의료기기 표준코드 의무화, 올해 7월 1일부터 본격 시행

<table style="border: 0.28pt solid rgb(0, 0, 0); border-collapse: collapse; mso-table-overlap: never;"><tbody><tr><td valign="center" style="background: rgb(204, 255, 102); padding: 1.41pt; border: 0.56pt solid rgb(0, 0, 0); width: 64.39pt; height: 29.14pt;">첨부1</td><td valign="center" style="border-width: medium 0.56pt; border-style: none solid; border-color: currentColor rgb(0, 0, 0); padding: 1.41pt; width: 8.48pt; height: 29.14pt;">   </td><td valign="center" style="padding: 1.41pt; border: 0.56pt solid rgb(0, 0, 0); width: 406.82pt; height: 29.14pt;"> 표준코드 등 정보의 전산등록 계도(적응)기간 운영 안내</td></tr></tbody></table> <img width="13" height="14" src="data:image/png;base64,R0lGODlhEwATAPIAAAAAAAMDAxAQECgoKDAwMP///wAAAAAAACH5BAAAAAUALAAAAAATABMAAAM+SLDcTSWCSKud0mq6IN7XMH0gJxZkiZ5pCbBq9Y6xSdfrXc8onvc4Xgsk9PEEjiQjcJIMntBo9INUJgU+TQIAOw==" v:shapes="_x187933040"> 취급자 ‘전산등록’ 계도(적응)기간 운영 ❍「의료기기법」제31조의3에 따른 「의료기기 표준코드 부착 및 통합정보시스템 등록」제도가 2019년 7월 1일부터 시행됩니다. - 따라서 의료기기 제조·수입업자는 7월 1일 이후 제조·수입하는 의료기기에 대해 표준코드를 생성·부착하여야하며, 의료기기통합정보시스템에 등록하여야 합니다. * 통합정보시스템 정식 오픈은 6월 24일이며, 정식 오픈 이후 표준코드 등의 정보 등록 가능 ❍ 시행 후, 2019년 9월 30일까지는 다음과 같이 취급자(업체)를 위해 의료기기 통합정보시스템 계도(적응)기간으로 운영합니다. - 통합정보시스템에 등록함에 있어 정보의 일부를 누락하거나 착오 등으로 잘못 보고를 하더라도 행정처분을 하지 않고 시정하도록 합니다. - 다만, 해당 업체가 취급하는 제품 전부의 표준코드 등의 정보를 전산에 정보를 등록하지 않는 경우 또는 부정한 목적으로 거짓 정보를 부착·등록하는 경우에는 행정처분의 대상이 됩니다.   <table style="border: 0.28pt solid rgb(0, 0, 0); border-collapse: collapse; mso-table-overlap: never;"><tbody><tr><td valign="center" style="background: rgb(19, 42, 67); border-width: medium medium 0.28pt; border-style: none none solid; border-color: currentColor currentColor rgb(0, 0, 0); padding: 1.41pt 5.1pt; width: 170.06pt; height: 27.14pt;">‘계도(적응)기간’의 의미</td><td valign="center" style="border-width: medium medium 0.28pt; border-style: none none solid; border-color: currentColor currentColor rgb(0, 0, 0); padding: 1.41pt 5.1pt; width: 130.44pt; height: 27.14pt;">   </td><td valign="center" style="border-width: medium medium 0.28pt; border-style: none none solid; border-color: currentColor currentColor rgb(0, 0, 0); padding: 1.41pt 5.1pt; width: 167.23pt; height: 27.14pt;">   </td></tr><tr><td valign="center" style="padding: 1.41pt 5.1pt; border: 0.28pt solid rgb(0, 0, 0); width: 467.73pt; height: 130.31pt;" colspan="3">✔ 계도(적응)기간 일지라도 의료기기 제조·수입업자는 제조·수입하는 의료기기에 대해 표준코드를 부착하여야하며, 의료기기통합정보시스템에 전산등록 하여야 합니다.✔ 다만, 착오로 인한 비의도적인 실수, 컴퓨터 및 네트워크 장애로 인한 등록누락, 잘못된 입력으로 인한 일부 정보 누락 등에 대해 행정처분을 하지 않고 정정할 기회를 제공하는 것을 의미합니다.</td></tr></tbody></table><table style="border: 0.28pt solid rgb(0, 0, 0); border-collapse: collapse; mso-table-overlap: never;"><tbody><tr><td valign="center" style="background: rgb(204, 255, 102); padding: 1.41pt; border: 0.56pt solid rgb(0, 0, 0); width: 64.39pt; height: 29.14pt;">첨부2</td><td valign="center" style="border-width: medium 0.56pt; border-style: none solid; border-color: currentColor rgb(0, 0, 0); padding: 1.41pt; width: 8.48pt; height: 29.14pt;">   </td><td valign="center" style="padding: 1.41pt; border: 0.56pt solid rgb(0, 0, 0); width: 406.82pt; height: 29.14pt;"> 의료기기 통합정보 등록 시스템 사용자 교육 계획</td></tr></tbody></table><p class="0" style="text-align: right; text-indent: -36.1pt; margin-top: 5pt; margin-left: 36.1pt; -ms-text-autospace:; -ms-word-break: keep-all; mso-pagination: none; mso-padding-alt: 0.0pt 0.0pt 0.0pt 0.0pt;">    <img width="13" height="14" src="data:image/png;base64,R0lGODlhEwATAPIAAAAAAAMDAxAQECgoKDAwMP///wAAAAAAACH5BAAAAAUALAAAAAATABMAAAM+SLDcTSWCSKud0mq6IN7XMH0gJxZkiZ5pCbBq9Y6xSdfrXc8onvc4Xgsk9PEEjiQjcJIMntBo9INUJgU+TQIAOw==" v:shapes="_x188323608"> 교육 대상 ❍ 4등급 의료기기 제조‧수입업체    <img width="13" height="14" src="data:image/png;base64,R0lGODlhEwATAPIAAAAAAAMDAxAQECgoKDAwMP///wAAAAAAACH5BAAAAAUALAAAAAATABMAAAM+SLDcTSWCSKud0mq6IN7XMH0gJxZkiZ5pCbBq9Y6xSdfrXc8onvc4Xgsk9PEEjiQjcJIMntBo9INUJgU+TQIAOw==" v:shapes="_x188342248"> 교육 일시 및 장소<table style="border: 0.28pt solid rgb(0, 0, 0); border-collapse: collapse; mso-table-overlap: never;"><tbody><tr><td valign="center" style="background: rgb(191, 191, 233); padding: 1.41pt 5.1pt; border: 0.28pt solid rgb(0, 0, 0); width: 124.72pt; height: 23.48pt;">일 시</td><td valign="center" style="background: rgb(191, 191, 233); padding: 1.41pt 5.1pt; border: 0.28pt solid rgb(0, 0, 0); width: 53.97pt; height: 23.48pt;">지역</td><td valign="center" style="background: rgb(191, 191, 233); padding: 1.41pt 5.1pt; border: 0.28pt solid rgb(0, 0, 0); width: 223.77pt; height: 23.48pt;">장 소</td><td valign="center" style="background: rgb(191, 191, 233); padding: 1.41pt 5.1pt; border: 0.28pt solid rgb(0, 0, 0); width: 73.78pt; height: 23.48pt;">수용인원</td></tr><tr><td valign="center" style="padding: 1.41pt 5.1pt; border: 0.28pt solid rgb(0, 0, 0); width: 124.72pt; height: 86pt;" rowspan="2"><p class="0" style="text-align: center; line-height: 130%; text-indent: -30.3pt; margin-left: 30.3pt; -ms-text-autospace:; -ms-word-break: keep-all; mso-pagination: none; mso-padding-alt: 0.0pt 0.0pt 0.0pt 0.0pt;">2019.6.17.(월)<p class="0" style="text-align: center; line-height: 130%; text-indent: -30.3pt; margin-left: 30.3pt; -ms-text-autospace:; -ms-word-break: keep-all; mso-pagination: none; mso-padding-alt: 0.0pt 0.0pt 0.0pt 0.0pt;">14:00~16:30</td><td valign="center" style="padding: 1.41pt 5.1pt; border: 0.28pt solid rgb(0, 0, 0); width: 53.97pt; height: 43pt;"><p class="0" style="text-align: center; line-height: 130%; text-indent: -30.3pt; margin-left: 30.3pt; -ms-text-autospace:; -ms-word-break: keep-all; mso-pagination: none; mso-padding-alt: 0.0pt 0.0pt 0.0pt 0.0pt;">부산</td><td valign="center" style="padding: 1.41pt 5.1pt; border: 0.28pt solid rgb(0, 0, 0); width: 223.77pt; height: 43pt;">부산지방식품의약품안전청 행정동 14층 강당</td><td valign="center" style="padding: 1.41pt 5.1pt; border: 0.28pt solid rgb(0, 0, 0); width: 73.78pt; height: 43pt;"><p class="0" style="text-align: center; line-height: 130%; text-indent: -30.3pt; margin-left: 30.3pt; -ms-text-autospace:; -ms-word-break: