Events

Categorization of notifications in Technovigilance. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 N/A 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    2006
  • 날짜
    2016-10-18
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    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.
  • 원인
    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.
  • 조치
    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.
  • 모델명 / 제조번호(시리얼번호)
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA