Uruguay medical device registration timeline

Source-linked clocks

Ministry of Public Health (MSP) review clocks and end-to-end planning ranges, using the Device registration under Decree 3/008 classification system.

1 pathways1 of 1 clocks verifiedvalidity 5 yearsMDSAP not acceptedreviewed 2026-08-25

Class / pathway	Review clock	Planning total	With prior approval	Provenance
Medical-device registration(MSP registration) Decree 3/008 Art. 11 sets a maximum 180-day authority clock; observations automatically suspend that clock and the applicant has 90 days to cure before the file is archived	180 days	7-10 months	—	Verified

Review clocks exclude applicant hold time · planning totals are estimates

Uruguay Medical Device Registration Process

Step-by-step MSP registration process. Total estimated timeline: 7-10 months.

Step 1: Pre-Submission Preparation

1-3 months

Gather technical documentation, quality management system (QMS) records, and clinical data required by MSP. Appoint a Uruguayan Authorized Representative.

Step 2: Application Submission

1-2 weeks

Submit complete registration dossier to MSP including device description, risk analysis, and testing reports.

Step 3: Administrative Review

2-4 weeks

MSP reviews application for completeness. May request additional documents or clarifications.

Step 4: Technical Evaluation

180 days

In-depth technical assessment of device safety and performance. MSP may issue questions.

Step 5: Registration Approval

1-2 weeks

Upon successful review, MSP issues Uruguay market authorization certificate.

Summary: The Uruguay medical device registration process through Ministry of Public Health (MSP) consists of 5 main steps: Pre-Submission Preparation → Application Submission → Administrative Review → Technical Evaluation → Registration Approval.

Prior approval recognition

CE Mark (EU MDR)Technical documentation and QMS evidence reuse1-3 months

FDA 510(k)/PMASubmission content reuse as reference evidence

Key requirements

Local Authorized Representative required for foreign manufacturers
Free-sale certificate from country of origin
Registration valid for 5 years (renewable)

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Source-linked review clocks verified against MSP publications · full review 2026-08-25 · row IDs are stable — cite as registration-timeline:uruguay:product-registration