keep-all; mso-pagination: none; mso-padding-alt: 0.0pt 0.0pt 0.0pt 0.0pt;">50명</td></tr><tr><td valign="center" style="padding: 1.41pt 5.1pt; border: 0.28pt solid rgb(0, 0, 0); width: 53.97pt; height: 43pt;"><p class="0" style="text-align: center; line-height: 130%; text-indent: -30.3pt; margin-left: 30.3pt; -ms-text-autospace:; -ms-word-break: keep-all; mso-pagination: none; mso-padding-alt: 0.0pt 0.0pt 0.0pt 0.0pt;">대구</td><td valign="center" style="padding: 1.41pt 5.1pt; border: 0.28pt solid rgb(0, 0, 0); width: 223.77pt; height: 43pt;">대구지방식품의약품안전청 1층 강당</td><td valign="center" style="padding: 1.41pt 5.1pt; border: 0.28pt solid rgb(0, 0, 0); width: 73.78pt; height: 43pt;"><p class="0" style="text-align: center; line-height: 130%; text-indent: -30.3pt; margin-left: 30.3pt; -ms-text-autospace:; -ms-word-break: keep-all; mso-pagination: none; mso-padding-alt: 0.0pt 0.0pt 0.0pt 0.0pt;">75명</td></tr><tr><td valign="center" style="padding: 1.41pt 5.1pt; border: 0.28pt solid rgb(0, 0, 0); width: 124.72pt; height: 86pt;" rowspan="2"><p class="0" style="text-align: center; line-height: 130%; text-indent: -30.3pt; margin-left: 30.3pt; -ms-text-autospace:; -ms-word-break: keep-all; mso-pagination: none; mso-padding-alt: 0.0pt 0.0pt 0.0pt 0.0pt;">2019.6.18.(화)<p class="0" style="text-align: center; line-height: 130%; text-indent: -30.3pt; margin-left: 30.3pt; -ms-text-autospace:; -ms-word-break: keep-all; mso-pagination: none; mso-padding-alt: 0.0pt 0.0pt 0.0pt 0.0pt;">14:00~16:30</td><td valign="center" style="padding: 1.41pt 5.1pt; border: 0.28pt solid rgb(0, 0, 0); width: 53.97pt; height: 43pt;"><p class="0" style="text-align: center; line-height: 130%; text-indent: -30.3pt; margin-left: 30.3pt; -ms-text-autospace:; -ms-word-break: keep-all; mso-pagination: none; mso-padding-alt: 0.0pt 0.0pt 0.0pt 0.0pt;">대전</td><td valign="center" style="padding: 1.41pt 5.1pt; border: 0.28pt solid rgb(0, 0, 0); width: 223.77pt; height: 43pt;">대전지방식품의약품안전청 1층 강당</td><td valign="center" style="padding: 1.41pt 5.1pt; border: 0.28pt solid rgb(0, 0, 0); width: 73.78pt; height: 43pt;"><p class="0" style="text-align: center; line-height: 130%; text-indent: -30.3pt; margin-left: 30.3pt; -ms-text-autospace:; -ms-word-break: keep-all; mso-pagination: none; mso-padding-alt: 0.0pt 0.0pt 0.0pt 0.0pt;">50명</td></tr><tr><td valign="center" style="padding: 1.41pt 5.1pt; border: 0.28pt solid rgb(0, 0, 0); width: 53.97pt; height: 43pt;"><p class="0" style="text-align: center; line-height: 130%; text-indent: -30.3pt; margin-left: 30.3pt; -ms-text-autospace:; -ms-word-break: keep-all; mso-pagination: none; mso-padding-alt: 0.0pt 0.0pt 0.0pt 0.0pt;">광주</td><td valign="center" style="padding: 1.41pt 5.1pt; border: 0.28pt solid rgb(0, 0, 0); width: 223.77pt; height: 43pt;">광주지방식품의약품안전청 1층 강당</td><td valign="center" style="padding: 1.41pt 5.1pt; border: 0.28pt solid rgb(0, 0, 0); width: 73.78pt; height: 43pt;"><p class="0" style="text-align: center; line-height: 