authority, subject to…

Operator roles and licence duty

Ley 90 defines the Fabricante (designs, manufactures, conditions and labels the finished product) and the Importador (brings the product into Panama for commercialization, donation, demonst…

Establishment verification and inspections

DNDM verifies that premises meet infrastructure, equipment, hygiene and environment conditions for the regulated activities, recording an acta of the premises' fitness; it may inspect estab…

Import shipment data and tariff treatment

Every device consignment entering or leaving Panama must carry (verified on the invoice and related documents): manufacturer name; importer/exporter name and address; invoice number; trade…

No source-verified answer is published for this dimension yet.

Official DNDM forms

MINSA publishes the current DNDM forms: Formulario de Declaración Jurada, Formulario Listado de Dispositivos Médicos a Comercializar, and Formulario de Solicitud de Licencia de Operación, p…

No source-verified answer is published for this dimension yet.

Good-practice certificates

DNDM is authorized to issue Certificados de Buenas Prácticas de Fabricación, de Almacenamiento and de Distribución and to regulate their issuance; Resolución 852 de 30 Oct 2019 approved the…

ASEP homologación of telecommunications equipment

Wireless / radio

IEA reference-laboratory quality-control analysis

Product-specific

Licencia de Operación - Fabricante

B/. 350

Licencia de Operación - Acondicionador

B/. 225

All classes — establishment licence (licencia de operación) · DNDM operating licence, required before any device may be imported, manufactured, stored or sold

45 working days

All classes — technical-criterion certificate (certificado de criterio técnico) · DNDM product certificate, required for purchase by public health institutions

30 working days

Validity and renewal (pending draft)

Pending draft decree: Certificado de Registro Sanitario valid five years from issuance, renewable for five years on application up to 120 working days before expiry (Arts. 62 63); class A i…

Software updates and spare parts

Software and other updates that do not change the device's function do not require a change or update of the Registro Sanitario; spare parts, accessories and consumables are covered by the…

Implantable device traceability

Traceability of implantable medical devices is mandatory (DE 490, Chapter IV, Art. 62). Health institutions must complete the Registro Nacional de Dispositivos Médicos Implantables y Prótes…

Public registry database

DNDM must maintain an updated, public database on MINSA's website covering Licencias de Operación, Certificados de Libre Venta, Registros Sanitarios, Certificados de Criterios Técnicos, BPM…

No source-verified answer is published for this dimension yet.

Donations framework

Decreto Ejecutivo 48 de 12 de abril de 2022 regulates donations of medicines, medical devices, biomedical equipment, medical furniture and other health products, repealing DE 988 de 8 de se…

Import without registration (five cases)

Upon supplier request technically supported by the requiring health entity, DNDM may authorize import of devices without a Registro Sanitario in five cases: (1) emergencies from public cala…

Vigilance system and notification duty

DNDM must design and implement a device vigilance system to prevent, detect and correct irregularities affecting safety/efficacy (norms and guides, training, failure categorization, interve…

Investigation deadline

The investigation process is determined by the risk level of the event, adverse incident or failure, and the investigation period may not exceed ninety working days after complete documenta…

Retention, seizure and sanctions

DNDM may order retention of devices found in non compliant establishments and their seizure (decomiso) by reasoned resolution. Fines range from B/.500 to B/.5,000 (minor faults), B/.5,001 t…

Advertising within regulated scope

Ley 90 places 'información' and 'publicidad' for devices within its regulated activities, and classifies non compliance with prohibitions on ambulatory (street) commercialization of regulat…

Appeal routes

Sanctions imposed under Ley 90 are appealable by recurso de reconsideración and recurso de apelación, both granted in devolutive effect; resolution of the appeal exhausts the governmental a…