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.
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
UNTIL THIS DATE DOES NOT INCLUDE REGISTRATION OF THE PRODUCT IN BRAZIL.
원인
The in-vitro diagnostic medical device for self-diagnosis "romed - hcg test", manufactured by the dutch company romed - van oostveen medical bv and distributed by imporfar, lda., is being marketed in the portuguese market with ce marking, without has been evaluated by a notified body responsible for assessing the conformity of the device with the european directive 98/79 / ec together with other non-conformity with the labeling and package leaflet.
조치
The self-diagnostic device "ROMED - HCG Test", manufactured by the Dutch company ROMED - Van Oostveen Medical BV, does not have the certificate mentioned above and is in a situation of unduly affixing the CE marking. Therefore, INFARMED Pharmacy and Medicinal Products), as Competent National Authority (Portugal) for Medical Devices for In Vitro Diagnosis, decided to withdraw from the national market.