Competent authority
authority.competent-authority
Ministry of Public Health — Medical Technology Evaluation Department
Ministry of Public Health · structured requirements
🇺🇾 Uruguay medical device regulatory data
Explore the medical device requirements currently available for Uruguay, organized by topic and linked to official sources.
4 facts4 dimensions1 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 Public Health — Medical Technology Evaluation Department
- SubmissionSurface
VUCE/PIRM electronic transfer plus MSP product-specific forms
- VerifiedHighlights
- MSP publishes separate registration forms for diagnostic reagents, therapeutic devices and medical equipment.
- The official surface includes registration/renewal, customs-negative certificate and compassionate-use procedures.
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
VUCE/PIRM electronic transfer plus MSP product-specific forms
- VerifiedHighlights
- MSP publishes separate registration forms for diagnostic reagents, therapeutic devices and medical equipment.
- The official surface includes registration/renewal, customs-negative certificate and compassionate-use procedures.
Registration pathways
Which registration, notification, listing, reliance, or conformity route applies?
Market-access route or official registration surface
registration.market-access-route
- SubmissionSurface
VUCE/PIRM electronic transfer plus MSP product-specific forms
- VerifiedHighlights
- MSP publishes separate registration forms for diagnostic reagents, therapeutic devices and medical equipment.
- The official surface includes registration/renewal, customs-negative certificate and compassionate-use procedures.
Need to apply Uruguay's requirements to a product?
Confirm the current Ministry of Public Health pathway, evidence, and local-role details for the actual device before filing.