Nivel de conocimiento sobre la normativa en el Perú para el registro sanitario de los dispositivos médicos en los alumnos de noveno ciclo y alumnos de la segunda especialidad de Asuntos Regulatorios de la Facultad de Farmacia y Bioquímica de la Universidad Norbert Wiener en el periodo 2017-II

Abstract

The objective of this research was to determine the level of knowledge regarding Peruvian regulations for the sanitary registration of medical devices among ninth-cycle undergraduate students and second-specialty postgraduate students in regulatory affairs at the Faculty of Pharmacy and Biochemistry of Universidad Norbert Wiener. This observational, cross-sectional study was conducted over a three-month period, from December 2017 to February 2018, in classroom settings. Surveys were administered to both undergraduate and postgraduate students, and a total of 65 completed surveys were obtained. The questions were based on current Peruvian regulatory frameworks. The results obtained indicate the following: For Law No. 29459, among undergraduate students, 63.2% demonstrated a deficient level of knowledge, 26.3% a regular level, and 10.5% an optimal level, with none achieving an excellent level. Among postgraduate students, 25.0% demonstrated a deficient level, 50.0% a regular level, 5.3% deficient level, 8.8% optimal, and 1.8% excellent. Another evaluation among postgraduate students showed 75.0% deficient level, none regular, 12.5% optimal, and 12.5% excellent. Regarding Amendments to the law, 77.2% of undergraduate students exhibited a deficient level, 14.0% a regular level, 8.8% optimal, and none excellent. Among postgraduate students, 87.5% were deficient, 12.5% regular, with none at the optimal or excellent levels. For TUPA regulations, undergraduate students scored 52.6% deficient, 35.1% regular, none optimal, and 12.3% excellent. Postgraduate students scored 37.5% deficient, 62.5% regular, with none achieving optimal or excellent levels. Finally, regarding the knowledge of sanitary registration regulations for medical devices, 82.5% of undergraduate students demonstrated a deficient level, 15.8% regular, 1.8% optimal, and none excellent. Among postgraduate students, 75.0% were deficient and 25.0% regular, with none achieving optimal or excellent levels. In conclusion, the study demonstrates that both undergraduate and postgraduate students have predominantly deficient knowledge regarding Peruvian regulations for medical device registration, with only a small percentage achieving regular or optimal levels. These findings highlight the need for enhanced training and educational initiatives in regulatory affairs within the Faculty of Pharmacy and Biochemistry.

Al realizar el trabajo de investigación fue determinar el nivel de conocimiento de la normativa Peruana para el registro sanitario de los dispositivos médicos en los alumnos noveno ciclo, y alumnos de segunda especialidad de asuntos regulatorios Facultad de Farmacia y Bioquímica de la Universidad Norbert Wiener. Este estudio es de diseño observacional – transversal, realizándose periodo de tres meses Diciembre 2017 – Febrero 2018 en las aulas de clases donde se realizaron encuestas a los turnos pregrado y postgrado que están registrados obteniéndose un total de 65 encuestas como muestra donde se evaluó las preguntas basadas en la normativa Peruana obteniéndose lo siguiente: Resultados: Ley Nº 29459 Pregrado 63,2% deficiente nivel, 26,3% nivel regular, 10,5% nivel óptimo ninguno excelente y Postgrado, 25,0% deficiente nivel, 50,0% nivel regular, deficiente nivel, 5,3% nivel regular 8,8% nivel óptimo 1,8% nivel excelente Postgrado, 75,0% deficiente nivel, ninguno nivel regular, 12,5% nivel óptimo, 12,5% nivel excelente Modificatorias Pregrado 77,2% deficiente nivel, 14,0% nivel regular, 8,8% nivel óptimo ninguno nivel excelente Postgrado, 87,5% deficiente nivel 12,5% nivel regular, ninguno presenta nivel óptimo nivel excelente Tupa Pregrado 52,6% deficiente nivel, 35,1% nivel regular, ninguno nivel óptimo 12,3% nivel excelente Postgrado, 37,5% deficiente nivel, 62,5% nivel regular ninguno presenta nivel óptimo nivel excelente Conocimiento normativa registro sanitario dispositivos médicos Pregrado, 82,5% deficiente nivel, 15,8% nivel regular, 1,8% nivel óptimo ninguno nivel excelente Postgrado, 75,0% deficiente nivel , 25,0% nivel regular presenta nivel óptimo nivel excelente.