Events

Alerta De Seguridad para Categorization of notifications in Technovigilance.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por N/A.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    2006
  • Fecha
    2016-10-18
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Notas adicionales en la data
    The public consultation is open for contributions to the terminology proposal for categorization of notifications in Tecnovigilância. This is the proposal developed under the IMDRF (International Medical Device Regulators Forum). The deadline to submit contributions ends on 12/12/2016.
  • Causa
    Imdrf - terminologies for categorization of notification in technovigilance the proposal of terminology for categorization of notifications in technovigilance (terms, terminology and codes) was developed by the working group composed of representatives of participating countries of the international medical device regulators forum (imdrf), among the which, brazil. the final document should contain four annexes - annex a (product problem); annex b (cause investigation); appendix c (patient problem) and annex d (parts / components). annex a was completed by the working group and was presented to the steering committee in september. annex a (product problem) is in public consultation, and contributions may be submitted by 12/2/2016. this proposal was elaborated from iso 19.218-1 and from the document of the fda / usa, resulting in the categorization in three levels, the third one that more detail the occurrence. since 2015, anvisa has been guiding the companies that register health products to classify notifications according to the standards abnt nbr iso 19.218-1 (notification) and 19.218-2 (conclusion of the investigation). as such, these companies already have experience with the use of these codes and could contribute to the improvement of the imdrf proposal. health services and professionals, the main users of health products, also represent important agents of participation in this public consultation, considering their experience in the use of these products. it is also important to note the importance of the participation of the entities of the national health surveillance system (snvs). the different entities of the snvs follow notifications in technovigilance, perform inspection activities.
  • Acción
    Regulated sector - health companies and services; Health professionals; associations; class entities and SNVS entities, participate in the public consultation by sending their suggestions!

Device

Categorization of notifications in Technovigilance.
  • Modelo / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA