1.0Registrarhttps://legacy.registrarcorp.com/zh/Mason Granduskyhttps://legacy.registrarcorp.com/zh/author/mgrandusky/FDA UDI and GUDID Compliance Solutionsrich600338<blockquote class="wp-embedded-content" data-secret="1nV1oiFNr9"><a href="https://legacy.registrarcorp.com/zh/fda-medical-devices/udi/">FDA UDI and GUDID Compliance Solutions</a></blockquote><iframe sandbox="allow-scripts" security="restricted" src="https://legacy.registrarcorp.com/zh/fda-medical-devices/udi/embed/#?secret=1nV1oiFNr9" width="600" height="338" title="“FDA UDI and GUDID Compliance Solutions” — Registrar" data-secret="1nV1oiFNr9" frameborder="0" marginwidth="0" marginheight="0" scrolling="no" class="wp-embedded-content"></iframe><script type="text/javascript">
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https://legacy.registrarcorp.com/wp-content/uploads/2019/08/press_release.jpg1650500[vc_section el_id=”deadlineBar”][vc_row][vc_column offset=”vc_col-lg-offset-1 vc_col-lg-6 vc_col-md-6 vc_col-xs-12″][vc_raw_html]JTNDaDMlM0VJJUU3JUIxJUJCJUU1JThDJUJCJUU3JTk2JTk3JUU1JTk5JUE4JUU2JUEyJUIwJUU3JTlBJTg0VURJJUU1JTkwJTg4JUU4JUE3JTg0JUU2JTlDJTlGJUU5JTk5JTkwJUU1JUIwJTg2JUU1JUIwJTg2JUU4JTg3JUIzJTNDJTJGaDMlM0U=[/vc_raw_html][/vc_column][vc_column offset=”vc_col-lg-4 vc_col-md-6 vc_col-xs-12″][vc_row_inner][vc_column_inner width=”1/5″ offset=”vc_col-xs-1/5″][vc_raw_html]JTNDZGl2JTIwY2xhc3MlM0QlMjJjb3VudGRvd24tYmxvY2slMjIlM0UlMEElM0NkaXYlMjBpZCUzRCUyMmNvdW50ZG93bi13ZWVrcyUyMiUyMGNsYXNzJTNEJTIyY291bnRkb3duLW51bSUyMiUzRSUzQyUyRmRpdiUzRSUwQSUzQ3AlM0UlRTUlOTElQTglM0MlMkZwJTNFJTBBJTBBJTNDJTJGZGl2JTNF[/vc_raw_html][/vc_column_inner][vc_column_inner width=”1/5″ offset=”vc_col-xs-1/5″][vc_raw_html]JTNDZGl2JTIwY2xhc3MlM0QlMjJjb3VudGRvd24tYmxvY2slMjIlM0UlMEElM0NkaXYlMjBpZCUzRCUyMmNvdW50ZG93bi1kYXlzJTIyJTIwY2xhc3MlM0QlMjJjb3VudGRvd24tbnVtJTIyJTNFJTNDJTJGZGl2JTNFJTBBJTNDcCUzRSVFNSVBNCVBOSUzQyUyRnAlM0UlMEElMEElM0MlMkZkaXYlM0U=[/vc_raw_html][/vc_column_inner][vc_column_inner width=”1/5″ offset=”vc_col-xs-1/5″][vc_raw_html]JTNDZGl2JTIwY2xhc3MlM0QlMjJjb3VudGRvd24tYmxvY2slMjIlM0UlMEElM0NkaXYlMjBpZCUzRCUyMmNvdW50ZG93bi1ob3VycyUyMiUyMGNsYXNzJTNEJTIyY291bnRkb3duLW51bSUyMiUzRSUzQyUyRmRpdiUzRSUwQSUzQ3AlM0UlRTUlQjAlOEYlRTYlOTclQjYlM0MlMkZwJTNFJTBBJTBBJTNDJTJGZGl2JTNF[/vc_raw_html][/vc_column_inner][vc_column_inner