Ministry of Public Health · AmericasEvery Uruguay 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 Uruguay requirements.
Follow recent Ministry of Public Health — Medical Technology Evaluation Department policy, guidance, safety, and compliance updates.
Compare official and realistic MSP approval times by device class and pathway.
Check current Ministry of Public Health fee requirements for device market entry.
Describe your device and get a preliminary MSP risk class with official rule references.
Read the MERCOSUR technical regulation internalised by Uruguay, with citeable Spanish passages.
Common questions about changing a registered medical device in Uruguay. Each question separates published rules from details still awaiting verification.
23 of 25 research dimensions currently covered · 16 official sources · latest verification 2026-09-15
Ministry of Public Health registration fees in UYU · reviewed 2026-08-25
| Fee line | Amount | Provenance |
|---|---|---|
| PIRM registration and MSP arancelado fees (indexed UR units) | PIRM: 5 UR fixed + 25 UR families + professional stamps | Planning estimate |
Ministry of Public Health (Ministry of Public Health) review clocks and planning ranges · Device registration under Decree 3/008 classification
| Class / pathway | Review clock | Planning total | Provenance |
|---|---|---|---|
| Medical-device registration(MSP registration) Decreto 3/008 Art. 11 sets a maximum 180-day authority clock running from filing with the Departamento de TecnologÃa Médica Observations automatically suspend that clock and the applicant has 90 days to cure before the file is archived The decree states one product-registration clock and does not allocate separate clocks by risk class Any analysis or testing the review requires is performed at the applicant's cost in an MSP-authorised laboratory, outside the 180-day period | 180 days | 7-10 months | Verified |
| Registration renewal(MSP renewal) Decreto 3/008 Art. 11 applies the same procedures, and therefore the same 180-day maximum, to renewals Renewal must be requested before the registration expires; Art. 13 gives 90 days to cure observations, but on a renewal the expiry of that window means the request is treated as denied rather than merely archived | 180 days | 6-9 months | Verified |
Official Ministry of Public Health rules and guidance · 1 of 1 documents linked to official sources
The 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 Uruguay work.
Connect the Ministry of Public Health route, evidence, labels, local role, timing, and dependencies to a wider launch plan.
Compare an existing authorization and evidence set against Ministry of Public Health administrative, testing, labeling, and dossier needs.
Map a product or manufacturing change to Ministry of Public Health evidence, notification, timing, and implementation questions.
Assess a current Ministry of Public 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 Uruguay (Ministry of Public Health).
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