%0 Journal Article
%T PROPUESTA DE CLASIFICACION PARA LOS DIAGNOSTICADORES POR CATEGORIAS DE RIESGO Classification proposal for diagnosers in risk categories
%A Kenia Mar赤a Rodr赤guez Oropesa
%A Manuel Morej車n Campa
%A Gipsis Su芍rez Rom芍n
%J Revista Habanera de Ciencias Mˋˋdicas
%D 2009
%I Ministerio de Salud Publica
%X El presente trabajo, insertado dentro del perfil administrativo, surge debido a que en Cuba no existe una clasificaci車n oficial para los diagnosticadores de acuerdo con las categor赤as de riesgo; no hay un tratamiento diferenciado en su proceso de comercializaci車n. Adem芍s, los requisitos que se exigen para el Registro Sanitario de los Diagnosticadores son b芍sicamente semejantes para todos. Por tal motivo, se realiz車 una investigaci車n documental. Se recurri車 a las fuentes bibliogr芍ficas disponibles, revis芍ndolas objetivamente e interrelacionando los diferentes puntos de vistas existentes; criticando cient赤ficamente las distintas posiciones, asumiendo puntos de vistas propios acorde con nuestras condiciones y situaci車n particular. El proceso de investigaci車n que se llev車 a cabo para la elaboraci車n de la Clasificaci車n de los Diagnosticadores por Categor赤as de Riesgo, implic車 una serie de acciones necesarias, tales como: realizaci車n de una propuesta de Clasificaci車n inicial de los diagnosticadores y confecci車n de un algoritmo para aplicar dicha clasificaci車n; se logr車, de esta manera, agilizar los tr芍mites de registro; facilitar la preparaci車n de la documentaci車n requerida para solicitar el Registro Sanitario y dirigir la atenci車n de la actividad reguladora sobre aquellos productos de mayor riesgo. 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.
%K Clasificaci車n
%K diagnosticadores
%K categor赤as de riesgo
%K Regulaci車n.
%K Classification
%K Diagnostic Kits
%K Categories of Risk
%K regulating activity
%U http://scielo.sld.cu/scielo.php?script=sci_arttext&pid=S1729-519X2009000300008