130%; text-indent: -30.3pt; margin-left: 30.3pt; -ms-text-autospace:; -ms-word-break: keep-all; mso-pagination: none; mso-padding-alt: 0.0pt 0.0pt 0.0pt 0.0pt;">50명</td></tr><tr><td valign="center" style="padding: 1.41pt 5.1pt; border: 0.28pt solid rgb(0, 0, 0); width: 124.72pt; height: 62.52pt;"><p class="0" style="text-align: center; line-height: 130%; text-indent: -30.3pt; margin-left: 30.3pt; -ms-text-autospace:; -ms-word-break: keep-all; mso-pagination: none; mso-padding-alt: 0.0pt 0.0pt 0.0pt 0.0pt;">2019.6.19.(수)<p class="0" style="text-align: center; line-height: 130%; text-indent: -30.3pt; margin-left: 30.3pt; -ms-text-autospace:; -ms-word-break: keep-all; mso-pagination: none; mso-padding-alt: 0.0pt 0.0pt 0.0pt 0.0pt;">1차: 09:30~12:00<p class="0" style="text-align: center; line-height: 130%; text-indent: -30.3pt; margin-left: 30.3pt; -ms-text-autospace:; -ms-word-break: keep-all; mso-pagination: none; mso-padding-alt: 0.0pt 0.0pt 0.0pt 0.0pt;">2차: 14:00~16:30</td><td valign="center" style="padding: 1.41pt 5.1pt; border: 0.28pt solid rgb(0, 0, 0); width: 53.97pt; height: 62.52pt;"><p class="0" style="text-align: center; line-height: 130%; text-indent: -30.3pt; margin-left: 30.3pt; -ms-text-autospace:; -ms-word-break: keep-all; mso-pagination: none; mso-padding-alt: 0.0pt 0.0pt 0.0pt 0.0pt;">서울</td><td valign="center" style="padding: 1.41pt 5.1pt; border: 0.28pt solid rgb(0, 0, 0); width: 223.77pt; height: 62.52pt;">경기대학교 서울캠퍼스 본관 대강당 블랙홀(서울 서대문구 소재)</td><td valign="center" style="padding: 1.41pt 5.1pt; border: 0.28pt solid rgb(0, 0, 0); width: 73.78pt; height: 62.52pt;"><p class="0" style="text-align: center; line-height: 130%; text-indent: -30.3pt; margin-left: 30.3pt; -ms-text-autospace:; -ms-word-break: keep-all; mso-pagination: none; mso-padding-alt: 0.0pt 0.0pt 0.0pt 0.0pt;">200명<p class="0" style="text-align: center; line-height: 130%; text-indent: -30.3pt; margin-left: 30.3pt; -ms-text-autospace:; -ms-word-break: keep-all; mso-pagination: none; mso-padding-alt: 0.0pt 0.0pt 0.0pt 0.0pt;">(회당)</td></tr><tr><td valign="center" style="padding: 1.41pt 5.1pt; border: 0.28pt solid rgb(0, 0, 0); width: 124.72pt; height: 43pt;"><p class="0" style="text-align: center; line-height: 130%; text-indent: -30.3pt; margin-left: 30.3pt; -ms-text-autospace:; -ms-word-break: keep-all; mso-pagination: none; mso-padding-alt: 0.0pt 0.0pt 0.0pt 0.0pt;">2019.6.20.(목)<p class="0" style="text-align: center; line-height: 130%; text-indent: -30.3pt; margin-left: 30.3pt; -ms-text-autospace:; -ms-word-break: keep-all; mso-pagination: none; mso-padding-alt: 0.0pt 0.0pt 0.0pt 0.0pt;">14:00~16:30</td><td valign="center" style="padding: 1.41pt 5.1pt; border: 0.28pt solid rgb(0, 0, 0); width: 53.97pt; height: 43pt;"><p class="0" style="text-align: center; line-height: 130%; text-indent: -30.3pt; margin-left: 30.3pt; -ms-text-autospace:; -ms-word-break: keep-all; mso-pagination: none; mso-padding-alt: 0.0pt 0.0pt 0.0pt 0.0pt;">오송</td><td valign="center" style="padding: 