Ministry of Health · AmericasEvery Panama dataset, comparison, and AI workpaper we maintain — one entry point for the whole market.
Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Panama requirements.
Follow recent Ministry of Health — National Directorate of Medical Devices policy, guidance, safety, and compliance updates.
Check the DNDM operating licence tasas fixed by Decreto Ejecutivo 490 for manufacturers, conditioners, distributors, retailers, and warehouses.
Describe your device and get a preliminary DIGEMISA risk class with official rule references.
The two working-day clocks Decreto 490 puts on the DNDM while device sanitary registration stays deferred.
Common questions about changing a registered medical device in Panama. Each question separates published rules from details still awaiting verification.
24 of 25 research dimensions currently covered · 11 official sources · latest verification 2026-09-16
DNDM (MINSA) registration fees in PAB · reviewed 2026-08-25
Dirección Nacional de Dispositivos Médicos, Ministerio de Salud (Ministry of Health) review clocks and planning ranges · 4-class (A, B, C, D) — GHTF/IMDRF rules, Decreto Ejecutivo 490 Art. 30 classification
| Class / pathway | Review clock | Planning total | Provenance |
|---|---|---|---|
| All classes — establishment licence (licencia de operación)(DNDM operating licence, required before any device may be imported, manufactured, stored or sold) Art. 20: applications for issue, update, renewal and correction are decided within 45 working days once the requirements are shown to be met If the DNDM asks for additional information the applicant gets a further 45 working days, and silence is treated as withdrawal Art. 13: the licence runs five years and renewal must be filed 60 working days before expiry | 45 working days | 3-6 months | Verified |
| All classes — technical-criterion certificate (certificado de criterio técnico)(DNDM product certificate, required for purchase by public health institutions) Art. 24: the DNDM answers within 30 working days of complete documentation; after a request for corrections the applicant has 60 working days and the DNDM then has a further 30 working days Art. 21: the certificate runs five years and, for public procurement, is issued free of charge Art. 31: Class C and D evaluations must convene two or more clinical specialists who use the device; for Class A and B that step is optional | 30 working days | 2-5 months | Verified |
Newest official Ministry of Health headlines from the daily-refreshed feed — every row links directly to the authority publication.
PanamaAug 31MOMinistry of Health — National Directorate of Medical DevicesResolution No. 07 Repealing Resolution No. 16 of 2018 on Specific Regulatory DirectivesPanamaThe target market is carried into each tool. Add the product, evidence, or regulatory change you want to assess.
Structure company, product, model, approval, certificate, and evidence facts before starting Panama work.
Connect the Ministry of Health route, evidence, labels, local role, timing, and dependencies to a wider launch plan.
Compare an existing authorization and evidence set against Ministry of Health administrative, testing, labeling, and dossier needs.
Map a product or manufacturing change to Ministry of Health evidence, notification, timing, and implementation questions.
Assess a current Ministry of Health update against one product and turn it into an owner-ready action workpaper.
Review connected-device architecture, risks, SBOM, testing, lifecycle controls, and market-specific questions for Panama (Ministry of Health).
Argentina
Bolivia
Brazil
Canada
Chile
Colombia
Costa Rica
Cuba
Dominican Republic
Ecuador
El Salvador
Guatemala
Honduras
Mexico
Nicaragua
Paraguay
Peru
United States
Uruguay
Venezuela