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tesis de grado
Publicado 2019
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The objective of this study was to determine similarities and differences in the requirements for the registration of medical devices of the regulatory entity DIGEMID and the national regulatory authorities of reference (INVIMA, ANMAT, ANVISA, CECMED, COFEPRIS), for which proceeded to perform the bibliographic search, and obtained the results presented in comparative tables between the regulatory entity of Peru and each of the national regulatory authorities of reference considered for the study. The results showed that the requirements requested by DIGEMID for the registration of sanitary registration of medical devices in Peru are similar to the national regulatory authorities of reference; However, INVIMA, ANMAT, ANVISA, CECMED, COFEPRIS present requirements with greater rigor and emphasis on the safety aspect of medical devices when requesting different tests, studies, tests, reports...