1.41pt 5.1pt; border: 0.28pt solid rgb(0, 0, 0); width: 223.77pt; height: 43pt;">오송보건의료행정타운 후생관 대강당</td><td valign="center" style="padding: 1.41pt 5.1pt; border: 0.28pt solid rgb(0, 0, 0); width: 73.78pt; height: 43pt;"><p class="0" style="text-align: center; line-height: 130%; text-indent: -30.3pt; margin-left: 30.3pt; -ms-text-autospace:; -ms-word-break: keep-all; mso-pagination: none; mso-padding-alt: 0.0pt 0.0pt 0.0pt 0.0pt;">400명</td></tr></tbody></table>    <img width="13" height="14" src="data:image/png;base64,R0lGODlhEwATAPIAAAAAAAMDAxAQECgoKDAwMP///wAAAAAAACH5BAAAAAUALAAAAAATABMAAAM+SLDcTSWCSKud0mq6IN7XMH0gJxZkiZ5pCbBq9Y6xSdfrXc8onvc4Xgsk9PEEjiQjcJIMntBo9INUJgU+TQIAOw==" v:shapes="_x188459080"> 교육 내용<table style="border: 0.28pt solid rgb(0, 0, 0); border-collapse: collapse; mso-table-overlap: never;"><tbody><tr><td valign="center" style="background: rgb(191, 191, 233); padding: 1.41pt 5.1pt; border: 0.28pt solid rgb(0, 0, 0); width: 53.97pt; height: 26.31pt;">순번</td><td valign="center" style="background: rgb(191, 191, 233); padding: 1.41pt 5.1pt; border: 0.28pt solid rgb(0, 0, 0); width: 348.29pt; height: 26.31pt;">교육내용</td><td valign="center" style="background: rgb(191, 191, 233); padding: 1.41pt 5.1pt; border: 0.28pt solid rgb(0, 0, 0); width: 73.78pt; height: 26.31pt;">소요시간</td></tr><tr><td valign="center" style="padding: 1.41pt 5.1pt; border: 0.28pt solid rgb(0, 0, 0); width: 53.97pt; height: 26.31pt;"><p class="0" style="text-align: center; line-height: 130%; text-indent: -30.3pt; margin-left: 30.3pt; -ms-text-autospace:; -ms-word-break: keep-all; mso-pagination: none; mso-padding-alt: 0.0pt 0.0pt 0.0pt 0.0pt;">1</td><td valign="center" style="padding: 1.41pt 5.1pt; border: 0.28pt solid rgb(0, 0, 0); width: 348.29pt; height: 26.31pt;">의료기기통합정보시스템 사용자 교육</td><td valign="center" style="padding: 1.41pt 5.1pt; border: 0.28pt solid rgb(0, 0, 0); width: 73.78pt; height: 26.31pt;"><p class="0" style="text-align: center; line-height: 130%; text-indent: -30.3pt; margin-left: 30.3pt; -ms-text-autospace:; -ms-word-break: keep-all; mso-pagination: none; mso-padding-alt: 0.0pt 0.0pt 0.0pt 0.0pt;">’120</td></tr><tr><td valign="center" style="padding: 1.41pt 5.1pt; border: 0.28pt solid rgb(0, 0, 0); width: 53.97pt; height: 26.31pt;"><p class="0" style="text-align: center; line-height: 130%; text-indent: -30.3pt; margin-left: 30.3pt; -ms-text-autospace:; -ms-word-break: keep-all; mso-pagination: none; mso-padding-alt: 0.0pt 0.0pt 0.0pt 0.0pt;">2</td><td valign="center" style="padding: 1.41pt 5.1pt; border: 0.28pt solid rgb(0, 0, 0); width: 348.29pt; height: 26.31pt;">질의응답</td><td valign="center" style="padding: 1.41pt 5.1pt; border: 0.28pt solid rgb(0, 0, 0); width: 73.78pt; height: 26.31pt;"><p class="0" style="text-align: center; line-height: 130%; text-indent: -30.3pt; margin-left: 30.3pt; -ms-text-autospace:; -ms-word-break: keep-all; mso-pagination: none; mso-padding-alt: 0.0pt 0.0pt 0.0pt 0.0pt;">’30</td></tr></tbody></table>