{"id":11046,"date":"2020-01-13T00:33:44","date_gmt":"2020-01-13T00:33:44","guid":{"rendered":"https:\/\/bizlawyer.vn\/new-points-of-decree-no-03-2020-nd-cp-issued-by-the-government-on-january-1-2020-on-management-of-medical-equipment"},"modified":"2020-01-13T00:34:52","modified_gmt":"2020-01-13T00:34:52","slug":"nhung-diem-moi-cua-nghi-dinh-so-03-2020-nd-cp-duoc-chinh-phu-ban-hanh-ngay-01-01-2020-ve-quan-ly-trang-thiet-bi-y-te","status":"publish","type":"post","link":"https:\/\/bizlawyer.vn\/vi\/nhung-diem-moi-cua-nghi-dinh-so-03-2020-nd-cp-duoc-chinh-phu-ban-hanh-ngay-01-01-2020-ve-quan-ly-trang-thiet-bi-y-te","title":{"rendered":"Nh\u1eefng \u0111i\u1ec3m m\u1edbi c\u1ee7a Ngh\u1ecb \u0111\u1ecbnh s\u1ed1 03\/2020\/N\u0110-CP \u0111\u01b0\u1ee3c Ch\u00ednh ph\u1ee7 ban h\u00e0nh ng\u00e0y 01\/01\/2020 v\u1ec1 qu\u1ea3n l\u00fd trang thi\u1ebft b\u1ecb y t\u1ebf."},"content":{"rendered":"<p>Ng\u00e0y 01\/01\/2020, Ch\u00ednh ph\u1ee7 \u0111\u00e3 ban h\u00e0nh Ngh\u1ecb \u0111\u1ecbnh s\u1ed1 03\/2020\/N\u0110-CP \u0111\u1ec3 s\u1eeda \u0111\u1ed5i, b\u1ed5 sung c\u00e1c kho\u1ea3n 5, 6, 11 \u0110i\u1ec1u 68 (\u0110i\u1ec1u kho\u1ea3n chuy\u1ec3n ti\u1ebfp) c\u1ee7a Ngh\u1ecb \u0111\u1ecbnh s\u1ed1 36\/2016\/N\u0110-CP \u0111\u00e3 \u0111\u01b0\u1ee3c s\u1eeda \u0111\u1ed5i, b\u1ed5 sung t\u1ea1i Ngh\u1ecb \u0111\u1ecbnh s\u1ed1 169\/2018\/N\u0110-CP v\u1ec1 qu\u1ea3n l\u00fd trang thi\u1ebft b\u1ecb y t\u1ebf. C\u1ee5 th\u1ec3 nh\u01b0 sau:<br \/>\n\u0110\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf thu\u1ed9c lo\u1ea1i B, C, D:<br \/>\nN\u1ebfu thu\u1ed9c danh m\u1ee5c ph\u1ea3i c\u1ea5p gi\u1ea5y ph\u00e9p nh\u1eadp kh\u1ea9u v\u00e0 \u0111\u00e3 \u0111\u01b0\u1ee3c \u0111\u01b0\u1ee3c c\u1ea5p trong n\u0103m 2018, 2019, 2020, 2021: Gi\u1ea5y ph\u00e9p s\u1ebd ti\u1ebfp t\u1ee5c c\u00f3 gi\u00e1 tr\u1ecb \u0111\u1ebfn h\u1ebft ng\u00e0y 31\/12\/2021, \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n nh\u1eadp kh\u1ea9u v\u1edbi s\u1ed1 l\u01b0\u1ee3ng kh\u00f4ng h\u1ea1n ch\u1ebf v\u00e0 kh\u00f4ng b\u1ecb C\u01a1 quan h\u1ea3i quan ki\u1ec3m so\u00e1t.<br \/>\nN\u1ebfu kh\u00f4ng thu\u1ed9c danh m\u1ee5c ph\u1ea3i c\u1ea5p gi\u1ea5y ph\u00e9p nh\u1eadp kh\u1ea9u: S\u1ebd \u0111\u01b0\u1ee3c ti\u1ebfp t\u1ee5c nh\u1eadp kh\u1ea9u \u0111\u1ebfn h\u1ebft ng\u00e0y 31\/12\/2021 theo nhu c\u1ea7u, kh\u00f4ng h\u1ea1n ch\u1ebf s\u1ed1 l\u01b0\u1ee3ng, kh\u00f4ng c\u1ea7n v\u0103n b\u1ea3n x\u00e1c nh\u1eadn l\u00e0 trang thi\u1ebft b\u1ecb y t\u1ebf c\u1ee7a B\u1ed9 Y t\u1ebf khi th\u1ef1c hi\u1ec7n th\u1ee7 t\u1ee5c th\u00f4ng quan.