Events

Alerte De Sécurité sur Categorization of notifications in Technovigilance.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par N/A.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    2006
  • Date
    2016-10-18
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    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.
  • Cause
    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.
  • Action
    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.
  • Modèle / numéro de série
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA