Propuesta de un Procedimiento Operativo Estándar para la inscripción y/o reinscripción de un dispositivo medico de una droguería. Lima – 2021
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Date
2022
Journal Title
Journal ISSN
Volume Title
Publisher
Universidad Nacional de Trujillo
Abstract
El presente informe de Prácticas Pre Profesionales tuvo como objetivo elaborar una propuesta de un Procedimiento Operativo Estándar (POES) para la inscripción y/o reinscripción de un dispositivo médico de una droguería, Lima, la cual permite la obtención y el mantenimiento del Registro Sanitario de los dispositivos médicos. Por ello, se hizo una búsqueda de información en base a los requerimientos del “Reglamento para el registro, control, y vigilancia sanitaria de productos farmacéuticos, dispositivos médicos y productos sanitarios”, de la Ley N°29459 “Ley de los productos farmacéuticos, dispositivos médicos y productos sanitarios”, Texto Único de Procedimientos Administrativos (TUPA) y Ventanilla Única de Comercio Exterior (VUCE). El resultado fue el documento del POES, el cual tiene una estructura de: Hoja principal, objetivo, alcance, responsabilidad, términos y definiciones, referencia documentaria, frecuencia, materiales y/o equipos, precauciones, procedimiento, distribución, control histórico de cambios y anexos.
ABSTRACT The objective of this Pre-Professional Practices report was to elaborate a proposal for a Standard Operating Procedure (SOP) for the registration and/or re-registration of a medical device of a drugstore, Lima, which allows obtaining and maintaining the Sanitary Registration of medical devices. Therefore, a search for information was made based on the requirements of the "Regulation for the registration, control, and sanitary surveillance of pharmaceutical products, medical devices and sanitary products", Law N°29459 "Law of pharmaceutical products, medical devices and sanitary products", Single Text of Administrative Procedures (TUPA) and Single Window of Foreign Trade (VUCE). The result was the SOP document, which has a structure of: Main sheet, objective, scope, responsibility, terms and definitions, documentary reference, frequency, materials and/or equipment, precautions, procedure, distribution, historical control of changes and annexes
ABSTRACT The objective of this Pre-Professional Practices report was to elaborate a proposal for a Standard Operating Procedure (SOP) for the registration and/or re-registration of a medical device of a drugstore, Lima, which allows obtaining and maintaining the Sanitary Registration of medical devices. Therefore, a search for information was made based on the requirements of the "Regulation for the registration, control, and sanitary surveillance of pharmaceutical products, medical devices and sanitary products", Law N°29459 "Law of pharmaceutical products, medical devices and sanitary products", Single Text of Administrative Procedures (TUPA) and Single Window of Foreign Trade (VUCE). The result was the SOP document, which has a structure of: Main sheet, objective, scope, responsibility, terms and definitions, documentary reference, frequency, materials and/or equipment, precautions, procedure, distribution, historical control of changes and annexes
Description
Keywords
Procedimiento Operativo Estándar, inscripción, reinscripción, dispositivos médicos, ANM.