심층보고서 // 알기 쉬운 브라질 의료장비·의약품·화장품 인증 // Ⅰ.브라질 인증 발급기관 및 대상품목 Ⅱ.인증 절차 Ⅲ.우리 기업의 ANVISA 인증 취득 사례

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padding: 0px; margin: 0px; vertical-align: top; line-height: 1.2;"><img src="https://img1.daumcdn.net/relay/cafe/original/?fname=http%3A%2F%2Fnews.kotra.or.kr%2Fsite%2Fkotranews%2Fupload%2Freports%2F20161215155813_1481777354234.JPG" alt="업로드이미지" style="box-sizing: border-box; padding: 0px; margin: 0px; vertical-align: top; line-height: 1.2; outline: none; border: 1px solid rgb(212, 212, 212); width: 224px; height: 317px;"></div></div><div class="report-infomation-area" style="box-sizing: border-box; padding: 0px; margin: 0px; vertical-align: top; line-height: 1.2; float: left; width: 569px; color: rgb(0, 0, 0);"><h5 style="box-sizing: border-box; padding: 3px 0px 15px; margin: 0px 0px 25px; vertical-align: top; line-height: 1.2; border-bottom: 2px solid rgb(185, 185, 185); font-size: 20px; word-break: keep-all;">알기 쉬운 브라질 의료장비·의약품·화장품 인증</h5><ul class="report-info-list cf" style="box-sizing: border-box; padding: 0px; margin-top: 0px; margin-right: 0px; margin-bottom: 14px; vertical-align: top; line-height: 1.2; list-style: none;"><li style="box-sizing: border-box; padding: 0px 0px 0px 8px; margin: 0px 0px 11px; vertical-align: top; line-height: 1.2; list-style: none; float: left; width: 284.5px; position: relative; font-size: 15px;">작성자 : 이성훈 등</li><li style="box-sizing: border-box; padding: 0px 0px 0px 8px; margin: 0px 0px 11px; vertical-align: top; line-height: 1.2; list-style: none; float: left; width: 284px; position: relative; font-size: 15px;">총서번호 : GMR 16-055</li><li style="box-sizing: border-box; padding: 0px 0px 0px 8px; margin: 0px 0px 11px; vertical-align: top; line-height: 1.2; list-style: none; float: left; width: 284.5px; position: relative; font-size: 15px;">발간일 : 2016-12-15</li><li style="box-sizing: border-box; padding: 0px 0px 0px 8px; margin: 0px 0px 11px; vertical-align: top; line-height: 1.2; list-style: none; float: left; width: 284px; position: relative; font-size: 15px;">게재일 : 2016-12-15</li><li style="box-sizing: border-box; padding: 0px 0px 0px 8px; margin: 0px 0px 11px; vertical-align: top; line-height: 1.2; list-style: none; float: left; width: 284.5px; position: relative; font-size: 15px;">페이지 : 27</li><li style="box-sizing: border-box; padding: 0px 0px 0px 8px; margin: 0px 0px 11px; vertical-align: top; line-height: 1.2; list-style: none; float: left; width: 284px; position: relative; font-size: 15px;">게재자 : 이은혜</li><li class="width100" style="box-sizing: border-box; padding: 0px 0px 0px 8px; margin: 0px 0px 11px; vertical-align: top; line-height: 1.2; list-style: none; float: left; width: 569px; position: relative; font-size: 15px;">관련지역 : 중남미</li></ul><div class="btn-report-area" style="box-sizing: border-box; padding: 0px; margin: 44px 0px 0px; vertical-align: top; line-height: 1.2;"><ul class="cf" style="box-sizing: border-box; padding: 0px; margin-top: 0px; margin-right: 0px; margin-bottom: 0px; vertical-align: top; line-height: 1.2; list-style: none; display: inline-block;"><li style="box-sizing: border-box; padding: 0px; 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padding: 0px; margin: 0px; vertical-align: top; line-height: 1.2; list-style: none; float: left;"><a title="새창" class="btn-simple orange" style="box-sizing: border-box; padding: 0px; margin: 0px 10px 0px 0px; vertical-align: top; line-height: 33px; height: 33px; width: 145px; text-align: center; display: inline-block; background: rgb(232, 66, 0); color: rgb(255, 255, 255) !important;"><br></a></li></ul></div></div></div></div><p><br></p><p><br></p><p><br></p><p><br></p><p><br></p><p><br></p><p><br></p><p><br></p><p><br></p><p><br></p><p><br></p><p><br></p><p><br></p><p><br></p><p><br></p><p><br></p><p><br></p><p><br></p><p><br></p><p><br></p><p><br></p><p><br></p><p><br></p><p><br></p><p><br></p><p><br></p><p><br></p><p><br></p><p><br></p><p><br></p><p><br></p><div class="report-more-wrap" style="box-sizing: border-box; padding: 0px; margin: 0px 0px 30px; vertical-align: top; line-height: 1.2; position: relative; color: rgb(55, 55, 55); font-family: "Open Sans", "Nanum Gothic", 나눔고딕, NanumGothic, Arial, Helvetica, sans-serif; font-size: 14px;"><h6 style="box-sizing: border-box; padding: 0px 0px 10px 7px; margin: 0px; vertical-align: top; line-height: 1.2; font-size: 20px;">목차</h6><div class="report-more-box on" style="box-sizing: border-box; padding: 17px 22px; margin: 0px; vertical-align: top; line-height: 1.8; overflow: hidden; height: 597px; border-width: 2px 1px 1px; border-style: solid; border-color: rgb(185, 185, 185) rgb(213, 213, 213) rgb(213, 213, 213);"><p style="box-sizing: border-box; vertical-align: top; line-height: 2 !important;"></p><p style="box-sizing: border-box; vertical-align: top; line-height: 2 !important;">요 약 / 4</p><p style="box-sizing: border-box; vertical-align: top; line-height: 2 !important;"><br style="box-sizing: border-box; line-height: 2 !important;"></p><p style="box-sizing: border-box; vertical-align: top; line-height: 2 !important;">Ⅰ. 브라질 인증 발급기관 및 대상품목 / 5<br style="box-sizing: border-box; line-height: 2 !important;">1. 브라질 인증기관 현황<br style="box-sizing: border-box; line-height: 2 !important;">2. ANVISA 인증<br style="box-sizing: border-box; line-height: 2 !important;">3. 복합인증</p><p style="box-sizing: border-box; vertical-align: top; line-height: 2 !important;"><br style="box-sizing: border-box; line-height: 2 !important;"></p><p style="box-sizing: border-box; vertical-align: top; line-height: 2 !important;">Ⅱ. 인증 절차 / 9<br style="box-sizing: border-box; line-height: 2 !important;">1. ANVISA 인증 절차<br style="box-sizing: border-box; line-height: 2 !important;">2. 인증 취득 기간 및 비용</p><p style="box-sizing: border-box; vertical-align: top; line-height: 2 !important;"><br style="box-sizing: border-box; line-height: 2 !important;"></p><p style="box-sizing: border-box; vertical-align: top; line-height: 2 !important;">Ⅲ. 우리 기업의 ANVISA 인증 취득 사례 / 19<br style="box-sizing: border-box; line-height: 2 !important;">1. 의료장비 U사<br style="box-sizing: border-box; line-height: 2 !important;">2. 의약품 I사<br style="box-sizing: border-box; line-height: 2 !important;">3. 화장품 R사</p><p style="box-sizing: border-box; vertical-align: top; line-height: 2 !important;"><br style="box-sizing: border-box; line-height: 2 !important;"></p><p style="box-sizing: border-box; vertical-align: top; line-height: 2 !important;">Ⅳ. 제언 / 22<br style="box-sizing: border-box; line-height: 2 !important;">1. 