제3차 美FDA 의료기기 UDI 규정 대응방안 세미나 // 대한상공회의소 국제표준팀

<section class="board-view-head" style="border-top-width: 2px; border-top-style: solid; border-top-color: rgb(17, 17, 17); border-bottom-width: 1px; border-bottom-style: solid; border-bottom-color: rgb(170, 170, 170); color: rgb(51, 51, 51); font-family: "Nanum Gothic"; font-size: 16px; font-weight: bold; line-height: 22.4px;"><div class="tit" style="margin: 0px; padding: 9px 100px 9px 10px; border-width: 0px 0px 1px; border-bottom-style: solid; border-bottom-color: rgb(236, 236, 236); vertical-align: baseline; position: relative; height: 22px; background: transparent;"><h4 style="margin: 0px; padding: 0px; border: 0px; vertical-align: baseline; line-height: 22px; float: left; background: transparent;">제3차 美FDA 의료기기 UDI 규정 대응방안 세미나</h4><p class="date" style="margin-right: 10px; padding-left: 21px; border: 0px; vertical-align: baseline; position: absolute; display: inline-block; font-size: 13px; line-height: 22px; font-weight: normal; top: 9px; right: 0px; background: transparent;"><span class="icon clock" style="margin: -9px 0px 0px; padding: 0px; border: 0px; vertical-align: middle; text-indent: -9999px; font-size: 0px; line-height: 0; display: inline-block; width: 16px; height: 16px; position: absolute; left: 0px; top: 11px; background: url("../imgs/sprite.png?v=14") -29px -30px no-repeat;">2016.08.26</div><div class="info" style="margin: 0px; padding: 9px 10px; border: 0px; vertical-align: baseline; overflow: hidden; background: transparent;"><ul class="file" style="margin-top: 0px; margin-right: 0px; margin-bottom: 0px; padding: 0px; border: 0px; vertical-align: baseline; list-style: none; float: left; max-width: 500px; width: auto !important; background: transparent;"><li style="margin: 0px; padding: 0px; border: 0px; vertical-align: baseline; list-style: none; float: left; width: 90px; line-height: 22px; font-size: 14px; color: rgb(118, 118, 118); background: transparent;"><span class="icon download" style="margin: 0px 0px 4px; padding: 0px; border: 0px; vertical-align: middle; text-indent: -9999px; font-size: 0px; line-height: 0; display: inline-block; width: 9px; height: 11px; background: url("../imgs/sprite.png?v=14") -11px -127px no-repeat;"> 첨부파일</li><li style="margin: 0px; padding: 0px; border: 0px; vertical-align: baseline; list-style: none; float: left; width: 410px; line-height: 22px; font-size: 14px; color: rgb(118, 118, 118); background: transparent;">첨부파일이 없습니다.</li></ul><span class="icon bcircle" style="margin: 0px 0px 4px; padding: 0px; border: 0px; vertical-align: middle; text-indent: -9999px; font-size: 0px; line-height: 0; display: inline-block; width: 9px; height: 9px; background: url("../imgs/sprite.png?v=14") -28px -127px no-repeat;"> 담당부서 국제표준팀<ul class="file" style="margin-top: 0px; margin-right: 0px; margin-bottom: 0px; padding: 0px; border: 0px; vertical-align: baseline; list-style: none; float: left; max-width: 500px; width: auto !important; background: transparent;"></ul><span class="icon bcircle" style="margin: 0px 0px 4px; padding: 0px; border: 0px; vertical-align: middle; text-indent: -9999px; font-size: 0px; line-height: 0; display: inline-block; width: 9px; height: 9px; background: url("../imgs/sprite.png?v=14") -28px -127px no-repeat;"> 참가신청 <a style="margin: 0px; padding: 0px; border: 0px; vertical-align: baseline; color: inherit; background: transparent;"><span class="tag blue" style="margin: 0px; padding: 0px; border: 0px; vertical-align: middle; display: inline-block; color: rgb(255, 255, 255); width: 76px; height: 21px; line-height: 21px; font-size: 12px; text-align: center; background: rgb(7, 140, 225);">신청</a> <a style="margin: 0px; padding: 0px; border: 0px; vertical-align: baseline; color: inherit; background: transparent;"><span class="tag orange" style="margin: 0px; padding: 0px; border: 0px; vertical-align: middle; display: inline-block; color: rgb(255, 255, 255); width: 76px; height: 21px; line-height: 21px; font-size: 12px; text-align: center; background: rgb(239, 90, 0);">신청확인</a></div></section><section class="board-view" style="padding: 20px 10px; font-size: 14px; line-height: 24px; color: rgb(0, 0, 0); font-family: "Nanum Gothic";"><table style="margin: 0px; padding: 0px; border: 0px; vertical-align: baseline; border-collapse: collapse; border-spacing: 0px; width: 800px; background: transparent;"><tbody style="margin: 0px; padding: 0px; border: 0px; vertical-align: baseline; background: transparent;"><tr style="margin: 0px; padding: 0px; border: 0px; vertical-align: baseline; background: transparent;"><td class="view_td_cont" colspan="4" style="margin: 0px; padding: 0px; border: 0px; vertical-align: middle; background: transparent;"><div id="div_view_result" style="margin: 0px; padding: 0px 0px 0px 15px; border: 0px; vertical-align: baseline; background: transparent;"><div id="dext_body" spellcheck="false" style="margin: 0px; padding: 0px; border: 0px; vertical-align: baseline; background: transparent;"> 美FDA Class II 전체 의료기기 대상 UDI* Regulation 관련 입니다.* Unique Device Identification : 의료기기 고유식별      GS1  표준을 이용한 UDI 규정 대응방안을 논의 하는 "제3차 美FDA UDI 규정 대응방안 세미나" 를 다음과 같이 개최하오니 의료기기수출기업 관계자 분들의 참여 바랍니다 .                 - 다                      음 -             1. 일     시 :     8. 26(금) 14:00 ~ 18:00        2. 장     소 :     대한상공회의소 의원회의실     (서울 중구 세종대로 39, 상공회의소 지하2층)      3. 참석대상 :   유통표준코드회원사 Only        (GS1 표준 사용자)      4. 참 가 비 :    무료      5. 프로그램(안)           <table border="0" cellspacing="0" cellpadding="0" style="margin: 0px; padding: 0px; border: 0px; vertical-align: baseline; border-collapse: collapse; border-spacing: 0px; width: 637px; background: transparent;"><colgroup><col width="117" style="width: 117px;"><col width="344" style="width: 344px;"><col width="176" style="width: 176px;"></colgroup><tbody style="margin: 0px; padding: 0px; border: 0px; vertical-align: baseline; background: transparent;"><tr style="margin: 0px; padding: 0px; border: 0px; vertical-align: baseline; background: transparent;"><td width="117" height="26" class="xl65" style="margin: 0px; padding: 0px; border: 1px solid gray; vertical-align: middle; width: 117px; height: 27px; background: rgb(112, 173, 71);">시간</td><td width="344" class="xl65" style="margin: 0px; padding: 0px; border-width: 1px 1px 1px 0px; border-style: solid solid solid none; border-color: gray gray gray white; vertical-align: middle; width: 344px; background: rgb(112, 173, 71);">주요내용</td><td width="176" class="xl65" style="margin: 0px; padding: 0px; border-width: 1px 1px 1px 0px; border-style: solid solid solid none; border-color: gray gray gray white; vertical-align: middle; width: 176px; background: rgb(112, 173, 71);">비고  </td></tr><tr style="margin: 0px; padding: 0px; border: 0px; vertical-align: baseline; background: transparent;"><td height="26" class="xl66" style="margin: 0px; padding: 0px; border-width: 0px 1px 1px; border-style: none solid solid; border-color: black gray gray; vertical-align: middle; height: 38.42px; background: transparent;">14:00~14:30</td><td class="xl68" style="margin: 0px; padding: 0px; border-width: 0px 1px 1px 0px; border-style: none solid solid none; border-color: black gray gray black; vertical-align: middle; height: 38.42px; background: transparent;">  UDI 개요 및 글로벌 동향</td><td class="xl66" style="margin: 0px; padding: 0px; border-width: 0px 1px 1px 0px; border-style: none solid solid none; border-color: black gray gray black; vertical-align: middle; height: 38.42px; background: transparent;"></td></tr><tr style="margin: 0px; padding: 0px; border: 0px; vertical-align: baseline; background: transparent;"><td height="54" class="xl70" style="margin: 0px; padding: 0px; border-width: 0px 1px; border-style: none