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
considering paragraph 3 of art. 111 of the Internal Regulation approved by Administrative Rule no. 593 of August 25, 2000, republished in the Official Gazette of December 22, 2000; considering the arts. 12 and 25 and 50 of Law no. 6,360, of September 23, 1976, c / c, arts. 14, 35 and 75 of Decree No. 79.094 of January 5, 1977, c / c RDC-185, of October 22, 2001; considering items I, IV, V, X and XXIX of art. 10, of Law no. No. 6,437, August 20, 1977; considering the decision rendered to fls. 40 in the case file 25351.014843 / 2003-95
원인
Do not have registration with anvisa, imposing health risk.
조치
Determine, as a measure of health interest, throughout Brazil, the prohibition of advertising and publicity, exposure to the sale and sale of the product LASER LIGTH, of KONDORTECH EQUIPAMENTOS ODONTOLÓGICOS LTDA, located at Rua Gastão Vieira nº 471, Jardim Santa Felicia, São Carlos / SP, for not having registered with ANVISA, imposing health risk.