Competent authority
authority.competent-authority
Ministry of Health — National Directorate of Medical Devices
Ministry of Health · structured requirements
🇵🇦 Panama medical device regulatory data
Explore the medical device requirements currently available for Panama, organized by topic and linked to official sources.
4 facts4 dimensions2 official sourceslatest verification 2026-08-13
Legal basis & guidance
Which current law, regulation, guidance, and transition provisions apply?
Official legal and guidance surface
legal-basis.official-surface
- Authority
Ministry of Health — National Directorate of Medical Devices
- SubmissionSurface
MINSA forms and procedures under Law 90 and implementing resolutions
- VerifiedHighlights
- The Directorate's statutory surface covers product registration, establishment licensing, import permits, free-sale certificates, labeling, traceability and vigilance.
- MINSA publishes national medical-device forms and the operative legal framework.
Official forms & portals
Which current form, portal, account, and submission package must be used?
Official form or portal surface
submission.official-form-or-portal-surface
- SubmissionSurface
MINSA forms and procedures under Law 90 and implementing resolutions
- VerifiedHighlights
- The Directorate's statutory surface covers product registration, establishment licensing, import permits, free-sale certificates, labeling, traceability and vigilance.
- MINSA publishes national medical-device forms and the operative legal framework.
Registration pathways
Which registration, notification, listing, reliance, or conformity route applies?
Market-access route or official registration surface
registration.market-access-route
- SubmissionSurface
MINSA forms and procedures under Law 90 and implementing resolutions
- VerifiedHighlights
- The Directorate's statutory surface covers product registration, establishment licensing, import permits, free-sale certificates, labeling, traceability and vigilance.
- MINSA publishes national medical-device forms and the operative legal framework.
Need to apply Panama's requirements to a product?
Confirm the current Ministry of Health pathway, evidence, and local-role details for the actual device before filing.