This article was updated May 29, 2025.
This post will tell you more about medical device regulations in Uruguay. Uruguay’s Ministry of Public Health (MSP) regulates medical devices under a framework harmonized with MERCOSUR.
Recent Decree 498/025 (April 2025) fully aligns national requirements with the MERCOSUR essential safety and performance resolution and launches a phased Unique Device Identification (UDI) rollout. Below is an overview of classification rules, registration pathways, quality expectations, and post‑market obligations.
Table of content
Device Classification
MSP adopts MERCOSUR’s six‑tier risk‑based classification for medical devices and a separate four‑tier tree for IVDs:
- Class I – Low risk, non‑invasive (e.g., bandages).
- Class IIa – Low‑to‑medium risk invasive or active devices.
- Class IIb – Medium‑to‑high risk implanted or life‑supporting devices.
- Class III – High risk implants in contact with circulatory/CNS or medicinal action.
- Class IV – Active implantable & life‑sustaining.
- Class VI – Highest risk with direct CNS contact.
- IVD Classes A–D follow MERCOSUR Resolution 02/05.
Risk class determines dossier depth, clinical evidence, review clocks, and inspection requirements.
Medical Device Registration Process
Foreign manufacturers must appoint an Authorized Representative (AR) domiciled in Uruguay.
- Step 1 – Appoint AR and issue notarized Power of Attorney.
- Step 2 – Compile technical dossier (admin forms, device description, risk management, V&V data, clinical evidence, ISO 13485/GMP, Spanish labeling).
- Step 3 – Pay fixed fee of 30 Unidad Reajustable (~USD 1,200) via MSP portal.
- Step 4 – Submit electronically via VUCE or deliver hard copies + USB to MSP.
- Step 5 – MSP review: 3–4 mo (Class I) to 12 mo+ (Class III–VI).
- Step 6 – Receive RG‑MD certificate (valid 5 years).
Renewal: abridged dossier 60 days before expiry; same fee.
Quality Management System (QMS)
MSP recognizes ISO 13485 : 2016 certificates and MERCOSUR GMP.
- Routine audits every 3–5 years.
- CAPA due within 90 days for non‑conformities.
- AR facilities audited to verify import and vigilance records.
Labeling Requirements
Spanish labeling per MERCOSUR Resolution 05/06 and Decree 191/99.
- Device & model, manufacturer & AR names/addresses.
- Intended use, contraindications, warnings.
- Lot/serial, manufacture & expiry dates, storage conditions.
- UDI required for Class IIb+ devices starting Q3 2025.
Post‑Market Surveillance & Vigilance
- Serious incidents: report within 15 calendar days.
- Field Safety Corrective Actions: MSP approval before customer notification.
- Annual vigilance summary due by 31 March.
- Maintain traceability records for 10 years.
Fines from 30–1,000 UR or RG‑MD suspension for non‑compliance.
Clinical Investigation Requirements
Required for Class IIb–VI devices lacking sufficient clinical data.
- Ethics approval from MSP‑registered IRB.
- Conduct per ICH‑GCP; register with ANII if applicable.
- MSP may audit clinical sites.
Latest Regulatory Updates (2025)
- Decree 498/025 aligns Uruguay with MERCOSUR Resolution GMC 07/24.
- UDI guidance expected Q3 2025; phased compliance begins with Class III–VI.
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