solid; border-color: black gray; vertical-align: middle; height: 59.71px; background: transparent;">14:30~15:00</td><td width="344" class="xl69" style="margin: 0px; padding: 0px; border-width: 0px 1px 1px 0px; border-style: none solid solid none; border-color: black gray gray black; vertical-align: middle; width: 344px; height: 59.71px; background: transparent;">  최근 FDA UDI 규정 Updates       - Form and Content of the UDI</td><td class="xl66" style="margin: 0px; padding: 0px; border-width: 0px 1px 1px 0px; border-style: none solid solid none; border-color: black gray gray black; vertical-align: middle; height: 59.7px; background: transparent;">16년 7월 26일 현재</td></tr><tr style="margin: 0px; padding: 0px; border: 0px; vertical-align: baseline; background: transparent;"><td height="153" class="xl70" style="margin: 0px; padding: 0px; border-width: 1px 1px 0px; border-style: solid solid none; border-color: gray gray black; vertical-align: middle; height: 153px; background: transparent;">15:00~16:00</td><td width="344" class="xl69" style="margin: 0px; padding: 0px; border-width: 0px 1px 1px 0px; border-style: none solid solid none; border-color: black gray gray black; vertical-align: middle; width: 344px; background: transparent;">  의료기기산업 GS1 표준            - DI 생성기준 (GTIN Allocation Rules)        - PI 입력방법 (GS1 Application Identifier)      - UDI 바코드 (GS1 Data Carriers)      - 바코드 검증 (Barcode Verification)        - 기타 중요사항 (GS1 Function Code 1 등) </td><td class="xl67" style="margin: 0px; padding: 0px; border-width: 0px 1px 1px 0px; border-style: none solid solid none; border-color: black gray gray black; vertical-align: middle; background: transparent;"> </td></tr><tr style="margin: 0px; padding: 0px; border: 0px; vertical-align: baseline; background: transparent;"><td height="82" class="xl70" style="margin: 0px; padding: 0px; border-width: 1px 1px 0px; border-style: solid solid none; border-color: gray gray black; vertical-align: middle; height: 82px; background: transparent;">16:00~17:30</td><td width="344" class="xl69" style="margin: 0px; padding: 0px; border-width: 0px 1px 1px 0px; border-style: none solid solid none; border-color: black gray gray black; vertical-align: middle; width: 344px; background: transparent;">  GS1 UDI Implementation Guideline            - UDI 라벨링 방안 (GS1 UDI Labeling)        - 직접인쇄 (Direct Marking)  </td><td class="xl67" style="margin: 0px; padding: 0px; border-width: 0px 1px 1px 0px; border-style: none solid solid none; border-color: black gray gray black; vertical-align: middle; background: transparent;">     </td></tr><tr style="margin: 0px; padding: 0px; border: 0px; vertical-align: baseline; background: transparent;"><td height="26" class="xl66" style="margin: 0px; padding: 0px; border: 1px solid gray; vertical-align: middle; height: 35.57px; background: transparent;">17:30~18:00</td><td class="xl68" style="margin: 0px; padding: 0px; border-width: 0px 1px 1px 0px; border-style: none solid solid none; border-color: black gray gray black; vertical-align: middle; height: 35.57px; background: transparent;">  Q&A</td><td class="xl67" style="margin: 0px; padding: 0px; border-width: 0px 1px 1px 0px; border-style: none solid solid none; border-color: black gray gray black; vertical-align: middle; height: 35.56px; background: transparent;"> </td></tr></tbody></table>  6. 참가신청 :    유통표준코드회원사  1社당 4인까지 신청 가능 (선착순 100명 모집)        * 신청방법 :   동 웹페이지 내 우측상단, 참가신청 "        <span style="margin: 0px; padding: 0px; border: 0px; vertical-align: baseline; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">신청      " 클릭       7. 문의 : 국제표준팀 (Tel: 02-6050-1504, email to   <a href="mailto:srlee@korcham.net" style="margin: 0px; padding: 0px; border: 0px; vertical-align: baseline; color: inherit; background: transparent;">srlee@korcham.net </a>)</div></div></td></tr></tbody></table></section>