Uruguay Medical Device Regulations

Agency
All medical devices are regulated by Ministerio de Salud Publica (MSP)
Medical Device Definition
Medical devices are instruments, implements, appliances, implants, materials or other similar or related article, used alone or in combination in humans to:
  1. Diagnosis, prevention, monitoring, treatment or alleviation of disease or injury;
  2. Research;
  3. Substitution or support of the anatomical structure or physiological process;
  4. Support and sustain life;
  5. Birth control;
  6. In vitro examination of specimens derived from the human body and do not meet their basic action provided in or on the human body by pharmacological or metabolic means, but which may be assisted in its function by such means.
Classification of Medical Device
1 2 3 4 5 6
Premarket Approval Process
Uruguay is a part of MERCOSUR (Common Southern Market), which also includes Argentina, Brazil,, Paraguay, Venezuela and Bolivia. Mercosur defines Technical Regulation for medical device registration. Uruguay's regulations are harmonized.
Applicant must appoint an Authorized Representative (AR) in Uruguay.
All manufacturers, importers, distributors, or their AR must register with MSP.
Device are required to meet meet quality assurances and may be audited by MSP.
Additional Information
Premarket Evaluation Required
Manufacturing Controls None in place
Validity Five Years
Conformity Assessment Required
Timeline Official: 6 months Actual: 10-12 months
Post-Market Surveillance Medical device reporting
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