<br \/>\n\u0110\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf thu\u1ed9c lo\u1ea1i A:<br \/>\nN\u1ebfu \u0111\u00e3 c\u00f3 phi\u1ebfu ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng do S\u1edf Y t\u1ebf c\u1ea5p: s\u1ebd ti\u1ebfp t\u1ee5c \u0111\u01b0\u1ee3c nh\u1eadp kh\u1ea9u theo nhu c\u1ea7u, kh\u00f4ng h\u1ea1n ch\u1ebf s\u1ed1 l\u01b0\u1ee3ng, kh\u00f4ng c\u1ea7n b\u1ea3n ph\u00e2n lo\u1ea1i v\u00e0 v\u0103n b\u1ea3n x\u00e1c nh\u1eadn l\u00e0 trang thi\u1ebft b\u1ecb y t\u1ebf c\u1ee7a B\u1ed9 Y t\u1ebf khi th\u1ef1c hi\u1ec7n th\u1ee7 t\u1ee5c th\u00f4ng quan;<br \/>\n\u0110\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf l\u00e0 sinh ph\u1ea9m ch\u1ea9n \u0111o\u00e1n in vitro:<br \/>\nN\u1ebfu \u0111\u00e3 \u0111\u01b0\u1ee3c c\u1ea5p gi\u1ea5y ph\u00e9p nh\u1eadp kh\u1ea9u trong n\u0103m 2018, 2019, 2020, 2021: Gi\u1ea5y ph\u00e9p s\u1ebd ti\u1ebfp t\u1ee5c c\u00f3 gi\u00e1 tr\u1ecb \u0111\u1ebfn h\u1ebft ng\u00e0y 31\/12\/2021, \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n nh\u1eadp kh\u1ea9u v\u1edbi s\u1ed1 l\u01b0\u1ee3ng kh\u00f4ng h\u1ea1n ch\u1ebf v\u00e0 kh\u00f4ng b\u1ecb C\u01a1 quan h\u1ea3i quan ki\u1ec3m so\u00e1t.<br \/>\nN\u1ebfu \u0111\u00e3 \u0111\u01b0\u1ee3c c\u1ea5p gi\u1ea5y \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh theo quy \u0111\u1ecbnh c\u1ee7a Lu\u1eadt d\u01b0\u1ee3c n\u0103m 2005 v\u00e0 c\u00e1c v\u0103n b\u1ea3n h\u01b0\u1edbng d\u1eabn thi h\u00e0nh Lu\u1eadt n\u00e0y th\u00ec s\u1ed1 l\u01b0u h\u00e0nh \u0111\u00e3 \u0111\u01b0\u1ee3c c\u1ea5p c\u00f3 gi\u00e1 tr\u1ecb s\u1eed d\u1ee5ng \u0111\u1ebfn h\u1ebft th\u1eddi gian ghi tr\u00ean gi\u1ea5y \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh. Tr\u1eeb tr\u01b0\u1eddng h\u1ee3p s\u1ed1 l\u01b0u h\u00e0nh ghi nh\u1eadn s\u1ebd h\u1ebft hi\u1ec7u l\u1ef1c sau ng\u00e0y 01\/01\/2019 v\u00e0 tr\u01b0\u1edbc ng\u00e0y 31\/12\/2021 th\u00ec s\u1ed1 l\u01b0u h\u00e0nh \u0111\u00e3 \u0111\u01b0\u1ee3c c\u1ea5p c\u00f3 gi\u00e1 tr\u1ecb s\u1eed d\u1ee5ng \u0111\u1ebfn h\u1ebft ng\u00e0y 31\/12\/2021;<br \/>\n\u0110\u1ed1i v\u1edbi H\u1ed3 s\u01a1 k\u1ef9 thu\u1eadt chung ASEAN (CSDT):<br \/>\nS\u1ebd \u0111\u01b0\u1ee3c \u00e1p d\u1ee5ng th\u1ef1c hi\u1ec7n k\u1ec3 t\u1eeb ng\u00e0y 31\/12\/2021. Theo \u0111\u00f3, k\u1ec3 t\u1eeb ng\u00e0y 31\/12\/2021, c\u00e1c c\u01a1 s\u1edf \u0111\u1ec1 ngh\u1ecb c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh kh\u00f4ng ph\u1ea3i cung c\u1ea5p c\u00e1c gi\u1ea5y t\u1edd quy \u0111\u1ecbnh t\u1ea1i \u0111i\u1ec3m g, i, m kho\u1ea3n 1 \u0110i\u1ec1u 26 c\u1ee7a Ngh\u1ecb \u0111\u1ecbnh s\u1ed1 36\/2016\/N\u0110-CP.<br \/>\nNgh\u1ecb \u0111\u1ecbnh 03\/2020\/N\u0110-CP c\u00f3 hi\u1ec7u l\u1ef1c c\u00f9ng v\u1edbi ng\u00e0y k\u00fd ban h\u00e0nh, t\u1ee9c nh\u1eb1m ng\u00e0y 01\/01\/2020.