의료기기 수입신고, 더욱 간편해집니다

의료기기 수입신고, 더욱 간편해집니다: - 관세청, 식약처와 협업으로 의료기기 수입허가 정보 13종 입력 자동화
- 연간 약 33,167시간의 업무시간 및 약 3억 원의 인건비 절감 효과 기대; 2024.02.28 10:01 입력

<table width="700" align="center" class="center" id="news_image"><tbody><tr><td><img width="700" align="absmiddle" src="http://josetongsin.com/PEG/17090819336002.jpg"><div id="news_caption"> ▲ 정부대전청사- 관세청 전경</div></td></tr></tbody></table>  관세청과 식품의약품안전처(이하 ‘식약처’)는 의료기기를 수입하면서 반드시 거쳐야 하는 사전 승인 절차인 표준통관예정보고가 29일(목)부터 간편해진다고 밝혔다.  표준통관예정보고는 의료기기·의약품 등의 무자격·무허가 수입으로 인한 국민건강 위해물품의 반입을 차단하기 위해 수입자가 수입신고 전에 미리 관련 협회로부터 승인받는 절차이다.  기존에는 민원인이 관세청 통관단일창구(Uni-Pass)에서 표준통관예정보고서를 작성할 때 식약처 등으로부터 사전에 승인받은 허가정보를 일일이 직접 입력해야 하는 불편함이 있었다.  <img width="442" height="151" style="width: 715px; height: 215px;" src="data:image/png;base64,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" v:shapes="_x143629016"><div align="left"></div>  관세청은 이러한 불편 사항을 해소하고자 식약처로부터 사전 허가정보 13종을 공유받아 관세청 통관단일창구에 자동 입력되도록 개선했다고 설명했다. <table align="center" style="border: 0.28pt solid rgb(0, 0, 0); border-image: none; width: 718px; height: 95px; border-collapse: collapse;"><tbody><tr><td valign="center" style="border-width: medium medium 0.28pt; border-style: none none dotted; border-color: currentColor currentColor rgb(0, 0, 0); width: 135.16pt; height: 3.82pt;"></td><td valign="center" style="border: currentColor; border-image: none; width: 249.43pt; height: 14.82pt;" rowspan="2">< 자동입력 허가정보(13종) ></td><td valign="center" style="border-width: medium medium 0.28pt; border-style: none none dotted; border-color: currentColor currentColor rgb(0, 0, 0); width: 122.8pt; height: 3.82pt;"></td></tr><tr><td valign="center" style="border-width: 0.28pt medium medium 0.28pt; border-style: dotted none none dotted; border-color: rgb(0, 0, 0) currentColor currentColor rgb(0, 0, 0); width: 135.16pt; height: 11pt;"></td><td valign="center" style="border-width: 0.28pt 0.28pt medium medium; border-style: dotted dotted none none; border-color: rgb(0, 0, 0) rgb(0, 0, 0) currentColor currentColor; width: 122.8pt; height: 11pt;"></td></tr><tr><td valign="center" style="border-width: medium 0.28pt 0.28pt; border-style: none dotted dotted; border-color: currentColor rgb(0, 0, 0) rgb(0, 0, 0); width: 507.39pt; height: 60.82pt;" colspan="3"> ∎ 수입업 허가정보(2종) : 수입업 허가번호, 수입업자 허가구분 ∎ 품목 허가정보(11종) : 의료기기 분류번호, 분류등급코드, 품목한글명, 품목영문명, 모델명, 제조원·제조의뢰자 상호, 제조원·제조의뢰자 주소, 제조원·제조의뢰자 국가 한글명, 제조원·제조의뢰자 국가 영문명, 품목허가(신고)번호, 품목허가(신고)일자</td></tr></tbody></table>  그러면서 “이번 입력 자동화는 관세청이 지난해부터 중점 추진 중인 ‘스마트혁신’ 세부 과제 중 하나로, 지난 5개월간 식약처와 지속 협력한 결과”라며 “이번 제도개선으로 의료기기 수입자의 약 33,167시간의 업무시간과 약 3억 2,703만 원의 인건비가 연간 절감[의료기기 수입신고 건수(’23 기준 19.9만건) × 10분(건당 입력시간) × 9,860원(’24 최저시급)]될 것으로 보이며, 수기 입력 시 발생하는 오류를 방지하는 효과도 기대된다”고 강조했다.  관세청과 식약처는 앞으로도 국민 편의 제고와 신속 통관을 위해 이와 같은 제도개선을 의약품, 화장품, 인체조직 등 유사 분야로 적극 확대해 나갈 예정이라고 밝혔다.