Resumen

RODRIGUEZ OROPESA, Kenia María; MOREJON CAMPA, Manuel  y  SUAREZ ROMAN, Gipsis. Classification proposal for diagnosers in risk categories. Rev haban cienc méd [online]. 2009, vol.8, n.3. ISSN 1729-519X.

This work, inserted within the administrative profile, is due to the lack in Cuba of an official classification of diagnostic kits for categories of risk; there is no differentiated treatment for their commercialization. In addition, the requirements for the Sanitary Record of the Diagnostic Kits are basically similar to them all. A documentary research was carried out. Available bibliographical sources were objectively revised, and different existent points of view were interrelated. Different positions were scientifically criticized, and own points of view were assumed according to our conditions and particular situation. Research process carried out to elaborate the Regulation: Classification of Diagnostic Kits for Categories of Risk implied a number of necessary actions, such as a proposal for an initial classification of diagnostic kits and an algorithm to apply that classification. A proposal for differentiating the current requirements for categories of risk for the Sanitary Record of Diagnostic Kits was also elaborated. Record procedures were speeded up, the preparation of the required documents to request the Sanitary Record was made easier, and attention was focused towards the regulating activity on those major risk products.

Palabras clave : Classification; Diagnostic Kits; Categories of Risk; regulating activity.

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