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Service Regulation in Uruguay

Manufacturers of medical devices that wish to distribute and market their products in Uruguay must comply with Uruguayan legislation, that is, for a medical device to enter the country, it must obtain the health registration issued by the country’s health authority (Ministry of Public Health – M.S.P.).

Passarini Group, through its technical team in Uruguay, offers the comprehensive advice and support you need to comply with the regulatory framework in all its stages.

Discover some of the services we provide in Uruguay:

We register the following products: Cosmetics, Medicines, Therapeutic Devices, Diagnostic Reagents, Medical Equipment, Domestic Sanitary Products, Modified Foods and Dietary Supplements. All before the Ministry of Public Health of Uruguay.

We work together with our legal advisors or the contracting company in generating proposals for the creation or modification of regulations.

We generate alerts to our clients in the face of regulatory changes that may impact their operations.

We prepare reports on regulations under public consultation or recently enacted.

Our company is in a position to immediately register and be the owner and importer of the following types of products:

  • Foods
  • Cosmetics and related
  • Sanitizers for domestic use
  • Therapeutic devices
  • Diagnostic reagents

A professional from our company can perform Technical Management with the support of our professional and technical team.

  • Implementation and coordination of the quality assurance system.
  • Leadership of the recall process and associated decisions where appropriate.
  • Supervising/performing internal audits or self-inspections.
  • Maintenance of company authorizations before the health authority.
  • Attention to technical questions.
  • Supervision of the product destruction process.

See below our complete MSP process flow

Passarini Group is a company that has the best specialists in Regulatory Consultancy of Medical Products, applying the One Stop Shop concept daily in your company with practical solutions.

Contact us for more information about to how obtain your service regulation in Uruguay.