Post-market health surveillance of medical devices “Technovigilance” – El Salvador

by LA | May 5, 2023 | LS

By: Laura Fuentes Technovigilance means medical devices surveillance (MD) at the commercialization use and stage. It involves the systematic collection and adverse events evaluation, incidents and quality failures related to the medical devices use, allowing to...

Vigilancia sanitaria post comercialización de dispositivos médicos “Tecnovigilancia” – El Salvador

by LA | May 5, 2023 | Blog legal LS

Por: Laura Fuentes La Tecnovigilancia se refiere a la vigilancia de Dispositivos Médicos (DM) en la etapa de comercialización y uso. Involucra la recolección y evaluación de manera sistemática de eventos adversos, incidentes y fallas de calidad relacionadas al uso de...

Technical evaluation for sanitary registrations – El Salvador

by LA | May 3, 2023 | LS

By: Laura Portillo The guide for sanitary registration of cosmetic and hygienic products of the National Directorate of Drugs provides a technical evaluation of the application for registration, which may result in the following possibilities: Favorable: if the...

Evaluación técnica para los registros sanitarios – El Salvador

by LA | May 3, 2023 | Swift Advisory LS

Por: Laura Portillo Según la guía para registro sanitario de productos cosméticos e higiénicos de la Dirección Nacional de Medicamentos, existen una evaluación técnica a la solicitud de inscripción, las cuales pueden resultar en las siguientes posibilidades:...

Categories to determine the Medical Device Nature according to the DNM – El Salvador

by LA | May 3, 2023 | LS

By: Cindy Lazo – In Vitro Diagnostic Agents (IVD): May be a reagent, calibrator, control material or kit, used alone or in combination. Intended by the manufacturer to be used in vitro for the study of samples from the human body. Examples: 1. Glucose test...

Categories to determine the Medical Device Nature according to the DNM – El Salvador

by LA | May 3, 2023 | LS

By: Cindy Lazo – In Vitro Diagnostic Agents (IVD): May be a reagent, calibrator, control material or kit, used alone or in combination. Intended by the manufacturer to be used in vitro for the study of samples from the human body. Examples: Glucose test strips...