Events

Alerte De Sécurité sur Surgical gloves and Gloves for non-surgical procedures must meet the technical requirements defined by the Brazilian certification body (Inmetro), have the manufacturing batch number and number of the CA printed on each glove, as well as the Conformity Identification Seal on the packaging .

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
    990
  • Date
    2009-10-06
  • 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 list of certified products is available on the Inmetro website, as follows: 1. http://www.inmetro.gov.br/prodcert/produtos/lista.asp. (surgical gloves and gloves for non-surgical procedures); 2. http://www.inmetro.gov.br/prodcert/produtos/lista.asp. (Surgical Gloves) RDC Anvisa 5/2008 and Portaria Inmetro 233/2008 are available on the websites of the respective Institutions: www.anvisa.gov.br and www.inmetro.gov.br Anvisa has provided a text with the most frequently asked questions about the process, which can be accessed at http://www.anvisa.gov.br/produtosaude/perguntas_respostas/luvas.pdf
  • Cause
    The systematic monitoring of the behavior of the gloves in the brazilian market, through the technovigilance, indicating that both the surgical gloves and the non surgical procedures had been presenting problems of quality and safety pointed to the necessity of adopting strategies to strengthen product regulation in brazil. in this way, anvisa defined as mandatory the certification of these products, according to rdc nº. 05, dated february 15, 2008, whose procedures for certification are regulated by inmetro ordinance no. 233, dated june 30, 2008. thus, it is regulated that as of september 1, 2009, only surgical gloves and non-surgical procedures may be marketed in brazil, and failure to comply with this requirement constitutes a sanitary infraction.
  • Action
    The RDC 5/2008 approves the Technical Regulation that establishes the minimum requirements that must be obeyed by surgical gloves and gloves of non-surgical procedures of natural rubber, synthetic rubber and rubber mixture, and also makes the certification of these products mandatory. of the Brazilian Conformity Assessment System (SBAC). The INMETRO Ordinance no. 233 of June 30, 2008, approves the Conformity Assessment Regulation, where the procedures for certification are established.

Device

Surgical gloves and Gloves for non-surgical procedures must meet the technical requirements defin...
  • Modèle / numéro de série
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA