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A company has requested clarification on whether its COVID-19 sample collection kit qualifies for the 0% VAT rate. The Directorate-General for Taxes (DGT) has ruled that this rate applies only to in vitro diagnostic medical devices that comply with Directive 98/79/EC or Regulation (EU) 2017/746.
Cuestión planteada Aplicación del tipo impositivo del 0 por ciento al kit para diagnóstico de la SAS.Cov-2 fabricado y comercializado por el consultante.
El tipo del 0% del IVA se aplica exclusivamente a los productos sanitarios para diagnóstico in vitro del SARS-CoV-2 que sean conformes con la Directiva 98/79/CE o el Reglamento (UE) 2017/746. Los recipientes para muestras se consideran productos sanitarios para diagnóstico in vitro si están destinados específicamente a la contención y conservación de muestras para examen diagnóstico. La determinación de si un producto específico cumple con dicha normativa sanitaria corresponde a la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS).
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