제언</p><p style="box-sizing: border-box; vertical-align: top; line-height: 2 !important;"><br style="box-sizing: border-box; line-height: 2 !important;"></p><p style="box-sizing: border-box; vertical-align: top; line-height: 2 !important;">[첨부] 현지 컨설팅 기관</p><p style="box-sizing: border-box; vertical-align: top; line-height: 2 !important;"></p></div></div><p></p><div class="btn-bbs-area cf" style="box-sizing: border-box; padding: 0px 0px 10px; margin: 10px 0px 0px; vertical-align: top; line-height: 1.2; position: relative; color: rgb(55, 55, 55); font-family: "Open Sans", "Nanum Gothic", 나눔고딕, NanumGothic, Arial, Helvetica, sans-serif; font-size: 14px;"></div><p></p><div class="report-more-wrap" style="box-sizing: border-box; padding: 0px; margin: 0px 0px 30px; vertical-align: top; line-height: 1.2; position: relative; color: rgb(55, 55, 55); font-family: "Open Sans", "Nanum Gothic", 나눔고딕, NanumGothic, Arial, Helvetica, sans-serif; font-size: 14px; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: normal; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: rgb(255, 255, 255);"><h6 style="box-sizing: border-box; padding: 0px 0px 10px 7px; margin: 0px; vertical-align: top; line-height: 1.2; font-size: 20px;">요약</h6><div class="report-more-box" style="box-sizing: border-box; padding: 17px 22px; margin: 0px; vertical-align: top; line-height: 1.8; overflow: hidden; height: 185px; border-width: 2px 1px 1px; border-style: solid; border-color: rgb(185, 185, 185) rgb(213, 213, 213) rgb(213, 213, 213);"><p style="box-sizing: border-box; padding: 0px; margin: 0px; vertical-align: top; line-height: 2 !important; font-family: "Open Sans", "Nanum Gothic", 나눔고딕, NanumGothic, Arial, Helvetica, sans-serif !important; color: rgb(55, 55, 55) !important; font-size: 14px !important;"></p><p style="box-sizing: border-box; padding: 0px; margin: 0px; vertical-align: top; line-height: 2 !important; font-family: "Open Sans", "Nanum Gothic", 나눔고딕, NanumGothic, Arial, Helvetica, sans-serif !important; color: rgb(55, 55, 55) !important; font-size: 14px !important;">ㅇ 브라질에서는 인증을 받아야 수입·판매가 가능한 품목이 많으며 수입업체들이 많이 접촉하는 인증기관은 INMETRO(국가품질규격관리원), ANATEL(방송통신위원회), ANVISA(위생감시국) 등이 있음.</p><p style="box-sizing: border-box; padding: 0px; margin: 0px; vertical-align: top; line-height: 2 !important; font-family: "Open Sans", "Nanum Gothic", 나눔고딕, NanumGothic, Arial, Helvetica, sans-serif !important; color: rgb(55, 55, 55) !important; font-size: 14px !important;"><br style="box-sizing: border-box; font-family: "Open Sans", "Nanum Gothic", 나눔고딕, NanumGothic, Arial, Helvetica, sans-serif !important; color: rgb(55, 55, 55) !important; font-size: 14px !important; line-height: 2 !important;">ㅇ ANVISA는 국민의 위생, 건강과 관련된 모든 제품과 업체의 인허가·관리·감독 업무를 처리함.<br style="box-sizing: border-box; font-family: "Open Sans", "Nanum Gothic", 나눔고딕, NanumGothic, Arial, Helvetica, sans-serif !important; color: rgb(55, 55, 55) !important; font-size: 14px !important; line-height: 2 !important;">ㅇ ANVISA 인증이 필요한 분야는 의료(의료장비, 의약품), 건강 및 미용 제품(건강보조식품), 식품, 화장품, 담배 등이며, 이들 품목은 ANVISA 인증을 취득하지 않으면 브라질 내 유통과 판매가 기본적으로 불가능함.</p><p style="box-sizing: border-box; padding: 0px; margin: 0px; vertical-align: top; line-height: 2 !important; font-family: "Open Sans", "Nanum Gothic", 나눔고딕, NanumGothic, Arial, Helvetica, sans-serif !important; color: rgb(55, 55, 55) !important; font-size: 14px !important;"><br style="box-sizing: border-box; font-family: "Open Sans", "Nanum Gothic", 나눔고딕, NanumGothic, Arial, Helvetica, sans-serif !important; color: rgb(55, 55, 55) !important; font-size: 14px !important; line-height: 2 !important;">ㅇ 의료장비는 대부분 복합인증을 필요로 하는데, ANIVSA 인증과 함께 INMETRO 인증을 동시에 취득해야 함.