<br \/>\nT\u00f3m l\u1ea1i, Ngh\u1ecb \u0111\u1ecbnh 03\/2020\/N\u0110-CP s\u1eeda \u0111\u1ed5i c\u00e1c Ngh\u1ecb \u0111\u1ecbnh tr\u01b0\u1edbc \u0111\u00f3 v\u1ec1 \u0111i\u1ec1u kho\u1ea3n chuy\u1ec3n ti\u1ebfp, \u0111\u00e2y l\u00e0 \u0111i\u1ec1u kho\u1ea3n r\u1ea5t quan tr\u1ecdng \u0111\u1ed1i v\u1edbi m\u1ed9t v\u0103n b\u1ea3n quy ph\u1ea1m ph\u00e1p lu\u1eadt, gi\u00fap ch\u00fang ta x\u00e1c \u0111\u1ecbnh c\u1ee5 th\u1eddi h\u1ea1n c\u1ee7a gi\u1ea5y ph\u00e9p nh\u1eadp kh\u1ea9u, gi\u1ea5y \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh \u0111\u00e3 \u0111\u01b0\u1ee3c \u0111\u01b0\u1ee3c c\u1ea5p tr\u01b0\u1edbc \u0111\u00f3 \u0111\u1ed1i v\u1edbi t\u1eebng lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf, l\u00e0 c\u01a1 s\u1edf \u0111\u1ec3 c\u00e1c t\u1ed5 ch\u1ee9c, c\u00e1 nh\u00e2n c\u00f3 li\u00ean quan \u0111\u1ebfn ho\u1ea1t \u0111\u1ed9ng s\u1ea3n xu\u1ea5t, mua b\u00e1n, nh\u1eadp kh\u1ea9u, th\u1ef1c hi\u1ec7n d\u1ecbch v\u1ee5 trang thi\u1ebft b\u1ecb y t\u1ebf ti\u1ebfn h\u00e0nh c\u00e1c c\u00f4ng vi\u1ec7c c\u1ea7n thi\u1ebft \u0111\u1ec3 duy tr\u00ec c\u00e1c \u0111i\u1ec1u ki\u1ec7n c\u00f3 li\u00ean quan, \u0111\u1ea3m b\u1ea3o tu\u00e2n th\u1ee7 \u0111\u00fang c\u00e1c quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt v\u1ec1 qu\u1ea3n l\u00fd trang thi\u1ebft b\u1ecb y t\u1ebf.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Ng\u00e0y 01\/01\/2020, Ch\u00ednh ph\u1ee7 \u0111\u00e3 ban h\u00e0nh Ngh\u1ecb \u0111\u1ecbnh s\u1ed1 03\/2020\/N\u0110-CP \u0111\u1ec3 s\u1eeda \u0111\u1ed5i, b\u1ed5 sung c\u00e1c kho\u1ea3n 5, 6, 11 \u0110i\u1ec1u 68 (\u0110i\u1ec1u kho\u1ea3n chuy\u1ec3n ti\u1ebfp) c\u1ee7a Ngh\u1ecb \u0111\u1ecbnh s\u1ed1 36\/2016\/N\u0110-CP \u0111\u00e3 \u0111\u01b0\u1ee3c s\u1eeda \u0111\u1ed5i, b\u1ed5 sung t\u1ea1i Ngh\u1ecb \u0111\u1ecbnh s\u1ed1 169\/2018\/N\u0110-CP v\u1ec1 qu\u1ea3n l\u00fd trang thi\u1ebft b\u1ecb y t\u1ebf. C\u1ee5 th\u1ec3 nh\u01b0 sau: [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":11042,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-11046","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-bai-viet"],"_links":{"self":[{"href":"https:\/\/bizlawyer.vn\/vi\/wp-json\/wp\/v2\/posts\/11046","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/bizlawyer.vn\/vi\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/bizlawyer.vn\/vi\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/bizlawyer.vn\/vi\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/bizlawyer.vn\/vi\/wp-json\/wp\/v2\/comments?post=11046"}],"version-history":[{"count":0,"href":"https:\/\/bizlawyer.vn\/vi\/wp-json\/wp\/v2\/posts\/11046\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/bizlawyer.vn\/vi\/wp-json\/wp\/v2\/media\/11042"}],"wp:attachment":[{"href":"https:\/\/bizlawyer.vn\/vi\/wp-json\/wp\/v2\/media?parent=11046"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/bizlawyer.vn\/vi\/wp-json\/wp\/v2\/categories?post=11046"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/bizlawyer.vn\/vi\/wp-json\/wp\/v2\/tags?post=11046"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}