width=”1/5″ offset=”vc_col-xs-1/5″][vc_raw_html]JTNDZGl2JTIwY2xhc3MlM0QlMjJjb3VudGRvd24tYmxvY2slMjIlM0UlMEElM0NkaXYlMjBpZCUzRCUyMmNvdW50ZG93bi1taW4lMjIlMjBjbGFzcyUzRCUyMmNvdW50ZG93bi1udW0lMjIlM0UlM0MlMkZkaXYlM0UlMEElM0NwJTNFJUU1JTg4JTg2JTNDJTJGcCUzRSUwQSUwQSUzQyUyRmRpdiUzRQ==[/vc_raw_html][/vc_column_inner][vc_column_inner width=”1/5″ offset=”vc_col-xs-1/5″][vc_raw_html]JTNDZGl2JTIwY2xhc3MlM0QlMjJjb3VudGRvd24tYmxvY2slMjIlM0UlMEElM0NkaXYlMjBpZCUzRCUyMmNvdW50ZG93bi1zZWNvbmRzJTIyJTIwY2xhc3MlM0QlMjJjb3VudGRvd24tbnVtJTIyJTNFJTNDJTJGZGl2JTNFJTBBJTNDcCUzRSVFNyVBNyU5MiUzQyUyRnAlM0UlMEElMEElM0MlMkZkaXYlM0U=[/vc_raw_html][/vc_column_inner][/vc_row_inner][/vc_column][/vc_row][/vc_section][vc_section el_id=”sectionHero”][vc_row][vc_column offset=”vc_col-lg-6 vc_col-md-6″][vc_row_inner el_class=”tile-box”][vc_column_inner][vc_column_text] FDA UDI和GUDID合规方案 根据FDA的唯一医疗器械标识符(UDI)规则，大多数医疗器械的标签和包装必须包含UDI。产品的品牌持有人必须申请UDI并且将产品信息，包括产品识别码（DI），产品代码，以及其他特征上传至全球唯一器械识别码数据库（GUDID） 大多数医疗器械的UDI合规期限已过[/vc_column_text][/vc_column_inner][/vc_row_inner][/vc_column][vc_column el_id=”form-box” offset=”vc_col-lg-offset-2 vc_col-lg-4 vc_col-md-6″][vc_row_inner el_class=”form-box floating-box”][vc_column_inner][vc_column_text] 获取专家协助 Registrar Corp的法规专家可以协助贵司遵循FDA的UDI和GUDID要求。[/vc_column_text][vc_raw_html]JTVCZ3Jhdml0eWZvcm0lMjBpZCUzRCUyMjMlMjIlMjB0aXRsZSUzRCUyMmZhbHNlJTIyJTIwZGVzY3JpcHRpb24lM0QlMjJmYWxzZSUyMiUyMGFqYXglM0QlMjJ0cnVlJTIyJTIwZmllbGRfdmFsdWVzJTNEJTIyaW5xdWlyeV90eXBlJTNEVURJJTIwYW5kJTIwR1VESUQlMjZmb3JtX3R5cGUlM0RzaG9ydCUyMiU1RA==[/vc_raw_html][/vc_column_inner][/vc_row_inner][/vc_column][/vc_row][/vc_section][vc_section el_id=”udiBreakdown”][vc_row][vc_column offset=”vc_col-lg-8″][vc_row_inner][vc_column_inner][vc_column_text] UDI是什么？ UDI是指一串识别某个医疗器械品牌持有人的某个医疗器械的人眼及机器可读的编码。括号中的数字限定了后面跟随的数字或者字母与数字结合的代码的具体指代意义。[/vc_column_text][/vc_column_inner][/vc_row_inner][vc_row_inner][vc_column_inner css=”.vc_custom_1584728412057{margin-top: 40px !important;margin-bottom: 40px !important;}”][vc_single_image image=”42873″ img_size=”full” alignment=”center”][/vc_column_inner][vc_column_inner css=”.vc_custom_1584726429191{margin-bottom: 30px !important;}”][vc_column_text css=”.vc_custom_1585324502391{margin-bottom: 10px !important;}”] UDI由两个主要元素组成：