</p><p style="box-sizing: border-box; padding: 0px; margin: 0px; vertical-align: top; line-height: 2 !important; font-family: "Open Sans", "Nanum Gothic", 나눔고딕, NanumGothic, Arial, Helvetica, sans-serif !important; color: rgb(55, 55, 55) !important; font-size: 14px !important;"><br style="box-sizing: border-box; font-family: "Open Sans", "Nanum Gothic", 나눔고딕, NanumGothic, Arial, Helvetica, sans-serif !important; color: rgb(55, 55, 55) !important; font-size: 14px !important; line-height: 2 !important;">ㅇ ANVISA 인증은 사업자등록증(CNPJ)을 보유한 현지 업체가 아니면 취득 불가능하므로 외국 기업은 현지법인 설립 후<br style="box-sizing: border-box; font-family: "Open Sans", "Nanum Gothic", 나눔고딕, NanumGothic, Arial, Helvetica, sans-serif !important; color: rgb(55, 55, 55) !important; font-size: 14px !important; line-height: 2 !important;">ANVISA에 등록하거나 현지 법정대리인(수입업체 등)을 통해야 취득이 가능함.</p><p style="box-sizing: border-box; padding: 0px; margin: 0px; vertical-align: top; line-height: 2 !important; font-family: "Open Sans", "Nanum Gothic", 나눔고딕, NanumGothic, Arial, Helvetica, sans-serif !important; color: rgb(55, 55, 55) !important; font-size: 14px !important;"><br style="box-sizing: border-box; font-family: "Open Sans", "Nanum Gothic", 나눔고딕, NanumGothic, Arial, Helvetica, sans-serif !important; color: rgb(55, 55, 55) !important; font-size: 14px !important; line-height: 2 !important;">ㅇ ANVISA 인증은 BRH 결정 후 ANVISA 시스템 등록 → BRH의 영업면허(AF) 및 영업허가(AFE) 취득 → 위험도 분류 →<br style="box-sizing: border-box; font-family: "Open Sans", "Nanum Gothic", 나눔고딕, NanumGothic, Arial, Helvetica, sans-serif !important; color: rgb(55, 55, 55) !important; font-size: 14px !important; line-height: 2 !important;">정식등록·약식등록 구분 → GMP 인증서인 CBPF 취득 → 필수서류 제출 → 최종발표등의순서로진행됨.</p><p style="box-sizing: border-box; padding: 0px; margin: 0px; vertical-align: top; line-height: 2 !important; font-family: "Open Sans", "Nanum Gothic", 나눔고딕, NanumGothic, Arial, Helvetica, sans-serif !important; color: rgb(55, 55, 55) !important; font-size: 14px !important;"><br style="box-sizing: border-box; font-family: "Open Sans", "Nanum Gothic", 나눔고딕, NanumGothic, Arial, Helvetica, sans-serif !important; color: rgb(55, 55, 55) !important; font-size: 14px !important; line-height: 2 !important;">ㅇ 인증 취득에 소요되는 기간 및 비용은 제품에 따라 다른데 6개월에서 2~3년 이상 걸리는 경우도 있고, 비용도 수 천<br style="box-sizing: border-box; font-family: "Open Sans", "Nanum Gothic", 나눔고딕, NanumGothic, Arial, Helvetica, sans-serif !important; color: rgb(55, 55, 55) !important; font-size: 14px !important; line-height: 2 !important;">헤알에서 수 만 헤알까지 큰 차이가 있음.</p><p style="box-sizing: border-box; padding: 0px; margin: 0px; vertical-align: top; line-height: 2 !important; font-family: "Open Sans", "Nanum Gothic", 나눔고딕, NanumGothic, Arial, Helvetica, sans-serif !important; color: rgb(55, 55, 55) !important; font-size: 14px !important;"></p></div><button type="button" class="more" style="box-sizing: border-box; padding: 0px 20px 0px 0px; margin: 0px; vertical-align: top; line-height: 1.2; font-size: 14px; font-family: "Open Sans", "Nanum Gothic", 나눔고딕, NanumGothic, Arial, Helvetica, sans-serif; background: url("/site/kotranews/images/sub/btn-report-more.gif") right center no-repeat; border: 0px; cursor: pointer; position: absolute; right: 7px; top: 5px;">더보기</button></div><p><br></p>