In vitro reagents for research, orphan in vitro diagnostic reagents, analytical grade in vitro
reagents, analyte-specific reagents, and reagents for general laboratory use
(30.02.10.33.00, 30.02.90.20.00, 30.06.20.00.00, 38.21.00.00.00, 38.22.00.90.00)

Proyecto de Resolución del Ministerio de Salud y Protección Social "Por la cual se establece el
reglamento técnico sobre los requisitos que debe contener la etiqueta de los reactivos in
vitro para investigación, in vitro huérfanos para diagnóstico, in vitro grado analítico, analito
específico, y los reactivos de uso general en laboratorio, que sean utilizados en muestras
de origen humano" (Draft Resolution of the Ministry of Health and Social Welfare
establishing the technical regulation on the labelling requirements for in vitro reagents for
research, orphan in vitro diagnostic reagents, analytical grade in vitro reagents, analytespecific
reagents, and reagents for general laboratory use, which are used in samples of
human origin) (5 pages, in Spanish)

The notified text establishes the labelling requirements for in vitro reagents for research, orphan in vitro diagnostic reagents, analytical grade in vitro
reagents, analyte-specific reagents, and reagents for general laboratory use. It covers the
following: Purpose and scope; definitions; general labelling requirements; specific labelling
requirements; declaration of conformity; conformity assessment procedure; authorization
for depletion of stocks of labels and use of adhesives; review and updating; inspection,
monitoring and control; and period of validity.